NEW ON LINE SEMINAR
Tuesday, June 13th, 2023
16:00-20:00
WHO SHOULD ATTEND
This Live Online Training is designed for
- Managers and staff from Production, Quality Control and Analytical Development Laboratories of pharmaceutical companies and Contract Manufacturing Organization personnel,
- Quality Assurance staff involved in oversight of audit trail reviews or performing Data Integrity audits,
- Auditors (internal and external) responsible for performing self-inspections or external audits.
OBJECTIVES
The objectives of this Live Online Training are to provide:
- An understanding of the regulatory requirements for Audit Trail Review
- Understand how to manage the review by exception
- Who should perform the Second Person Review?
- Present examples of Audit Trail Entries for attendees to identify potential Data Integrity issues
SPEAKER
Dr Bob McDowall
Analytical chemist with over 30 years experience including 15 years working in the pharmaceutical industry. He has been a consultant for 18 years and trained auditor with 16 years experience. He has been involved with the validation of computerized systems for over 20 years and is the author of a book on the validation of chromatography data systems. Bob is the writer of the Questions of Quality (LC-GC Europe) and Focus on Quality (Spectroscopy) columns and is a member of the Editorial Advisory Boards of several journals.
TOPICS
Introduction
- Overview of the course
- Introduction to the trainer
- How Facilitated Discussions will be handled: www.menti.com
GMP Regulations and Guidance for Audit Trail Review
- Able Laboratories 483 observations, 2005
- Annex 11 requirements
- Regulatory guidance from WHO, PIC/S and FDA
- Second person review, data integrity audit and periodic review
- What are GMP relevant data and what are not…
Facilitated Discussion: Which Audit Trail to Review and When?
- Using the structure of a laboratory chromatography data system the group will explore which audit trails should be reviewed during:
- Second person review
- Data integrity audit
- Periodic review
Audit Trail Review in the Context of Second Person Review
- How audit trail review fits into an overall second person review
- Facilitated Discussion: What Are GMP Relevant Data?
- How will you focus an audit trail review? Understand what the regulations required in terms of GMP relevant changes and deletions
- Performing an Audit Trail Review
- Hybrid and electronic system audit trail reviews
- How technical controls can help you perform an audit trail review by exception if the process is validated
- Facilitated Discussion: System Audit Trail Review
- You will be given the audit trail entries from a networked computerised system
- You have to find if there are any problems to look further in depth at.
Participants will receive the notes and the Certification of Attendance by e-mail.
Payment will be made by bank transfer or direct deposit to the account of ALPHA BANK: GR66 0140 1230 1230 0232 0001 247 or
PIRAEUS BANK: GR 24 0172 0500 0050 5003 0221 686, up to 3 days before the beginning of the seminar.
Cancellations are accepted without charge up to 5 days prior to the seminar.
Registration - Info
AUDIT TRAIL REVIEW 13/06/23 - 13/06/23Take a few seconds to fill the following information. One of our representatives will call you soon.