FDA Compliance and Quality inspections

Speaker

Instructor: Sandra N. Whetstone
Product ID: 700513
Training Level: Intermediate

Location
  • Duration: 60 Min
This FDA quality inspection training will focus on FDA’s current thinking on cGMP requirements, including background information on FDA’s inspectional requirements under the Food, Drug and Cosmetic Act. The Food and Drug Administration is using a new approach to inspections as a part of their cGMP Initiative for the 21st Century
RECORDED TRAINING
Last Recorded Date: Jul-2007

 

$249.00
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)

$500.00
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]

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This presentation will focus on FDA’s current thinking on cGmp requirements, including background information on FDA’s inspectional requirements under the Food, Drug and Cosmetic Act, FDA’s inspectional procedures and process, what firms can do to facilitate and prepare for inspections, FDA’s new approach utilizing quality systems and current FDA 483 findings.

Areas Covered in the seminar:

  • Overview of FDA’s statutory inspectional obligation, new inspectional approach for the pharmaceutical industry
  • Background on FDA’s inspection authority
  • FDA’s inspectional procedures and process
  • How to prepare for the inspection
  • How to facilitate the inspection
  • What the inspection will cover
  • FDA’s New Inspectional Approach
  • Common GMP deficienceis and recent 483 findings

Who will benefit:

This webinar will provide valuable assistance to those firms and individuals who are regulated by the U.S. Food and Drug Administration and subjected to FDA inspections and oversight. The employees who will benefit include:<.p>

  • Management
  • Production Employees
  • Quality Control Managers and Personnel
  • Laboratory employees

Instructor Profile:

Sandra N. Whetstone, is a former (retired) US Food and Drug Administration (FDA) executive. She has more than 35 years of experience as a US Food and Drug official and is a recognized expert in US Food and Drug Law, the Public Health Service Act and related statues. Mrs. Whetstone is a co-founder and Managing Director of Comprehensive Compliance Solutions, LLC, a consulting company specializing in all aspects of FDA regulatory compliance matters relative to human and veterinary drugs, biologics, medical devices and foods. She has developed and presented cGMP training courses for various segments of the pharmaceutical industry.

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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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