Learning from others' mistakes is a great approach to adopt when it comes to warning letters, which are among the most undesirable and unwelcome documents in the pharma industry. A warning letter is one of the agency's principal means of achieving prompt voluntary compliance with the Food, Drug, and Cosmetic Act. While the FDA generally determines violations through its own inspections, it can also issue a warning letter based on evidence from state personnel. But despite its disconsolate nature, a warning letter is a great source of information; trends of quality issues, and typical pitfalls your organisation can have on the road to compliance.
Dig into all that valuable information in this insightful webinar by industry expert Milind Nadgouda. Nadgouda will share how the information and trends that can be seen in the warning letters issued across different types of organizations give an insight into gaps within quality management systems, processes, and establishments.
After attending this webinar, you will benefit from a summarized data overview; trends, and an expert view point on what can be learnt from these; what to watch out for whilst preparing towards regulatory compliance and ensuring continuous quality.
This webinar will walk you through the following areas:
Who Should Attend
Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.
Milind Nadgouda is a seasoned quality and regulatory professional with 19 years of industry experience. He is the co-founder and director at RiverArk Limited, a quality consultancy providing services in the GxP space. His core areas of specialisation are risk strategy (identification, assessment, rating, prevention, and mitigation); regulatory agency inspection readiness, and quality management system GAP analysis.