This FDA audit webinar will highlight the purpose of FDA audits and scope, Understanding of QSIT audit and how to develop an audit preparedness plan. It will also give understanding of what the FDA will look for at the conclusion of your audit and how to communicate with FDA before and after the audit.
Why Should You Attend:
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.Areas Covered in the Webinar:
- The purpose and scope of FDA audits
- FDA forms 482 and 483
- What exactly a QSIT audit entails and how to pass it
- How to 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
- Do's and Don'ts for your audit team
- Tips and tricks to ensure smooth audit experience
Who Will Benefit:
- Regulatory Professionals
- Quality Assurance Professional
- Executive Management
- Individuals involved with FDA compliance
Speaker
Joy McElroyCourse Provider
Joy McElroy,
