ComplianceOnline

Preparing for Regulatory Audits

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

recorded version

$199.00
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

Training CD

$350.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-963-2556

Email: customercare@complianceonline.com

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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