ComplianceOnline

How to Prepare for FDA GMP Inspections

Instructor: James Harris(PhD)
Product ID: 700990
  • 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: Aug-2008

Training CD

$500.00
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: +1-650-565-8542

Email: customercare@complianceonline.com

Read Frequently Asked Questions

This program outlines a system for preparing for an unexpected inspection and details SOPs that should be established in advance of the appearance of an inspector at your front door.

Description

This Webinar will provide valuable assistance to all regulated companies that face unscheduled inspections by regulatory agencies.

Only some GMP inspections (such as Pre-approval inspections) come with enough advance warning for us to be prepared. However, most such inspections come completely by surprise. Because of this, a system for hosting an inspection team and monitoring its activities must be established in advance of an inspection.

This program outlines a system for preparing for an unexpected inspection and details SOPs that should be established in advance of the appearance of the inspectors. In addition, key inspection topics that are the current "hot buttons" for the FDA will be reviewed; and approaches that will keep these points off your FD 483 will be identified.

Areas Covered in the seminar:

  • Identifying and training an inspection host team.
  • Rules to know and follow.
  • What to do when an FDA inspection team arrives.
  • How to manage a typical inspection.
  • Typical Points of FDA Interest.
  • The exit interview.
  • The FD 483.
  • Actions needed following the Fd 483.

Who Will Benefit:

This webinar will provide valuable assistance to all regulated companies that face unscheduled inspections by regulatory agencies. The program is specifically intended for companies that manufacture medical devices, diagnostics, pharmaceutical, and biologics products. Employees that will benefit include:

  • Quality control
  • Quality Assurance
  • Manufacturing
  • Technical service
  • Managers
  • Supervisors
  • Employees that could come into contact with inspection personnel.

Instructor Profile:

James R. Harris, PhD held VP level management positions in several of the world’s largest pharmaceutical firms before forming a consulting organization that worked globally serving pharmaceutical and related industries in over 60 countries.

Related Information: FDA GXP Compliance

The FDA initiatives "Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach" concerns the regulation of pharmaceutical manufacturing and product quality with an aim to focus GMP enforcement on high-risk products.
Read More on FDA GXP Compliance

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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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