Starting materials – the GMP essentials

An overview of GMP requirements for starting materials – APIs and excipients

WEBINAR

Get the essentials of starting material requirements in GMP during this informative webinar. Both EU GMP requirements and US FDA requirements for APIs and excipients will be covered.

This is an independent continuation to the webinar “How to Qualify your suppliers in compliance with GMP” (11 Nov)

Course description

Regardless of the level of controls that have been applied on starting material suppliers, there are certain general GMP requirements that always needs to be in-place for each incoming lot of material.

This webinar contains a walk-through of the GMP requirements related to material specifications, minimal requirements for incoming controls and testing, aspects to consider related to Certificate of Analysis as well as requirements related to sampling.

Course outline

  • Specifications for starting materials as required in GMP
  • Necessary checks upon receipt
  • Testing – what must be done and when can a Certificate of Analysis be used
  • “Validation” of the Certificate of Analysis
  • Sampling

Learning objectives

  • Understand the different GMP requirements related to starting materials
  • Discuss the necessary incoming controls
  • Understand the basis for a reliable Certificate of Analysis
  • Get insight in requirements and challenges related to sampling

Who should attend

This course is intended for professionals who are responsible for incoming starting materials from a GMP perspective. Purchasing and Quality professionals will benefit by learning the relevant requirements and how they relate to supplier controls.

Prerequisites

#5825

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Date & Time
November 18, 2020
- November 18, 2020
10.00 - 11.30 CET
IndustryPharmaceuticals
LanguageEnglish
LevelIntermediate
LocationWebinar
RegionEU/US

250,00

No. persons
Discount:
3 persons or more 15% if registered and invoiced together for the same course.

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In-House Training

This course is available as an In-House Training course. Let us know if you wish to customize a course or if you are a large group with the same requirements.

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Your Instructor(s)

Leading specialist with long experience of training are guiding you through regulations, guidelines, interpretations, requirements and applications.

Anna Lundén

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