In this FDA audit & Inspection training we will focus on ideas that will help identify areas of improvement before the formal inspection occurs. Further, you will learn techniques that will enhance your effectiveness during the audit execution.
Are you prepared for a surprise inspection?
Do your employees know how to conduct themselves during an audit?
Successful inspections require a well-thought out strategy and employees specifically trained on how to handle such inspections. This webinar will teach specific techniques to ensure their organizations are ready for regulatory inspections. We will focus on ideas that will help identify areas of improvement before the formal inspection occurs. Further, you will learn techniques that will enhance your effectiveness during the audit execution. We will also examine applicable warning letters and 483s so that your company doesn’t make the same mistakes as other organizations. By building compliance into every aspect of your operation, you can concentrate on getting more quality product out the door.
Are you prepared for a surprise inspection?
Do your employees know how to conduct themselves during an audit?
Successful inspections require a well-thought out strategy and employees specifically trained on how to handle such inspections. This webinar will teach specific techniques to ensure their organizations are ready for regulatory inspections. We will focus on ideas that will help identify areas of improvement before the formal inspection occurs. Further, you will learn techniques that will enhance your effectiveness during the audit execution. We will also examine applicable warning letters and 483s so that your company doesn’t make the same mistakes as other organizations. By building compliance into every aspect of your operation, you can concentrate on getting more quality product out the door.
Areas Covered in the seminar:
- Understand the basis for regulatory audits.
- Why regular inspections are necessary.
- How to establish your systems effectively so that you can defend your work practices.
- How to create a system of self-auditing that reduces the chances for FDA scrutiny.
- How to rehearse efficiently for regulatory audits.
Who Will Benefit:
This webinar will provide valuable assistance to all regulated companies, including companies in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:- Manufacturing and operations personnel
- QA managers and personnel
- Quality control personnel
- Facility maintenance and calibration personnel
- Logistics and supply personnel
- Any employee involved in regulatory audits
Course Provider
Nick Campbell,
