Regulatory Inspections – How to Prepare for a Visit from an FDA Auditor
Duration : 60 Minutes
Denise Wrestler, ASQ CQE, CQA,
With over 15 years of experience
All medical device manufacturers that are FDA-registered will at some point be inspected by the FDA. Are you ready for when they come?
This presentation will cover how to best prepare for these inspections to ensure the process is as quick and seamless as possible. We will cover what they are required to ask for, what they will likely ask for, and how to ensure you provide information requested in a timely manner. We will also go over some tips and tricks that will also help in ensuring a smooth audit as well as how to respond to the FDA once the audit is complete. At the end of the presentation, I will answer any questions or concerns you may have regarding the FDA auditing process.
Course Objectives:
• Understand the purpose of FDA audits and their scope
• Understand what exactly a QSIT audit entails
• Develop an audit preparedness plan that you can use to execute the audit
• Understand what the FDA will look for at the conclusion of your audit
• Do’s and Don’ts on how to address FDA representatives
Course Outline:
• FDA forms 482 and 483
• FDA audit preparedness plans
• Review of QSIT method of auditing
• Do’s and Don’ts for your audit team
• Tips and tricks to ensure smooth audit experience
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
• Quality Assurance professionals
• Executive Management
• Individuals involved with FDA compliance
• Compliance officers
• Managers
• Manufacturing directors and supervisors
• Personnel new to the industry
• Pharmaceutical and cGMP auditors
• QA/QC personnel
• Regulatory/legislative affairs professionals
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
