Preparing for and Managing FDA Inspections

Speaker

Instructor: Jonathan M Lewis
Product ID: 703512

Location
  • Duration: 90 Min
This webinar will teach attendees how to prepare for, manage, and follow up on FDA inspections. It will discuss common pitfalls to avoid during an inspection.
RECORDED TRAINING
Last Recorded Date: Jun-2015

 

$279.00
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)

$449.00
1 USB is for usage in one location only. info CD/USB and Ref. material will be shipped within 15 business days
(For multiple locations contact Customer Care)

 

 

Customer Care

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Read Frequently Asked Questions

Why Should You Attend:

If you are looking for answers to these questions, you would certainly benefit by attending this seminar on managing FDA inspections:

  • How can your company be prepared for an FDA inspection?
  • How should your company respond to a 483 or warning letter correctly the first time without hiring a costly law firm?
  • What can an FDA inspector legally ask for during an inspection and what can you refuse to show the investigator?

Well, the answers to these and many, many more typical questions are now available in a simple to understand yet detailed training session designed to help manufacturers of FDA regulated products prepare for, manage, and follow up on inspections.

Areas Covered in the Webinar:

  • Define the steps necessary to prepare for an FDA inspection
  • Discuss details surrounding the management of inspections from announcement to close out meeting
  • Offer responses to FAQs regarding typical inspector requests during inspections
  • Define the methodology for responding to 483 and warning letters
  • Discuss common pitfalls to avoid during an inspection

Who Will Benefit:

This course will provide valuable assistance and guidance to all regulated companies (pharmaceutical, biopharmaceutical, biologics, medical device etc) that are preparing for FDA inspections. The following job titles/ positions will benefit from attending this seminar:

  • Internal Auditors
  • Regulators
  • Legal Departments
  • Compliance Officers
  • Validation Managers
  • QC Managers
  • QA Managers
  • Facilities and Engineering Department Staff
  • Compliance Consultants
  • Senior Management

Instructor Profile:

Jonathan M. Lewis, has over 22 years’ experience in the areas of quality control/quality assurance (QA/QC), manufacturing, regulatory affairs, validation, and project management in both industry and consulting roles. Mr. Lewis has experience in the medical device, diagnostic, biopharmaceutical, pharmaceutical, cosmetic, nutritional supplement, food, and animal feed industries.

Prior to founding Reliant FDA Experts (Reliant) (ABC), LLC, Jonathan worked for KMI/PAREXEL, a regulatory compliance and validation consulting firm, in increasing roles of responsibility from an entry-level Validation Engineer to an Associate Director of Consulting. He has worked at RPScherer (Cardinal Health), a contract and proprietary solid oral dose pharmaceutical manufacturing facility, as the QC/Validation Manager. In addition, he has worked at Telectronics Pacing Systems, a medical device manufacturer, in the Sterility Assurance Laboratory.

Topic Background:

Most federal laws concerning the FDA are part of the Food, Drug and Cosmetic Act which are codified in Title 21 of the United States Code. However, the language in the law and regulations is often very vague and difficult to interpret. Hence, FDA inspections often result in observations and compliance actions that cost manufacturers and marketers of FDA regulated products hundreds of hours and sometimes millions of dollars to address to the satisfaction of the agency.

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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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