With the recent release of the FDA’s draft guidance “Responding to FDA Form 483 Observations at the Conclusion of a Drug cGMP Inspection,” expectations around audit responses are evolving, raising new questions for quality and regulatory professionals. In this webinar, Antiksha Joshi, Pharmaceutical QMS Consultant and Angel Buendía, Scilife’s Knowledge Manager, you’ ll explore not only how to respond to observations, but how to address the underlying system gaps that lead to them in the first place.
You will learn:
- Understand the key expectations outlined in the new FDA draft guidance on 483 responses.
- Navigate the audit process with a clearer view of the inspector’s mindset.
- Identify systemic issues that commonly lead to 483 observations.
- Strengthen your audit responses with practical, compliant strategies.
