Preparing for Regulatory Audits

Instructor: Nick Campbell
Product ID: 701170
  • Duration: 60 Min

recorded version

1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Apr-2009

Training CD / USB Drive

One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-362-2367


Read Frequently Asked Questions

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.

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

Instructor Profile:

Nick Campbell, is the founder of Sunriver Risk Management, a consulting firm that specializes in compliance training for the bioscience industry. He has spent his 20-year career working in operations for highly regulated industries, including the last 15 years in the pharmaceutical, medical device, and biotechnology sectors. His skills include a high level of proficiency in process engineering and facility operations. He has been instrumental in numerous regulatory audits including FDA, European Union, and Health Canada.

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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

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