| Mastering Clinical Audit - (Short Course) |
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| Mastering Clinical Audit is a short online course which can be started at any time. It is designed for health professionals of any discipline to learn online the skills involved in effective multi-professional clinical audit. | | Funding/Fees | The fee per person is £145. This allows full access to the course for 28 days from the first time you log in.
For group of 10 or more registrations they offer a 10% discount and for groups of 50 or more a 20% discount. |
| Evaluation and Audit Service - (Short Course) |
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Our Evaluation and audit service is useful for organisations who want to understand whether their child protection training or training strategies:
*Provide value for money
*Develop the competence of practitioners
*Provide effective support for the implementation of policies and procedures
*Identify gaps in policies, skills and service provision
*Enable them to measure progress following inquiry or inspection reports.
The evaluation programme can be requested in relation to courses designed and delivered by the NSPCC or courses delivered by other trainers or training organisations. It can be provided at the following levels:
Impact level
This course report provides a statistical breakdown and narrative on the training given, and learning response of participants. The report will provide data in respect of participant's attendance and a SNAP analysis.
Learning level
This service explores how well participants have gained and applied their learning in the three to six months following a course. It also looks at what has hindered or assisted that learning. The evaluation can measure influence and impact on individual professional practice and service delivery.
Organisational level
This audit service measures influence and impact on practice and service in relation to organisational mandates or specific directives. These might arise from legislative changes, inquiry or inspection reports, or serious case reviews. This will enable you to ascertain whether training has resulted in changes within the organisation in line with any strategy or action plan. |
| The Auditing Course - (Workshop/Seminar) |
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This course is specifically designed to develop auditing skills and to give an insight into the role of the audit programme in achieving regulatory compliance and quality improvement. The course has been designed to complement BARQA’s research quality assurance courses; Research Quality Assurance for Good Laboratory Practice, Good Clinical Practice Auditing – Principles and Practice and Good Manufacturing Practice for Investigational Medicinal Products.
The course is applicable to any area of regulated research and development. It is particularly valuable where there is a quality system (e.g. GCP, GLP, GMP, ISO 9000) requirement for audit.
Benefits include improved:
* organisation of the audit programme to maximise its contribution to quality
* audit planning and conduct
* effectiveness in communicating audit outcomes
* corrective and preventative action | | Requirements | In order to benefit from the course, personal experience of audit is essential. | | Funding/fees | Association Members £750 inc VAT
Non Members £910 inc VAT
The Member rate is available, as a concession, to those working in relevant charities and academic institutions, or for the National Health Service. | | Date(s) | 23/11/2010 to 24/11/2010 |
| Observation and Recording for Auditors - (Workshop/Seminar) |
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Auditing involves the selection and examination of data and documentation, asking questions and the inspection of facilities and work in progress in order to provide assurance of good quality.
This course has been specifically designed for auditors to develop and refine the personal skills necessary to make and record accurate observations. The focus will be on practising and developing these skills, either individually or in small groups.
| | Funding/Fees | Association Members £750 inc VAT
Non Members £910 inc VAT
The Member rate is available, as a concession, to those working in relevant charities and academic institutions, or for the National Health Service (or its equivalent in other countries). | | Date(s) | 13/09/2010 to 15/09/2010 |
| Audit Analysis and Reporting - (Workshop/Seminar) |
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| This course will explore principles and best practice in the analysis and reporting of audit findings through informative presentations and practical exercises. | | Funding/Fees | COURSE FEES
Association Members £734 inc VAT
Non Members £891 inc VAT
The Member rate is available, as a concession, to those working in relevant charities and academic institutions, or for the National Health Service (or its equivalent in other countries). | | Date(s) | 16/09/2010 to 17/09/2010 |
| Good Clinical Practice (GCP) Auditing - Principles and Practice - (Workshop/Seminar) |
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This two and a half day course offers the ideal external training opportunity for those new to the auditing of clinical research and those moving into the area from monitoring or from auditing in other disciplines. It is directed principally towards the requirements of Good Clinical Practice and the methods for assuring that these requirements have been met.
The first afternoon of the course provides an introduction to Good Clinical Practice and is optional. The remaining two days concentrate on the practicalities of clinical audit. | | Future dates | 7th-9th March 2011 | | Funding/Fees | COURSE FEES
including optional first day
Association Members £785 inc VAT
Non Members £940 inc VAT
COURSE FEES
excluding optional first day
Association Members £725 inc VAT
Non Members £880 inc VAT | | Date(s) | 20/09/2010 to 22/09/2010 |
| Research Quality Assurance For Good Laboratory Practice (GLP) - (Workshop/Seminar) |
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This course offers the ideal external training opportunity for those starting out as Quality Assurance auditors or working under Good Laboratory Practice regulation for the first time.
| | Additional Information | The course is structured to encourage delegates to:
* discuss and develop ideas
* solve specific problems
* examine particular aspects of GLP | | Funding/Fees | Association Members £750 inc VAT
Non Members £910 inc VAT
The Member rate is available, as a concession, to those working in relevant charities and academic institutions, or for the National Health Service (or its equivalent in other countries). | | Date(s) | 12/10/2010 to 13/10/2010 |
| Implementing Good Clinical Laboratory Practice (GCLP) - (Workshop/Seminar) |
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This course is designed to provide comprehensive guidance and practical help for those who are implementing Good Clinical Laboratory Practice in laboratories which undertake the analysis of samples from clinical trials.
The course will address the current regulatory framework for laboratory work in support of clinical trials with reference to the ICH Guideline for Good Clinical Practice, the Clinical EU Trials Directive and related regulations and guidance. The course will also draw on the BARQA guidance document on Good Clinical Laboratory Practice (GCLP).
The course is structured to encourage delegates to:
* discuss and develop ideas
* solve specific problems
* examine particular aspects of GCP and GCLP
Benefits include:
* guidance on the interpretation and application of GCLP within the framework of Good Clinical Practice (GCP)
* understand how GCLP fits within a clinical (GCP) programme
* practical help on how to implement GCLP within a clinical research laboratory
* an opportunity to update your knowledge of GCLP with the current interpretation of requirements including guidance on clinical laboratories published by the UK Medicines and Healthcare Products Regulatory Agency (MHRA). | | Requirements | Who should attend:
Laboratory Managers, analysts, investigators, trial coordinators, monitors and auditors working in:
* pharmaceutical company laboratories
* central laboratories
* contract research organisations
* hospital laboratories
* clinics
* investigator sites. | | Funding/Fees | Association Members £750 inc VAT
Non Members £910 inc VAT
The Member rate is available, as a concession, to those working in relevant charities and academic institutions, or for the National Health Service. | | Date(s) | 22/03/2011 to 24/03/2011 |
| A Practical Guide to Clinical Audit - (Workshop/Seminar) |
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| This one day workshop provides a grounding in clinical audit methodology for healthcare professionals. | | Funding/fees | Places are free to UHBristol staff. Limited numbers of places are available to NHS staff from local healthcare community areas at a charge of £75 per person. | | Date(s) | 10/01/2011 |
| A Practical Guide to Pharmacovigilance and Drug Safety - (Short Course) |
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This 10-week self-study course has been specifically designed to give you a thorough understanding of pharmacovigilance and drug safety. Led by leading industry consultant Graeme Ladds, this course will teach you how to:
*Ensure your drug safety standards are being performed on a regular basis to avoid punitive measures being taken against you.
*Keep abreast of all the new safety reporting requirements so that you can run an efficient compliant safety department.
*Plan an effective surveillance system to monitor potential new signals and readjust risk/benefit for your products.
*Understand safety requirements and prepare for the increasing number of pharmacovigilance inspections conducted by regulatory agencies.
*Write standard operation procedures (SOPs) to cover the various aspects of drug safety and advise your staff on the requirements of safety reporting.
*Provide a seamless approach to drug safety for products undergoing both clinical and post-marketing assessments.
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| Managing Clinical Governance - (Workshop/Seminar) |
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If you’ve been designated to lead or manage clinical governance or to integrate governance functions, our course is intended to help you evaluate and lead your organization’s strategic, structural, systems, cultural and technical support for governance and assurance functions.
The course covers the components of clinical governance in detail and gives practical ideas for how to improve your organization’s current performance of each component and to integrate the functioning of the components:
quality improvement
implementation of evidence–based practice
clinical audit
patient experience and involvement
risk management including risk assessment, root cause analysis of events and patient safety
performance appraisal and continuing development programmes
communicating and leading the application of lessons learned. | | Future dates | 3 – 5 November 2010 | | Requirements | The course is for individuals who have been newly appointed to lead, facilitate, manage or support clinical governance functions. Individuals appointed to support clinical effectiveness, clinical audit, quality improvement, risk management, patient involvement or complaints handling programmes who are being integrated into new governance roles or structures will benefit from participation in the course. | | Date(s) | 03/11/2010 to 05/11/2010 |
| Advancing Clinical Audit - (Workshop/Seminar) |
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| The course helps participants improve clinical audit activities in their organizations. It provides practical advice on how to enhance key stages in the clinical audit process and helps participants think strategically about how to ensure that clinical audits actually benefit patients. | | Requirements | The course is for individuals who have at least one year’s experience in a job that involves supporting clinical audit and related programmes. The course also is suitable for clinical service managers. | | Date(s) | 06/10/2010 to 08/10/2010 |
| Using Clinical Audit to Improve Patient Care - (Workshop/Seminar) |
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| The course prepares new staff appointed to support clinical audit activities in their organizations. The course is aimed at helping staff to achieve evidence of improvements in patient care using the clinical audit process. | | Future dates | 6 - 10 December 2010
| | Requirements | The course is best suited to individuals who have just been appointed to jobs that involve supporting clinical audit or related programmes or to individuals who have been in the job for less than a year. | | Date(s) | 27/09/2010 to 01/10/2010 |
| Ethics for Clinical Audit Staff - (Workshop/Seminar) |
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This workshop is designed to help participants learn about the ethical issues related to clinical audit and other clinical governance activities and how to handle specific situations. The workshop is designed to help participants acquire competence in deciding when to refer projects to others for decision relating to ethics issues.
| | Requirements | The workshop is intended for clinical audit staff and clinical effectiveness and quality development staff. Managers and clinical leads for clinical audit or clinical governance will benefit from participating in the workshop. | | Funding/Fees | The cost varies according to the number of participants. | | Date(s) | 25/10/2010 |
| How to Teach Clinical Audit - (Workshop/Seminar) |
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Individuals in jobs that involve supporting clinical audit are often expected to give presentations about clinical audit and to teach clinical staff how to do a clinical audit. However, many of these individuals have had little formal training in being an effective presenter or teacher.
They have designed the course in response to requests from clinical audit staff who want to learn how we provide effective teaching on clinical audit. The course sets out a framework for designing any teaching session, provides a structured approach to planning what to teach and how, and gives advice on how to get learners involved in practical work. | | Requirements | The course is for experienced clinical audit staff who are expected to teach others how to do clinical audit. The course also is suited for clinicians designated to lead clinical audits and clinical tutors who may have responsibility for teaching clinical audit to doctors, nurses or other healthcare professionals in training. | | Date(s) | 18/11/2010 to 19/11/2010 |
| Getting Audit Right to Benefit Patients - (Workshop/Seminar) |
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| Many clinical audits take up a lot of staff time, but don’t actually lead to improvements in the quality or safety of patient care. Our half–, one–day or two–day workshops give clinical staff practical tools for selecting the right subjects for clinical audit and carrying out a clinical audit the right way to achieve tangible benefits for patients. | | Requirements | The workshop is designed for clinical staff who need or want to carry a clinical audit the right way. Doctors and other healthcare professionals in training programmes benefit from participation in the workshop. |
| Audit - (Workshop/Seminar) |
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(1 session) The concept of quality of care and the audit cycle are explored. Typically, a paper reporting a care audit is appraised (an observational study comparing 'before' and 'after') and its relevance to a decision scenario is considered. This topic frequently precedes a session on guidelines.
| | Additional Information | These CME accredited workshops allow training to be linked to local patient and service-delivery priorities. Questions that are important to clients can be addressed through the critical appraisal of related evidence, within the context of clinical governance. The workshops follow our characteristic problem-orientated, interactive learning format, which enables participants to ask questions, clarify points of difficulty and actively develop their critical appraisal skills. | | Funding/fees | The cost of commissioned workshops depends on location and the specific requirements of the programme (i.e. length, number of participants, number of tutors required). |
| Planning and Managing Clinical Trials - (Short Course) |
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This course comprises a single M level module, designed for those whose work involves them in clinical trials or who wish to become involved in such work. It provides training in line with the European directives on Clinical Trials and Good Clinical Practice (GCP). It offers an opportunity for students to gain an understanding the principles of planning and managing clinical trials on human volunteers. Students will be able to explore and apply relevant knowledge and skills to your own working environment. The module uses a blended learning approach which includes a detailed workbook supplemented by electronic learning materials. This Interactive learning is supported by Brookes’ virtual campus facility.
Unit description
1. Introduction to the module and literature skills
Includes general information about the module; an introduction to Brookes Virtual (contents, quizzes, electronic activities, assessments and discussion board); assessment criteria; literature searching and critical appraisal skills; databases.
2. Legislation and good clinical practice
Offers an overview of the European directives and legislation governing clinical trials in the 21st century; international perspectives; principles of the International Committee on Harmonisation (ICH)-GCP.
3. Drug development and trial planning
Explores drug development; pre-study requirements for clinical trials; regulatory approvals for clinical trials; Consort statement.
4. Trial responsibilities and protocols
Addresses the roles and responsibilities of investigators, sponsors and others; requirements of clinical trials protocols; legislative requirements for investigational medicinal products.
5. Project management in clinical trials
Introduces principles of project management; application in clinical trial management, risk assessment.
6. Research ethics and clinical trials
Examines the principles of research ethics, historical perspectives and current statutory requirements; ethical issues in clinical trials.
7. Consent and data protection
Explores the principles of informed consent; consent processes; data protection legislation and its application.
8. Data management
Introduces trial master files and essential documents; data management.
9. Quality assurance and governance
Addresses quality control in clinical trials; monitoring and audit; inspections; pharmacovigilance; research governance.
10. Trial closure and pitfalls
Examines trial closure, reporting and legal requirements; common pitfalls in clinical trial management. | | Additional Information | Level M 20 CATS points (equivalent to 10 ECTS credits). | | Requirements | Applicants need to meet the module’s minimum criteria in order to demonstrate that they will be able to study at an appropriate level. Applicants offered a place on the module must have reliable access to the Internet and email.
Note: Applicants whose home language is not English must demonstrate that their level of English is appropriate for study at postgraduate level with fluent writing skills. English language requirements are: IELTS level 6.5 or above, TOEFL 600/250 or above, WELT (BBC or above), or equivalent. | | Funding/fees | The cost of the module is £1,160 for UK/EU students (£1,210 for international students). |
| Clinical Trial Administration; an Introduction - (Short Course) |
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| This course aims to provide an introductory training for the CTA to help make sense of the background to clinical research and trial management. | | Additional Information | CPD Points: 10 | | Date(s) | 09/11/2010 |
| Good Pharmacovigilance Practice - (Workshop/Seminar) |
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Effective pharmacovigilance systems are important to protect the wellbeing of patients, meet regulatory requirements and protect the commercial interests of organisations which market medicinal products or are involved in clinical trials, either as sponsors or participants.
This course has been designed to bring clarity to the pharmacovigilance process. It will promote clear understanding of the regulatory requirements and explore best practice in discharging legal and commercial responsibilities for medicinal products for human use.
Benefits include:
• a clear understanding of
- the regulatory requirements for pharmacovigilance in the EU
- the common pharmacovigilance terms used
- the roles and responsibilities of all those involved in pharmacovigilance with particular emphasis on the PV Qualified Person
- what are reportable events and where they come from
- event assessment, follow-up and reporting
- obligations for periodic reporting, signal generation, trend analysis and complaint handling
- pharmacovigilance quality system requirements
• an insight into regulatory inspection activities and common inspection findings
This course is structured to encourage delegates to:
• discuss and develop ideas
• develop confidence in handling PV issues
• solve specific problems
• appreciate the wide scope of company responsibilities | | Requirements | Who should attend?
Qualified Persons responsible for Pharmacovigilance
Pharmacovigilance Scientists
Auditors
Regulatory Affairs Professionals
Medical Assessors
Marketing Managers
Statisticians
Information Scientists. | | Funding/fees | Association Members £750 inc VAT
Non Members £910 inc VAT
The Member rate is available, as a concession, to those working in relevant charities and academic institutions, or for the National Health Service. | | Date(s) | 05/10/2010 to 06/10/2010 |
| Process Mapping as a Management and Auditing Tool - (Workshop/Seminar) |
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| This course has been designed to make you a confident process mapper. You will be able to apply this new skill to describe and communicate processes and use mapping as a process improvement tool. If you are involved in writing standard operating procedures or protocols, managing their implementation, planning or conducting process audits, generating or utilising process performance metrics, solving problems and continual process improvement, this is the course for you. The course is designed for all those with responsibility for managing, documenting, implementing or auditing projects, processes and procedures. | | Future dates | 7th - 8th December 2010 | | Funding/Fees | Association Members £750 inc VAT
Non Members £910 inc VAT | | Date(s) | 07/12/2010 to 08/12/2010 |
| Systems Audit - (Workshop/Seminar) |
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This course is for established auditors who wish to gain practical experience of the planning, conduct and reporting of systems audits in a workshop setting before doing the real thing. It will also provide a valuable opportunity, for those already conducting systems audits, to benchmark their approach against those of the course tutors and other delegates. Delegates are encouraged to bring their own challenging systems to the course as audit case study material.
The course will assist you with:
* developing audit plans which anticipate the activities of regulatory inspectors
* defining and adhering to the objectives and scope of your audit
* identifying the audit client and meeting their compliance and quality improvement needs
In addition, the course will:
* develop auditor confidence and job satisfaction
* give auditors the tools necessary to improve their efficiency
* improve the effectiveness, focus and credibility of the audit programme
* drive improvement and value for money through thoroughly professional audit | | Funding/Fees | Association Members £750 inc VAT
Non Members £910 inc VAT
The Member rate is available, as a concession, to those working in relevant charities and academic institutions, or for the National Health Service (or its equivalent in other countries). | | Date(s) | 26/10/2010 to 27/10/2010 |
| Understanding FDA Audits Training - (Workshop/Seminar) |
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| To provide an awareness and understanding of FDA audits. | | Future dates | 7th October 2010, London, £420+VAT per learner (£483 inc. VAT).
4th November 2010, Glasgow, £399+VAT per learner (£458.85 inc. VAT).
14th January 2011, Edinburgh, £420+VAT per learner (£493.50 inc. VAT).
11th February 2011, Manchester, £420+VAT per learner (£493.50 inc. VAT).
11th March 2011, London, £440+VAT per learner (£517 inc. VAT).
15th April 2011, Dublin, Ireland, £440+VAT per learner (£517 inc. VAT).
13th May 2011, Leicester, £420+VAT per learner (£493.50 inc. VAT).
10th June 2011, Cork, Ireland, £440+VAT per learner (£517 inc. VAT).
15th July 2011, Manchester, £420+VAT per learner (£493.50 inc. VAT).
12th August 2011, London, £440+VAT per learner (£517 inc. VAT).
16th September 2011, Glasgow, £420+VAT per learner (£493.50 inc. VAT).
14th October 2011, Belfast, Ireland, £440+VAT per learner (£517 inc. VAT).
11th November 2011, Leicester, £420+VAT per learner (£493.50 inc. VAT).
2nd December 2011, London, £440+VAT per learner (£517 inc. VAT). | | Funding/fees | £458.85 inc. VAT | | Date(s) | 07/10/2010 |
| Effective Monitoring Visits - (Workshop/Seminar) |
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| What every monitor should know to be able to comply with the regulatory requirements for carrying out effective monitoring visits. | | Funding/fees | £1,290.00 | | Date(s) | 15/11/2010 to 16/11/2010 |
| Clinical Trial Authorisations and MHRA Inspections - Workshop Series - (Workshop/Seminar) |
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This CRGO workshop will cover:
What is a clinical trial?;
Current regulations governing clinical trials;
Clinical Trial Authorisation application process;
EudraCT and Public Access database registration;
MHRA Inspections process and common findings;
Lessons from the Parexel study at Northwick Park Hospital | | Funding/fees | Free of charge to staff at Imperial and their associated NHS Trusts |
| Clinical Audit Skills Distance Learning Course - (Short Course) |
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The Clinical Audit Skills Course is a one-year course that is offered on a distance-learning basis. The course is highly flexible and will be of benefit to healthcare professionals with no previous experience of audit through to those with a good understanding of the process.
All students who study for the course will be assigned a tutor who will provide support and help the student understand the audit process by undertaking a project relevant to their workplace. By the end of the course students will have an excellent understanding of the audit process and will also have gained invaluable experience of carrying out an audit that is relevant to their work. | | Additional Information | The course is accredited by the Open College Network and learners who successfully complete the course attain 3 credits at Level 3. Assessment for accreditiation is based on submission of a project plan and the completion of a clinical audit report.
The course will relate directly to several KSF dimensions - C1, C2, C3, C4, C5,IK1, IK2,IK3, G1,G2,G5 and G6. | | Funding/fees | The cost for studying for the distance-learning course is £550 plus VAT (£632.50). Group bookings are entitled to a discount of 10% |
| Advanced Clinical Audit - (Workshop/Seminar) |
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The Advanced Clinical Audit course is perfect for professionals who have a basic understanding of the clinical audit process and who want to learn more. The course would also suit staff who have recently started to work in the field of clinical audit or clinical governance.
The course provides an in depth guide into undertaking clinical audit at a more advanced level and learners who complete the workshop will confidently be able to facilitate their own projects and support audit work of healthcare colleagues. The workshop is highly interactive and challenging and learners will learn key concepts that healthcare professionals commonly become confused with – e.g. difference between audit and research, how to devise appropriate criteria and standards, etc. All delegates who attend the session will recieve a resource folder relevant to the workshop. | | Additional Information | The course is accredited by the Open College Network and learners who successfully complete the course attain 3 credits at Level 3. Assessment for accreditation is based on a short written assessment at the end of the training session.
The course will relate directly to several KSF dimensions – C1, C2, C3, C4, C5, IK1, IK2, IK3, G1, G2, G5 and G6. | | Date(s) | 22/09/2010 |
| Good Manufacturing Practice in Pharmaceutical Laboratories - (Workshop/Seminar) |
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This course is designed to provide comprehensive guidance and practical help for technical, supervisory personnel and supporting Quality Assurance within the pharmaceutical laboratory on approaches to take and what to look for when undertaking GMP analysis of pharmaceutical, biopharmaceutical and biological samples.
The course will address the current regulatory framework for laboratory work conducted to support GMP activities with reference to development, release and stability testing of Investigational and Commercial products. Comparison with relevant Good Laboratory Practices, in support of preclinical studies will be made.
Benefits include:
• guidance on the interpretation and application of Good Manufacturing Practice within the pharmaceutical laboratory
• an opportunity to improve your understanding of the GMP requirements as they are applied in the laboratory
• awareness and sharing of current regulatory inspection findings within the laboratory
• access to an experienced panel of speakers | | Requirements | Who should attend:
• technical personnel within the laboratory
• laboratory supervisors and managers
• quality assurance personnel supporting the laboratories/activities
• project managers responsible for outsourced laboratory work | | Funding/fees | Association Members £365 inc VAT
Non Members £415 inc VAT
The Member rate is available, as a concession, to those working in relevant charities and academic institutions, or for the National Health Service (or its equivalent in other countries) | | Date(s) | 15/09/2010 |
| Practical Pharmacovigilance Auditing - (Workshop/Seminar) |
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This course is for established auditors who wish to gain practical experience of the planning, conduct and reporting of pharmacovigilance audits in a workshop setting before doing the real thing. It will also provide a valuable opportunity, for those already conducting pharmacovigilance audits, to benchmark their approach against those of the course tutors and other delegates. Delegates are encouraged to bring their own challenges/issues to the course as audit case study material.
The course will assist you with:
• gaining practical approach to conducting pharmacovigilance audits through workshops
• enhancing your understanding of key pharmacovigilance audit’s principles, preparation, design and conduct
• developing your expertise, efficiency, confidence and job satisfaction
• having the necessary tools to improve effectiveness, focus, and credibility of the pharmacovigilance audit programme
In addition, the course will:
• develop auditor confidence and job satisfaction
• develop audit plans which anticipate the activities of regulatory pharmacovigilance inspectors
• benchmark your current working approaches against how other audit groups manage their program | | Funding/Fees | Association Members £750 inc VAT
Non Members £910 inc VAT
The Member rate is available, as a concession, to those working in relevant charities and academic institutions, or for the National Health Service (or its equivalent in other countries) | | Date(s) | 08/03/2011 to 09/03/2011 |
| Introduction to Clinical Audit - (Short Course) |
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The Introduction to Clinical Audit course is ideal for those professionals who would like to learn the key concepts involved in undertaking a clinical audit project. The course provides a step-by-step guide helping attendees get started with clinical audit. The session is highly interactive, practical and fun and those attending will leave with a full understanding of the clinical audit process. All delegates who attend the session will receive a resource folder relevant to the workshop.
| | Additional Information | The course is accredited by the Open College Network and learners who successfully complete the course attain 1 credit at Level 1. Assessment for accreditation is based on a short written assessment at the end of the training session.
The course will relate directly to several KSF dimensions – C1, C2, C3, C4, C5, IK1, IK2, IK3, G1, G2, G5 and G6. | | Funding/fees | The cost of a half-day training session is £400 plus travel and VAT. |
| Devising Clinical Audits - (Short Course) |
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The Devising Clinical Audits course is ideal for healthcare professionals who have a limited understanding of the clinical audit process and lack access to clinical audit support, but who are expected to deliver clinical audit projects.
Many healthcare staff must carry out a specific audit project but need advice, guidance and support. The Devising Clinical Audits course provides delegates with an overview of the clinical audit process and helps them develop their audit idea into a workable audit project. On completion of the course, delegates will understand the audit process and leave with a ready-made audit that they can implement within their service. All delegates who attend the session will receive a resource folder and an action plan for their proposed audit, including a relevant data collection form. | | Additional Information | Accreditation: There is currently no accreditation attached to this course.
KSF requirements: The course will relate directly to several KSF dimensions – C1, C2, C3, C4, C5, IK1, IK2, IK3, G1, G2, G5 and G6.
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| Introduction to Significant Event Audit - (Short Course) |
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The course is aimed at delegates who would like to gain an understanding of the significant event audit process and is ideal for those who have been tasked with setting up SEA meetings.
Significant event audit (SEA) is becoming increasingly important and popular within healthcare and the National Patient Safety Agency encourage teams to establish regular significant event audit meetings. The course will provide delegates from all sectors of healthcare a full overview of what is involved. Delegates who complete the course will possess the skills to establish SEA meetings within their organisation. | | Additional Information | The course is accredited by the Open College Network and learners who successfully complete the course attain 1 credit at Level 1. Assessment for accreditation is based on a short written assessment at the end of the training session.
KSF requirements: The course will relate directly to several KSF dimensions – C1, C3, C4, C5, HWB3, IK2 and G2. | | Funding/Fees | The cost of a half-day training session is £400 plus travel and VAT. |
| Auditing Computerised Systems - (Workshop/Seminar) |
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| This two and a half day course offers the ideal external training opportunity for auditors, those who manage audit programmes and those who will be audited, to develop the understanding and skills necessary for auditing the validation of computer systems intended for use in GxP (GLP, GCP, GMP, GDP, GPvP) environments. The course starts with an introduction to the regulatory requirements and the system life cycle and then concentrates on the practicalities of computer system validation audit. The course provides a mixture of presentations, discussions and practical workshops. | | Date(s) | 10/01/2011 to 12/01/2011 |
| GMP Auditor Training - (Short Course) |
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This 2 day course is aimed at Quality Assurance auditors and production management for Level 2 internal audits and supplier auditing.
To be a business benefit rather than a drain on resources, your auditing programmes must be integral to continuous improvement. The key to effective internal auditing and auditing of suppliers is the training of both auditors and auditees in the purpose and relevant techniques of the audit and how these techniques can be channelled to achieve business and compliance improvements.
Participants will learn about the key techniques and thought processes which may be used by auditors to maximize the benefits of each type of audit. These include planning and preparation, the audit team, structuring the audit, close out, CAPAs and follow up.
Day 1
Part 1: Auditing Basics
* Reasons for audits and audit models (overview)
* The Purpose of Audits
* Role Characteristics of the Auditor
* Audit Types
* Audit Classification
* Audit Methods
* General Themes for All Audits
Part 2: Auditing Tools and Techniques
* Basic tools
* Audit Techniques
* Audit Planning
DAY 2
Part 3: The audit process
* Audit scheduling
* Conducting the audit
* Managing the Audit Team
* The Exit Meeting
* Audit Reporting
* Audit Closeout
Part 4: Improving the audit system
* Adding Value from the Audit programme
Part 5: Added Value from Self Inspections (Level2 – QA Led)
* A practical Level 2 inspection programme (based on Auditor Training)
* Purpose of the self inspection programme
* Establishing the programme
* Setting up and training the inspection team
* Conducting the inspection and reporting. | | Funding/fees | Cost: £1160.00 + VAT (£1334.00) A reduced rate if booked with "How to Audit API Manufacturers"
£1584.00 + VAT (£1821.60).A discount of 10% if booked and paid by Friday 31 July 2009 | | Date(s) | 10/11/2010 to 11/11/2010 |
| Preparing for an Inspection & Audit - (Short Course) |
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This session will provide information on the following:
* Why a centre is chosen for an audit
* What will be inspected/ audited
* Investigator responsibilities
* Preparation of study documentation
* Protocol review, SAE’s, drug accountability
* Citations actions required following an audit.
At the end of this session the attendees will:
* Have an understanding of the process of an audit
* Be aware of the requirements/preparation for an audit/inspection
* Know the practicalities for surviving an audit
* Understand the regulations and the practical relevance. | | Requirements | This course would be suitable for:
Research Nurses, Trial Coordinators, Research Administrators, Investigators and any Healthcare Professionals involved in research. | | Date(s) | 30/11/2010 |
| Advanced Monitoring - (Short Course) |
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The role of the monitor is a very important one and there are a number of difficult issues which monitors may have to face. This course provides the following:
more in depth information on the role of the monitor
workshop sessions discussing issues
basic project and site management theory | | Requirements | The course is most suitable for monitors with at least 6 months experience, either of on-site monitoring or of managing contract on-site monitors.
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| Good Clinical Practice Training - (Workshop/Seminar) |
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Good Clinical Practice [GCP] is an international ethical and scientific quality standard for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials that involve human subjects. Compliance with GCP provides assurance that the clinical trial data are credible and accurate and that the rights, safety confidentiality and well-being of trial subjects are protected.
It is a requirement that all researchers and sites conducting research show GCP compliance and evidence of appropriate training. |
| Advanced Pharmacovigilance - (Short Course) |
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This course has been designed for persons with at least 2 years worth of knowledge in Drug Safety. The course will provide a very comprehensive and yet practical assessment of the main Regulations required to produce a compliant reporting Company.
This course would be of maximum benefit to those safety professionals who are working both in the Clinical and Post-Marketing Safety arena. The course covers very diverse activities within the Safety Department and would be advantageous to those who have either multifunction responsibilities or Medical Directors who manage teams in the various disciplines.
Key Topics to be covered:
* Due Diligence
* Training for Drug Safety - Reporting Duties
* Audits and Expectations
* Compliance and Drug Safety
* Independent Data Monitoring Boards
* Product Safety Reviews – Purpose and Function
* Safety Reporting in Licensing Agreements
* Developing Company Core Safety Information – CIOMS III
* PSURs
* The EU Clinical Trial Directive
* Risk/Benefit Determinations
* CIOMS V
* Crisis Management. | | Funding/fees | £1,640 + VAT | | Date(s) | 22/09/2010 to 24/09/2010 |
| Essential Guide to Clinical Trial Regulations - (Short Course) |
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The course is relevant for anyone involved with clinical trials or liaising/supporting Clinical research professionals in pharmaceutical, biotechnology CRO and SMO –companies, or study sites including investigator initiated studies.
The workshop will also be of interest to those departments who liaise with clinical trial personnel (such as regulatory affairs, clinical trial supply, quality assurance, document management, legal, regulatory authorities, and all other professionals who want to know more about regulations covering clinical trials).
Benefits of Attending:
* Decipher the framework of Clinical Trial Regulations in Europe
* Discuss the European Commission Assessment of the Clinical Trial Directive Consultative process
* What could be changed in a Review of the Directive?
* Gain an Overview of the EU Clinical Trial Directive and GCP Directive and some of the key issues
* Discuss Clinical Trials Authorisations: Regulatory Approval and Ethical Approval
* What are the Implications of Running clinical trials in Children: The Paediatric Plan and Ethical considerations
* Understand the Legal Aspects of Clinical Trials
* Ensure you Comply with Pharmacovigilance & Adverse Event Reporting
* Discuss Clinical Trial Data Management including EDC and e-source
* Understand FDA requirements
* What you need to know about Regulatory Inspections. | | Date(s) | 06/12/2010 to 07/12/2010 |
| Audit, Quality and Change in Health and Social Care - (Short Course) |
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| This module is for health and social care practitioners working within any health or social care environment who wish to promote and improve the quality of care to their patients/clients through the audit process. | | Additional Information | Assessment
• Essay
Number of credits & level of study - 15 credits at Level 5 or 6 | | Requirements | None |
| Preparing for MHRA Inspections - (Short Course) |
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Audits and inspections are a fact of life when running clinical trials. This course will provide delegates with:
* Information about how MHRA inspections are conducted
* Advice on preparing for inspections and providing information to inspectors
* Advice on responding to inspection findings
The course is suitable for all staff who may be involved in an inspection, for example, clinical operations staff, senior managers, investigators and other site staff. | | Funding/fees | The price for each course is £250 +VAT. If you are a freelancer, work for charity, academic institution or in the NHS then you qualify for the non-commercial rate of just £125 + VAT.
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| Preparing for Inspections - (Short Course) |
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Audits and inspections are a fact of life when running clinical trials. This course will provide delegates with:
* Information about how inspections are conducted
* Advice on preparing for inspections and providing information to inspectors
* Advice on responding to inspection findings
The course is suitable for all staff who may be involved in an inspection, for example, clinical operations staff, senior managers, investigators and other site staff. | | Funding/Fees | The price for each course is £250 +VAT. If you are a freelancer, work for charity, academic institution or in the NHS then you qualify for the non-commercial rate of just £125 + VAT.
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| Advanced Monitoring and CRA Skills - (Short Course) |
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| This practical course will introduce experienced monitors and CRAs to the more complex aspects of clinical trial monitoring and prepare them to work at a more senior level. This topic covers advanced study site management and monitoring of clinical trials. Topics include how to plan monitoring visits more effectively and proactively, how to use the criteria matrix to select the most appropriate investigators, monitoring various data collection methods (eg e-source). It also focuses on co-monitoring, dealing with difficult sites and how to motivate staff, problem solving, working under tight timelines, detecting fraudulent data, patient recruitment and retention issues, and appropriately documenting and reporting issues. This course will take you through these important areas of advanced monitoring to help ensure that you will be effective and meet the more stringent GCP inspection requirements that we now have in Europe. | | Funding/fees | £1,290.00 + VAT. | | Date(s) | 06/10/2010 to 07/10/2010 |
| Audits & Inspections: Preparation & Performance - (Workshop/Seminar) |
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| This course allows delegates to develop an effective strategy for undertaking a successful audit or inspection. | | Additional Information | 10 CPD Points | | Requirements | All clinical researchers likely to be involved, at any stage, in an audit or an inspection. | | Funding/fees | Member £425
Non-Member £510
Member Health Service / Academic £335 | | Date(s) | 15/09/2010 |
| Monitoring Skills; an Introduction - (Workshop/Seminar) |
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This course is designed to educate delegates in the role of a clinical research monitor and how the monitor interacts with other key roles in a clinical trial. Particular attention is paid to criteria for selecting Investigators, best practice for conducting monitoring visits, and safety reporting.
Course Outline
• Refresher of purpose of Good Clinical Practice
• The roles and responsibilities of
- Monitors
- Investigators
- Sponsors
- Ethics Committees
• Selecting Investigators – identifying sources
• Selecting Investigators – preparing and conducting the pre-study visit
• Essential Documents required before patient recruitment
• Conducting Initiation Visits – preparing and conducting the visit
• Essential Documents collected during patient recruitment
• Conducting monitoring visits
• Source data verification
• Safety reporting
• Investigational Medicinal Product Monitoring
• Informed consent
• Monitoring Visit Reports
• Prioritising activities
• Conducting close- out visits – planning and preparation
• Essential documents collected once patient recruitment has ended | | Requirements | This course is designed for people who are very new to clinical research monitoring and have been in the role for less than three months. It will also be useful for people who are just about to start a career in monitoring. | | Funding/Fees | Member £780
Non-Member £940
Member Health Service / Academic £625 | | Date(s) | 21/09/2010 to 22/09/2010 |
| Monitoring Skills for Non-commercial Trials - (Short Course) |
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A training course for monitoring clinical trials of Medicinal Products in the non-commercial sector
This two-day course will provide an introduction to the skills required for monitoring research in the UK non-commercial sector. The course will focus on monitoring of clinical research trials of medicinal products. The course is designed for all staff involved in monitoring, or supervising monitoring of clinical research e.g. R&D Managers, research governance staff, study coordinators, and investigator site staff. Enrolment is limited to 35 participants per course.
This course is run by ACRP in collaboration with the NHS R&D Forum. | | Future dates | 26-27 October -
6-7 December 2010 - The Nowgen Centre, 29 Grafton Street, Manchester, M13 9WU | | Funding/fees | Fees £425 per person for the two-day course. Please ensure you have funding approval BEFORE booking your place otherwise you will be held personally liable for any fees. | | Date(s) | 26/10/2010 to 27/10/2010 |
| Clinical Audit and Improvement 2011 - (Conference) |
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| Through a series of focus sessions, debates, panel discussions, workshops and poster presentations, this eleventh annual two day conference brings together and exceptional gathering of leading practitioner, clinicians, policy makers and academics to set out the major developments, promote innovative areas of work, and debate the key challenges affecting you and your organisation. | | Date(s) | 08/02/2011 to 09/02/2011 |
| Improving the Quality of Junior Doctor Led Clinical Audit - (Conference) |
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This conference will provide practical guidance on improving the quality of Junior Doctor clinical audit for Junior Doctors themselves and also cover the role of the Clinical Audit Team and Consultants in supporting the delivery of Junior Doctor clinical audit.
Topics to include:
• Improving Junior Doctor Clinical Audit
• How can we support Junior Doctors to deliver effective Clinical Audit projects that lead to change and improvement
• Is your Junior Doctor Clinical Audit Programme delivering quality improvement? ; Assessing your clinical audit programme against key performance indicators
• Overcoming the problem of Junior Doctor turnaround: developing linking schemes to ensure completed projects
• A Junior Doctor Audit for Patient Safety
• Junior Doctor Clinical Audit: Moving Forward, The Junior Doctors Perspective | | Date(s) | 18/11/2010 |
| Internal Auditor: ISO 13485 Medical Devices - (Workshop/Seminar) |
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| BSI’s “Internal Auditor: ISO 13485” course is intended for medical device quality professionals aiming to build on their current knowledge of ISO 13485:2003 and evaluate the effectiveness of the quality management system in their organization. This intensive two-day course teaches the principles and practices of effective quality management systems process audits in accordance with the ISO 13485 and ISO 19011:2002. An experienced instructor guides students through the internal audit process, from planning an audit to reporting on audit results and following up on corrective actions. Participants will gain necessary auditing skills through a balance of formal classroom tutorials, practical role-playing, and group workshops. | | Future dates | Hayley - Alexandra House, Swindon - 10 February 2011 to 11 February 2011
Hayley - Cranage Hall, South Manchester 20 June 2011 to 21 June 2011. | | Requirements | Who Should Attend?
- Medical Device Quality professionals with knowledge of quality management systems and ISO 13485
- Individuals interested in conducting first-party or second-party audits
- Management representatives
- Internal auditors
- Managers
- Consultants
Prerequisites: This course does not detail the requirements of ISO 13485:2003.
Prior knowledge of the ISO 13485 standard, such as the overview provided in BSI’s ‘Introduction to ISO 13485 or previous work with ISO 13485 in an organization, is strongly recommended as a prerequisite for this course. | | Funding/fees | £1,070.00+VAT. | | Date(s) | 22/11/2010 to 23/11/2010 |
| Lead Auditor ISO 13485 - (Workshop/Seminar) |
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| BSI’s “Lead Auditor: ISO 13485” course teaches the principles and practices of effective quality management systems and process audits in accordance with ISO 13485:2003 and ISO 19011:2002, “Guidelines for Quality and/or Environmental Management Systems Auditing.” Experienced instructors guide students through the entire audit process, from managing an audit program to reporting on audit results. Participants will gain necessary auditing skills through a balance of formal classroom tutorials, practical role-playing, group workshops, and open forum discussions. | | Future dates | Hayley - Eastwood Hall, Nottingham - 6 December 2010 to 10 December 2010
Hayley - Connaught Rooms - London - 14 February 2011 to 18 February 2011 | | Requirements | Who Should Attend?
- Medical Device quality professionals interested in conducting first-party, second-party, and/or third-party audits
- Management Representatives
- Quality Directors
- Managers
- Engineers
- Consultants
Prerequisites: A prior review of the ISO 13485:2003 standard and internal audit experience are strongly recommended for this course.
| | Funding/Fees | £2345.00+VAT Inc. Accommodation
£1925.00+VAT Excl. Accommodation | | Date(s) | 13/09/2010 to 17/09/2010 |
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