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Good Clinical Practice Auditing - Principles and Practice: The Essentials

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Course Information

Please note for the October 2020 course only a 10% discount is available when booked with a conference delegate package.  To take advantage of this discount, please add ALL items to your basket and enter SUPERPRECON in the discount code box.  This course may also be booked as a stand-alone course.

Course Tutors

Paul Strickland
Managing Director, Strickland Quality Assurance Ltd (Course Principal)

Susana Tavares
Head of Research Quality Assurance, BIAL-Portela & Companhia SA

Cathy Dove
Director and Owner, Dove Quality Solutions

Rosemarie Corrigan
Chief Quality Officer, Nordic Nanovector

Recent Feedback

"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."

CPD Points

14 Points

 

Course Programme

Please note timings may be subject to alteration

 

Day 1

09.00 Registration 
 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.
 10.55 Break 
 11.20 Patient Protection
Requirements for informed consent and ethics committees.
Access to source documentation.
 12.45  Lunch
 13.35 Effective Site Audits
The procedures involved in selecting and setting up audits at investigator sites.
14.10 Non-Compliance
Determining the acceptability of data
 14.30 Workshop 1 - Planning the Effective Audit
 15.20 Break 
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 
 

 Day 2

 8.50 IMP Management
The requirements surrounding the distribution, storage, and administration of investigational medicinal products.
Accountability from release to destruction. 
9.30 Workshop 3 - IMP Accountability
10.40 Break
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. 
 12.35 Lunch 
 13.25 System Audits
The concept of auditing processes across many clinical trials, including a practical exercise in process mapping. 
 14.00 Effective Audits
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. 
 15.05 Break 
 15.25 Workshop 4 - Audit Reports
Audit reports, corrective and preventive action. 
 16.15 Regulatory Inspection
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 

Course Material

Following requests from attendees of previous RQA events we are pleased to offer course material in PDF format for delegates attending this course. 

The advantages of this include

  • Ability for delegates to keep material on a mobile device
  • Ability to review material at any time pre and post course
  • Environmental benefits – less paper being used per 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.

 

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