FDA Inspection Readiness: A Guide to Preparing for Success and Overcoming Remediation

It is uncertain when the FDA will resume normal inspection operations and begin Enforcement Audits and Pre-Approval Inspections, but we know the time is coming! Adverse findings during an FDA inspection can have catastrophic results to not only the department/team targeted by the findings, but also management and the overall company. Each and every associate within the organization is responsible for being compliant and having the skill and knowledge to properly interact with inspectors and manage the inspection process

Interested in learning more? Register today and join us for a live webinar!

Learning objectives of this Complimentary Live Webinar:

· Help you manage inspections efficiently and effectively.

· Best practices on how to avoid 483s and increased enforcement action(s).

· The FDA’s approach to inspections, focus areas, and what documents they will be asking for.

· How to present information about your quality system in the most competent and professional manner.

· How to identify those critical to compliance areas that must be properly addressed to ensure fully compliant and inspection ready operations.

About Insider Talks

Insider Talks is an open forum where our industry experts share their insights on timely topics. Pharmaceutical, biotechnology and medical device companies gain new ideas and perspectives to help tackle complex challenges and deliver on our higher purpose of improving the health and safety of patients