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Trial Master File (TMF): FDA Expectations from Sponsors and Sites

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This training will review the essential elements of a TMF for clinical trials. The activities of set-up, maintenance, and monitoring will be discussed using case studies to highlight common deficiencies and potential solutions.

Speaker
Instructor: Mukesh Kumar
Product ID: 703078
Training Level: Intermediate to Advanced

Why Should You Attend:

If you are involved in a clinical trial, either as a clinical site or a sponsor, this webinar will provide valuable suggestions about which documents are essential and which ones are not needed for an FDA audit. The instructor will discuss common deficiencies identified by FDA auditors during review of TMFs and provide potential solutions to the same.

This webinar will also discuss issues related to the kind of products being tested, responsibilities of individuals, resources available, and projected trends for the near future.

Areas Covered in the Webinar:

Who Will Benefit:

This webinar will provide valuable information to people investing in FDA-regulated product development projects and also the following personnel:

Instructor Profile:

Dr. Mukesh Kumar is a Washington DC-based consultant in regulatory affairs and quality assurance for manufacturers and developers of FDA-regulated products. He leads the regulatory affairs and quality assurance departments at Amarex, a full service pharmaceutical product development company based in Germantown, MD. His key expertise is in regulatory affairs, clinical trials and multi-national project management for medicinal and diagnostic products. He has been involved in about more than 100 clinical trials in more than 40 countries, has made hundreds of US FDA submissions, and arranged a number of meetings with the US FDA. In addition, he has had made regulatory submission in the EU, Taiwan, Korea, China, Canada, countries in South America, Australia, and India. He has conducted GCP, GLP, GMP and GACP audits in the US and several countries in Europe, North and South Americas and Asia.

Dr. Kumar has conducted numerous training workshops in FDA compliance related issues. He has authored numerous articles in peer-reviewed journals. He is a well-known expert in global regulatory affairs and has been an invited speaker in several professional and academic organizations worldwide. Dr. Kumar is a PhD in Biochemistry and is a certified regulatory affairs professional by the Regulatory Affairs Professional Society, USA.

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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 only 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."
For substitution, please email editor@complianceonline.com or call +1-650-620-3937.

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Training Options Training Duration = 90 Min
Attend Live Online Training Only
September 30, Tuesday 10:00 AM PDT | 01:00 PM EDT
$199.00 One Dial-in One Attendee
$799.00 Group–Max. 10 Attendees/Location
(For multiple locations contact Customer Care)
$249.00 Access Recorded Version Only
One Person - Unlimited viewing for 6 Months
(For multiple licenses contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section 48 hrs after
completion of Live training
$449.00 Get Training CD Only
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 after
completion of Live training