Quality Practices for Research and Development (R&D) CMC Laboratories 2013

Key Topics

• What laboratory studies are required to be performed under GLP vs GMP?
• What is the economical impact of poor quality R&D CMC data in product development timelines and costs?
• What are the key-process related CMC activities
• What quality practices are expected for non-GMP/non-GLP laboratories where the data generated are used in regulatory filings?
• What is good CMC practices and how to ensure CMC quality is consistently implemented
• What are Key Analytical and QC CMC Activities

Who should Attend

• QA Managers and Auditors
• Laboratory Directors and Personnel
• Contract Industry and Academic Testing Facilties
• Regulatory Affairs CMC Specialists
• Project Managers with CMC Oversight
• Internal R&D Laboratories