The Hitchhiker's Guide to 483s and Warning Letters

Description:

Regulatory Inspections are performed by various agencies to assure that anyone involved in the lifecycle of a pharmaceutical / biotech / medical device product, abides by the laws and regulations. This affects the entire supply chain.

Audits by the FDA are perhaps the most intimidating of all events at a regulated facility. Each year, the FDA conducts several thousand audits, approximately half of which lead to findings that result in Form 483s. Most Form 483 audits are amicably resolved, but a few lead to serious consequences for the audited parties, starting with Warning Letters and ending with heavy fines and jail time for a few. This webinar, will assist you in responding to a 483 or Warning Letter so the consequences of the findings do not escalate beyond the current status.

Objectives of the Presentation:

• FDA Inspections - background
• Causes of Form 483 / Warning Letter
• Some recent results of companies failing to respond appropriately
• Best Practices for Responding to 483
• Best Practices for Responding to Warning Letter
• What to do if the responses fail

Who can Benefit:

• CEO
• Regulatory VP
• Quality VPs
• IT VPs
• Regulatory Affairs Professionals
• Quality Managers
• Quality Engineers
• Small Business Owners
• GxP
• Consultants

Live Session - How it works

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Recorded Session - How it works

• Once you purchase a webinar you will receive username and password at your email address.
• Use the login details to view recorded webinars.
• Presentation handouts will also be shared in pdf format.
• Access to the recording is valid only till 6 months starting from the date of purchase.
• Get certification of attendance.