This live, interactive training webinar will examine a variety of the issues surrounding raw materials to include what materials should be tested and to what extent during Phase 1, 2 and 3. It will cover testing requirements as part of “Laboratory Controls” during each Phase and what laboratory testing may be optional until the ingredient moves to its next Phase. It will determine what options exist - even within a Phase 2 or Phase 3 testing framework. It will discuss compendial vs. non-compendial testing and how to respond when no method is available. Within the past several years the FDA has also issued a significant number of Warning Letters pertaining to 21 CFR 211.84 which involve management of raw/in-coming materials and which correspond to various sections within ICH Q7A. Please plan to attend the upcoming 90-minute webinar to learn how to avoid receiving this common citation and maintaining compliance with ICH Q7A. Please plan to bring an interdisciplinary group to obtain the most from this webinar.
Why Should You Attend:
With the multi-national focus on both raw materials and the Active Pharmaceutical Ingredients formed from them, those involved in sourcing both the raw materials as well as those Active Pharmaceutical Ingredients must consider not only raw materials and APIs sourced within the U.S., but also overseas. The ICH Q7A Guidance provides harmonized guidance regarding the manufacturing of APIs up to that point where the APIs are rendered sterile. Whenever a material is classified as an API throughout the world, it should be manufactured according to the ICH Q7A guide regardless of where it is consumed.Areas Covered in the Webinar:
- Introductory information regarding API GMPs and ICH Q7 for pharma and biologic products
- Quality Risk Management, and Quality System Inspection Techniques
- Materials Management to Include Sampling and Testing of Raw Materials
- Laboratory Controls for Testing of In-Coming Raw Materials and Intermediates
- GMP Documentation and Change Controls
- Facilities and Utility System Design and Maintenance
- Processing and Process Equipment, and Production In-process Controls
Who Will Benefit:
- Quality Assurance
- Quality Control
- Microbiology/Analytical
- R&D Development
- Technical Services
- Validation
- Project Management
- Plant Management
Course Content
- Introductory information regarding API GMPs and ICH Q7 for pharma and biologic products
- Quality Risk Management, and Quality System Inspection Techniques
- Materials Management to Include Sampling and Testing of Raw Materials
- Laboratory Controls for Testing of In-Coming Raw Materials and Intermediates
- GMP Documentation and Change Controls
- Facilities and Utility System Design and Maintenance
- Processing and Process Equipment, and Production In-process Controls
Speaker
Barry A FriedmanCourse Provider
Barry A Friedman,
