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.Agenda
- 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 Should Attend
- Quality Assurance
- Quality Control
- Microbiology/Analytical
- R&D Development
- Technical Services
- Validation
- Project Management
- Plant Management
