There is more going on in the validation and GMP environments than ever before. It has never been more critical to understand current regulations, trends and procedures such as statistics in validation, validating data and quality metrics. This conference, which took place March 15-16 in Puerto Rico, covers the implementation procedures for equipment, utilities, cleaning, computer systems, analytical procedures, as well as other critical GMP topics such as change control, risk management and corrective action, enterprise-wide. Non-compliance and poor validation and GMP processes cost patient safety and efficacy, product time-to-market, personnel time and millions in fines and revenue. Our compendium is a practical tool to aid you in avoiding these pitfalls. View the entire agenda here.
Professionals Working in the GMP and Validation Environments met to:
- Understand FDA’s Quality Metrics Draft Guidance
- Learn how to use statistics in validation
- Maintain a robust cleaning and computer/software programs
- Develop a Validation Master Plan (VMP) in critical environments
- Conduct a gap analysis of your validation and GMP programs