Foreign Manufacturing Facilities – Avoiding Problems with FDA is a webinar that covers topics such as:
- Manufacturing in compliance with current good manufacturing practices (CGMP)
- Findings of adulteration and creating new drugs – and resulting injunctions
- Facilities and controls used for the manufacture, processing, packing, or holding of drugs
- Meeting the quality and purity characteristics required by FDA
- Keeping batch production and control records for each batch of drug product
- Equipment cleaning and record keeping
- Assessing the stability characteristics of drug products and determining appropriate drug storage conditions and expiration dates
- Investigating unexplained discrepancy or the failure of a batch of drug products
Foreign Manufacturing Facilities – Avoiding Problems with FDA brings together:
- Hazard Analysis Critical Control Point (HACCP) Coordinators
- Technical Directors / VP`s
- Pharmaceutical Quality Assurance Managers
- Pharmaceutical Operations / Production Managers
