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Decontamination Process and the new Draft of the EU GMP Annex 1

The course reviews the new requirements and main differences to decontaminate Isolators, RABS and General Surfaces in Cleanrooms described in the new Draft of Annex 1 published in February 2020.

Online webinar - 16 June 2020


Course description:

This course begins by a short description of the content of this new draft GMPs Annex 1 and main hot topics. Following, the course focuses on a specific hot topic : Decontamination Process.

This Process is always difficult to manage and a clear vision of the new requirements described in this draft is particularly important. Indeed, although the general approach is always the same “to disinfect efficiency a surface, it’s essential to clean it before!”, the methods and the requirements to attain a low level of contaminants are different, depending the surfaces concerned!

The scope of this course is to focus about the Decontamination Process for the 4 chapters concerned :
- Chapter 4 Premises
- Chapter 5 Equipment,
- Chapter 6 Utilities
- Chapter 8 Production and specific technologies.

Some keywords are difficult to define and they must be clearified :
Washing/Cleaning/Detergent, Disinfection/Disinfecting Agent, Fumigation/Sporicidal Agent, Sterilization and Decontamination.
We will also explain the following Keypoints :
Decontamination of surfaces of equipment in contact with product versus General Surfaces in Cleanrooms, Decontmination of RABS and Isolator : Major Differences, Utilities : Decontamination of a storage system and a loop distribution of a purified or a WFI Water.

To finish, we’ll come back about the comparison between a Fumigation Process (e.g. vapour-phased Hydrogen Peroxide) and a sterilization process to manage the decontamination process of surfaces in contact direct with products and especially vibrating bowls of closure systems in an isolator.

Course program

  1. Introduction New Draft Annex 1 February 2020
  2. Decontamination Process : General Presentation of Chapters concerned in the Draft
    • Chapter 4 : Premises
    • Chapter 5 : Equipment
    • Chapter 6 : Utilities
    • Chapter 8 : Production and specific technologies
  3. Glossary : Definition of key words often misunderstood
    • Washing/Cleaning/Detergent
    • Disinfection/Disinfecting Agent
    • Fumigation/Sporicidal Agent
    • Sterilization
    • Decontamination
  4. Focus on the different Decontamination Processes and the new requirements of the Draft
    • Equipment in contact with product versus General Surfaces in Cleanrooms
    • RABS versus Isolator : Major Differences
    • Primary Container : Example of Glass Vials
    • Utilities : Storage System and Loop Distribution of a purified or a WFI Water
    • Fumigation (e.g. Vapour-phased Hydrogen Peroxide) versus Sterilization
  5. Questions and Answers

Who should attend:

  • Qualified Persons
  • Sterility Assurance Managers
  • Quality Directors
  • Qualification and validation Managers
  • Quality Control Managers
  • Production Managers
  • Teams responsible for Batch Release

 

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Course facts

Course no:
5818
Industry:
Medical Devices

Level:
Basic/Intermediate
CS region:
Global

Language:
English
Instructor:
Peter Knepell
Pierre Devaux
Theraxel

Date:
16 June 2020


Time:
14.00 - 15.30 CET (Central European Time)

Price (excl. local VAT):
250 Euro for the first participant.
115 Euro for the following participants on the same registration and invoice.
Course handouts (PDF) and certificate of attendance is included.
For larger groups, please contact us for an offer.


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 application "GoToWebinar".
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.