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ICH Q7 API GMP Guidelines from an Insider’s Practical Perspective
- Reason for Development and International Adoption
- Membership and Countries Involved
- What is covered by the Guidance
- Key Sections to get Special Focus
- Critical or Important Sections and Concepts
- Facility and Equipment Issues
- Production and Controls
- Product Dating and Impact
- Validations verses Qualification
- Rejection and Re-use Issues
- Recovery Issues
- New Applications
- Where Flexibility Exists
- How should Q7 be applied
Overview of the webinar
This webinar will examine the history of Q7, the reason for its development, and reasons why it differs from Drug Product GMP. The reasons for differences are important to understand.
The program looks at the sections that make up API GMP, and during this limited time period, examine the most important sections and where special attention should be placed by both users and producers of API. This includes the practices and procedures that play critical roles in satisfying GMP as intended by the writers of this guidance.
Who should attend?
- QC and QA Personnel
- Manufacturing Supervision
- Quality Control and Quality Assurance Staff
- Warehousing Supervision
- Distribution Personnel
- Development Staff
- Validation Staff
- Maintenance Management
- Complaint Management
- Regulatory Management
Why should you attend?
This program is presented by an expert in the development and application of ICH Q7, the internationally accepted API GMP Guidance. Max Lazar was a voting member of the International Conference on Harmonization’s Expert Workgroup that negotiated and developed this important international Guidance. His expertise was developed during years of experience in the drug industry and as a chair of applicable PMA and PhRMA API and Quality Committees for the industry.
His personal involvement in the Q7 guidance allows him to share with participants an insider’s understanding of what the API GMP establishes for the industry and the reasons why they are or are not important. He is also knowledgeable with how these GMP differ from 21 CFR Part 211 and why this difference was necessary.
Faculty - Mr.Max Lazar
Max Lazar retired from Hoffmann-La Roche Inc. in 2001 after 35 years, where he was Vice President, FDA & DEA Compliance. In that position, he was responsible for compliance oversight of all of the Roche USA businesses including Active Pharmaceutical Ingredients, Pharmaceuticals, R&D, Diagnostics, Fine Chemicals and Vitamins. Following his retirement, he established a consulting business specializing in API GMP issues and the training of personnel covering the ICH Q7A Guidance as well as the Excipient GMP (IPEC) Guidance. As a voting member of the ICH Expert Work Group (EWG) that developed and negotiated this international standard, Max is uniquely qualified to share and explain the EWG’s intent of this new guidance.
His almost 50-year career in the Pharmaceutical Industry includes numerous memberships and chairs of committees. He founded and chaired the Pharmaceutical Manufacturers Association’s (PMA) Bulk Pharmaceutical Committee of the Quality Control Section. This chair lasted thru the reorganization of PMA into PhRMA and until Max’s retirement in 2001. He has presented at numerous meetings during his career including SOCMA, PDA, DIA, the original IVT, and PhRMA.
Max was named by PhRMA, Topic Leader and voting member of the ICH Q7A team that negotiated and developed the ICH API GMP document. For his contribution to Q7A, he was awarded the USA FDA Commissioner’s Special Citation “For outstanding cooperation and achievement in developing an internationally harmonized good manufacturing practice guidance for active pharmaceutical ingredients used in human drug products.”
He represented USA industry at significant API meetings including the BPC PIC/S Conference in Canberra, Australia and the WHO/CDC/FDA Diethylene Glycol Contamination Prevention Workshop that followed the Haitian tragedy where almost 100 children died. Max was named as PhRMA’s representative on the FDA PQRI initiative for the initial Bulk Substance projects. He was Vice Chair of the USP Pharmaceutical Waters Expert Committee (2000-2005), re-elected to another 5-year term (2005-2010) as a member of this USP Expert committee, and is currently an official member of the USP water panels (2010-2015).