Objectives of the Presentation:
Upon completion of this course the participant should be able to:
1) Identify the critical Quality Systems used in Pharmaceutical Laboratories.
2) Understand the ‘building blocks’ for these systems and the rationale for each of them.
3) Be familiar with some of the regulatory expectations related to Quality Systems.
4) Develop a strategy to systematically enhance the Quality Systems in their laboratory.
5) Use the Quality Systems Approach to prepare for an inspection.
Areas Covered:
1) The Quality System Approach for Pharmaceutical Laboratories
2) How the Quality Systems Approach Prepares You for Regulatory Inspections
3) Critical Quality Systems
a) Documents and Change Control
i) Standard Operating Procedures, Methods and Specifications
b) Facility and Equipment Controls
i) Instruments and Stability Chambers
c) Material Controls
i) Raw Material and Product Testing; Reference Standards
d) Data Controls
i) Data Documentation and Review; Computerized Data; Atypical data; Stability
4) Attendee Questions and Answers
Who will benefit:
Scientists, Laboratory Managers and Quality Assurance personnel responsible for generating GMP or GLP data in a regulated pharmaceutical environment (pharmaceuticals, generics, OTC, contract labs).
Why you should attend:
If you are responsible for a pharmaceutical analytical laboratory, or work in one, then you want to make sure that the data generated meets the expectations of the regulatory agencies, but also need to be as efficient as possible. By adopting a Quality Systems approach, you can use the regulators ‘rule book’ to help you assure compliance, and by addressing their concerns and using some strategic thinking, you can maximize your efficiency in accomplishing this.
Greg Martin is President of Complectors Consulting (www.complectors.com) which provides consulting and training in the area of Pharmaceutical Analytical Chemistry. Mr. Martin has over 25 years experience in the pharmaceutical industry and was Director of Pharmaceutical Analytical Chemistry (R&D) for a major PhRMA company for a number of years. In addition, he has volunteered for the USP for over 10 years, and currently serves as Vice Chair of the General Chapters – Physical Analysis Expert Committee, and serves on Expert Panels on Validation and Verification, Weights and Balances, Residual Solvents and Use of Enzymes for Dissolution Testing of Gelatin Capsules. He has particular interest in QbD/Lean approaches to dissolution testing, impurity methods, method lifecycle (development/validation/transfer) and instrument qualification, and is passionate about using good science and sound logic to achieve high quality results, consistent with cGMPs, while minimizing resources. He is also Chair of the AAPS In Vitro Release and Dissolution Testing Focus Group. Mr. Martin is author of several papers in the areas of dissolution and analytical method validation.