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Short Course

Course Information
Course Title: Auditing GMP Regulated Laboratories: Preparation and Execution
Categories: 1 - Pharmaceutical Sciences
2 - Data Management
3 - Quality/Regulatory/Compliance
4 - Laboratory Information and Management
Instructor(s): Bob McDowall Course Number: 146
Affiliation: R D McDowall Ltd
Course Date: 03/07/2017 - Tuesday Course Length: 1 Day Course
Start Time: 08:30 AM End Time: 05:00 PM
Fee: $575 ($775 after 2/18/17) Textbook Fee:

Course Description
How do you know that the laboratories providing you with analytical data and results upon which product registration, product release or stability studies rely are scientifically sound and regulatory compliant? The GMP regulatory requirements for analytical laboratories are to be found in the 21 CFR 211 as well as EU GMP parts 1 and 2. In addition there are regulatory guidance documents from the FDA and PIC/S such as: • Quality System Review according to FDA’s Quality System Guidance • PIC/S Aide Memoire on the Inspection of Pharmaceutical Quality Control Laboratories • FDA Compliance Program Guide 7346.832 Chapter 46 – New Drug Evaluation Pre-Approval Inspections • FDA Guide to Inspection of Pharmaceutical Quality Control Laboratories Auditing is an independent mechanism to ensure that the regulatory requirements of GMP are in place within either an internal or external laboratory and demonstrate that the essential compliance elements are in place and that they work. The two specific learning objectives of this new course are firstly, how to audit GXP regulated labs in Pharma organisations and contract labs and secondly, how laboratory personnel can ensure compliance and be able to defend their positions. The scope of auditing a GMP laboratory will be developed during the course along with a risk based prioritisation of the key areas to focus audit attention on. The attendees will develop and review an auditing check list template to facilitate best audit practices as well as evaluate the results of a laboratory audit. Every participant will receive a checklist for the auditing of analytical laboratories.

Target Audience
This course will be of significant value to: Managers and scientists from Quality Control and Analytical Development need to know the audit process QA personnel CRO and CMO lab & QA personnel Auditors (internal and external) responsible for assessing laboratory results and GMP compliance

Course Outline
Introduction to the Course
Trust but Verify the Role of Auditing in GMP Laboratories
What Will We Audit Against?
Workshop 1: Identifying the Audit Scope of Laboratory Controls and Prioritising the Elements
Workshop 2: FDA Key Laboratory Concerns (based on 483 observations and warning letters)
Workshop 3: Preparing for the Audit
Workshop 4: Observations and Findings During a Laboratory Audit
Workshop 5: Planning Closing Meeting and Informing the Auditees
Review of the Course and Key Learning Points

Course Instructor's Biography
Dr BOB MCDOWALL, R D McDowall Limited, Bromley, Kent, UK An analytical chemist with over 40 years experience including 15 years working in the pharmaceutical industry and 20 years working for the industry as a consultant. He is Director of R D McDowall Ltd. Bob is an ISO 17025 assessor and he has been involved with the validation of computerised systems for over 20 years and is the author of a book on the validation of chromatography data systems. Bob is also 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. Dr CHRISTOPHER BURGESS, Burgess Analytical Consultancy Limited, Barnard Castle, UK Dr Burgess is a Chartered Chemist and has more than 39 years experience in the pharmaceutical industry primarily with Glaxo (now GSK) in Quality Control, Quality Assurance and Analytical R&D. He is a “QP”, Qualified Person, in the European Union and a member of the European QP Association advisory board. He has been appointed to the United States Pharmacopoeia’s Council of Experts 2010 to 2015 and is a visiting professor of the University of Strathclyde’s School of Pharmacy and Biomedical Sciences (SIPBS). In addition, he is the chairman of the ECA Analytical Quality Control Group and a member of the Executive committee of European Compliance Academy. He is also a Chartered European Chemist, a Chartered Scientist and a qualified ISO Guide 17025 assessor and was a member of the PDA Expert Working Group on Out of Specification results. He is an editorial board member of Pharmaceutical Technology and author of the Statistical Solutions column.