Managing Director, Strickland Quality Assurance Ltd (Course Principal)
Head of Research Quality Assurance, BIAL-Portela & Companhia SA
Director and Owner, Dove Quality Solutions
Chief Quality Officer, Nordic Nanovector
"Thank you very much! It was great to hear your experiences from doing the job and getting examples what can go wrong and how to avoid it."
"The presentations were relevant and well designed. The workshops give you a clear understanding of the work."
"Nice and clear and explained well, enjoyed the exercise and his input."
Please note timings may be subject to alteration
|09.15||Welcome and Objectives for the first day of the course|
|10.00||Today's Regulatory Framework
A brief review of the regulations and guidelines that describe Good Clinical Practice.
Requirements for informed consent and ethics committees.
Access to source documentation.
|13.35||Effective Site Audits
The procedures involved in selecting and setting up audits at investigator sites.
Determining the acceptability of data
|14.30||Workshop 1 - Planning the Effective Audit|
|15.45||Source Data Verification
The need for and purpose of verifying data.
|16.15||Workshop 2 - Source Data Verification|
|18.00||Close of day|
The requirements surrounding the distribution, storage, and administration of investigational medicinal products.
Accountability from release to destruction.
|9.30||Workshop 3 - IMP Accountability|
|11.05||Critical Document Audits
The conduct of other study specific audits including protocols.
|11.35||Auditing Third Parties
A review of audits of contract research organisations.
The concept of auditing processes across many clinical trials, including a practical exercise in process mapping.
Where theory meets reality.
|14.30||Audit Reports - Closing the Loop
An examination of the processes which follow the evidence gathering phase of the audit.
|15.25||Workshop 4 - Audit Reports
Audit reports, corrective and preventive action.
Auditors and regulatory inspections -how the QA team can help the organisation to perform during a regulatory inspection.
|17.25||Fraud - Fact or Fiction?|
|18.00||Close of course|
Following requests from attendees of previous RQA events we are pleased to offer course material in PDF format for delegates attending this course.
The material will be emailed in advance of the course and RQA will not be providing any printed copies of the course notes during the training itself. Delegates wishing to have a hard copy of the notes should print these in advance to bring with them. Alternatively delegates are welcome to bring along their own portable devices to view the material during the training sessions.