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Medical Device equipment

Starting materials – the GMP essentials

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

WEBINAR - 18 November

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

 

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Course facts

Course no:
5825
Industry:
Pharmaceuticals

Level:
Intermediate
CS/GMP region:
EU/US

Language:
English
Instructor:

Anna Lundén

Date:
18 November 2020, Online


Time:
10.00 - 11.30 CET (Central European Time)

Price (excl. local VAT):
250 Euro
Course handouts (PDF) and certificate of attendance is included.


Discounts:
For groups registered and invoiced together for the same course we offer the following quantity discount:
3 persons or more 15%
We do not offer or practice any general company discounts without commitments and/or written agreements.


Equipment needed:
You need access to a computer, tablet or mobile phone with internet connection (preferably min 1MBit/s) and audio capabilities (speakers or headphones).
We are using the easy-to-use applications "GoToWebinar" and "GoToMeeting".
See more about how to join a session and the system requirements here »

Instructions will be attached to your order confirmation.


Cancellation policy for webinars:
Cancellations received less than 7 days before the webinar will be charged 50% of the course fee.
Cancellations received less than 24h before the webinar will be charged 100% of the course fee.

If you for any reason is unable to attend, substitution is always possible and preferred. All cancellations and/or substitutions must have been communicated with and confirmed by us.

In case of failure to cancel before the course, the course fee will be charged in full.


Cancellation of webinars:
Courses may be cancelled by the organizer if bookings fail to reach minimum numbers. In such circumstances charged course fees will be refunded, credited, or granted to attend another course for the same value.