Preparing for Regulatory Audits

Speaker

Instructor: Nick Campbell
Product ID: 701170

Location
  • Duration: 60 Min
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.
RECORDED TRAINING
Last Recorded Date: Apr-2009

 

$199.00
1 Person Unlimited viewing for 6 month info Recorded Link and Ref. material will be available in My CO Section
(For multiple locations contact Customer Care)

$350.00
Downloadable file is for usage in one location only. info Downloadable link along with the materials will be emailed within 2 business days
(For multiple locations contact Customer Care)

 

 

Customer Care

Fax: +1-650-362-2367

Email: [email protected]

Read Frequently Asked Questions

 

  • 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

Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
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. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).

 

 

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