How to Prepare For and Conduct a Regulatory Audit At Your Site
Duration : 60 Minutes
Alan Golden,
Alan has over 30 years of experience in the medical device industry, both in basic research and in quality assurance. Alan spent 31 years at Abbott Laboratories. For the first 16 years as part of diagnostics R&D, he developed recombinant proteins used in diagnostics tests, received three US pa Read more
Having a regulatory audit at your site can be one of the most stressful and consequential events your company can experience. This is especially true if you are not prepared and appropriately staffed for the audit.
Regulatory audits are the result of several factors. Your site may have routine annual compliance audits to maintain the ability to continue to manufacture/sell regulated products in a certain market. These audits are normally not product specific and focus on the overall quality system and manufacturing controls at your site. Another trigger for a regulatory audit might be pre-approval of a new product you wish to bring to market. These audits are normally focused on the product in question. A third type of audit would be your desire to market an existing product into a new regulatory market. Finally, there are audits or cause. This is where a regulatory body comes in normally due to a product issue in the field.
How you handle and conduct the audit can have an enormous impact on the outcome of the audit. A smoothly run, well organized response to the audit can result in a shorter audit, less disruption to regular business and a more favorable outcome.
Course Objectives:
• How to prepare for an audit and stay prepared (audit ready)
• Strategies to host a successful audit
• Ways to respond to any audit observations
Course Outline:
I. Preparing for a third-party audit or inspection
a. Assembly of an audit team
b. Prestaging of documents and records
c. Preparing “back room”
II. Conducting the audit
a. Required staff
b. Opening meeting
c. Tours
d. Notes and communication
III. Responding to audit findings
a. Response team
b. How fast
c. Next steps
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
The following professionals in the Pharmaceutical, Medical Device, or Combination Product industries with responsibilities in the following areas:
• Quality Systems
• Quality Assurance
• Quality Control
• Change Control
• Engineering/R&D
• Regulatory Affairs
• Validation
• Auditors
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
100% MONEY BACK GUARANTEED
Refund / Cancellation policyGet In Touch
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