ComplianceOnline

FDA Compliance and Quality inspections

Instructor: Sandra N. Whetstone
Product ID: 700513
Training Level: Intermediate
  • Duration: 60 Min

recorded version

$249.00
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
Last Recorded Date: Jul-2007

Training CD / USB Drive

$500.00
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

Email: customercare@complianceonline.com

Read Frequently Asked Questions

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.

Description

The Food and Drug Administration is using a new approach to inspections as a part of their cGMP Initiative for the 21st Century

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.

Follow us :
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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.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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