Skip to content

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

Project management,IT,Development


NetZealous LLC

Summary

Price
Save 82%
£29 inc VAT (was £170)
Offer ends 31 August 2021
Study method
Online, self-paced
Duration
2 hours
Access to content
6 months
Qualification
No formal qualification
Additional info
  • Tutor is available to students
  • Certificate of completion available and is included in the price

Add to basket or enquire

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

Currently there are no Q&As for this course. Be the first to ask a question.

Reviews

Currently there are no reviews for this course. Be the first to leave a review.

FAQs

What does study method mean?

Study method describes the format in which the course will be delivered. At reed.co.uk courses are delivered in a number of ways, including online courses, where the course content can be accessed online remotely, and classroom courses, where courses are delivered in person at a classroom venue.

What are CPD hours/points?

CPD stands for Continuing Professional Development. If you work in certain professions or for certain companies, your employer may require you to complete a number of CPD hours or points, per year. You can find a range of CPD courses on reed.co.uk, many of which can be completed online.

What is a ‘regulated qualification’?

A regulated qualification is delivered by a learning institution which is regulated by a government body. In England, the government body which regulates courses is Ofqual. Ofqual regulated qualifications sit on the Regulated Qualifications Framework (RQF), which can help students understand how different qualifications in different fields compare to each other. The framework also helps students to understand what qualifications they need to progress towards a higher learning goal, such as a university degree or equivalent higher education award.

What is an ‘endorsed’ course?

An endorsed course is a skills based course which has been checked over and approved by an independent awarding body. Endorsed courses are not regulated so do not result in a qualification - however, the student can usually purchase a certificate showing the awarding body’s logo if they wish. Certain awarding bodies - such as Quality Licence Scheme and TQUK - have developed endorsement schemes as a way to help students select the best skills based courses for them.