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Project management: GMP Expectations for Products Used in Early Phase IND Studies

Project management,IT,Development

NetZealous LLC

Summary

Price
£170 inc VAT
Or £56.67/mo. for 3 months...
Study method
Online
Duration
2 hours · Self-paced
Access to content
6 months
Qualification
No formal qualification
Certificates
  • Certificate of completion - Free
Additional info
  • Tutor is available to students

Overview

FDA issued a guidance document covering GMP requirements for Phase 1 products.

These guidelines remove some of the problems that are encountered with early phase products and are in addition to those that cover the CMC sections for IND submissions at Phase 1.

Although the guidance appears to remove the need to follow GMPs for Phase 1 products, the need to follow GMPs is still present in the Food, Drug, and Cosmetic Act. Thus the nature and extent of GMP-related activities will depend upon the nature of the investigational drug and the extent of the study that is planned.

Description

Areas Covered in the Session:

  • Discussion of the elements found in the guidance document for Phase 1 material
  • What to do at really early stages
  • What about special IND studies?
  • What about preclinical studies?
  • Varying GMP activities that depend upon the nature of the IND product
  • What are the requirements for the GMP found in the Food, Drug, and Cosmetic Act?
  • What to do about QC activities such as instrument qualification, method validation, and process validation

Who is this course for?

  • Regulatory Affairs Personnel who Coordinate Activities for the CMC Sections of Submissions
  • QA/QC Personnel who Need to Plan Work on Early Stage Material
  • R & D Personnel who Will Contribute data to CMC Sections
  • Project Managers for Product Development Studies
  • Quality Systems Auditors
  • Consultants

Questions and answers

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Certificates

Certificate of completion

Digital certificate - Included

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Legal information

This course is advertised on reed.co.uk by the Course Provider, whose terms and conditions apply. Purchases are made directly from the Course Provider, and as such, content and materials are supplied by the Course Provider directly. Reed is acting as agent and not reseller in relation to this course. Reed's only responsibility is to facilitate your payment for the course. It is your responsibility to review and agree to the Course Provider's terms and conditions and satisfy yourself as to the suitability of the course you intend to purchase. Reed will not have any responsibility for the content of the course and/or associated materials.

FAQs

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