Win-Win FDA Inspections


Instructor: James Harris(PhD)
Product ID: 701482
Training Level: Intermediate to Advanced

  • Duration: 70 Min
This FDA Inspection training will present the information needed to prepare for an inspection and will discuss critical points with suggestions as to how they should be handled.
Last Recorded Date: Oct-2009


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Downloadable file is for usage in one location only. info Downloadable link along with the materials will be emailed within 2 business days
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Customer Care

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Read Frequently Asked Questions

Why Should You Attend:
We know when some GMP inspections such as Pre-approval inspections, will be conducted. 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 an inspector at your front door. In addition, key inspection topics that are the current "hot buttons" for FDA will be reviewed and approaches that will keep these points off your FD 483 will be identified.

A successful FDA inspection requires preparation including pre-assigning the personnel who will be involved, training them, and having dress rehearsals so that all activities on the part of the manufacturer's personnel is performed correctly and naturally. This webinar presents the information needed to prepare for an inspection and will discuss some of the more critical points with suggestions as to how they should be handled.

Areas Covered in the seminar:
  • How many company personnel should be prepared and what duties should each team member have.
  • How to greet the FDA inspector(s).
  • Basic rules for conducting the inspection.
  • Instructions for non-team members.
  • In-house communications.
  • The FD-483.
  • Post inspection requirements.

Who Will Benefit:
  • QA & QC managers and staff members
  • Manufacturing managers and staff
  • Senior corporate managers
  • Technical services
  • Engineering managers and staff

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.

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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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