Quality Oversight in Sterile Manufacturing - Live Online Training

Wednesday, 6 November 2024 9 .00 - 17.15 h

Course No. 21417

header-image

Speakers

Dr. Bettina Rietz-Wolf

Dr. Bettina Rietz-Wolf

Regierungspräsidium Tübingen

Hans Steier

Hans Steier

Vetter Pharma-Fertigung

Dr. Florian Witte

Dr. Florian Witte

Boehringer Ingelheim

Heide Nagel

Heide Nagel

Novartis Pharma

Svenja Lacher

Svenja Lacher

F. Hoffmann-La Roche

Note: All times mentioned are CET.

Objectives

  • Learn about the US FDA‘s expectation of a Quality Oversight programme
  • Is Quality Oversight just an FDA expectation? What are the expectations of European Inspectors?
  • Quality Oversight; only a regulatory expectation? What advantages can you gain from the implementation for your own company?
  • How are Quality Oversight requirements implemented in sterile production? In 4 case studies, you will be presented with concepts and implementation Options

Background

In the „Guidance for Industry - Sterile Drug Products Produced by Aseptic Processing“ published in 2004, the FDA clearly formulated the expectations for Quality oversight. The aim should be to ensure regular and independent checks of the processes and personnel involved in aseptic manufacturing and thus reduce the risk of product contamination. In several warning letters in recent years, companies have been criticised for insufficient „quality oversight“.

In addition, against the background of new or revised European regulations, e.g. Annex 1 or Annex 15,

EU GMP Guide Annex 15 „1.3 ...However, there should be appropriate quality oversight over the whole validation life cycle“.

every European company faces the question of how the American demands for Quality Oversight will also be taken up in the regulatory environment here in the future.

Target Group

The Live Online Training is aimed at responsible employees in sterile production who are involved in the planning, establishment and implementation of a Quality Oversight programme in their companies. The following areas are specifically addressed
  • Production
  • Quality Assurance
  • Microbiology
Technical Requirements
For our Live Online Training Courses and Webinars, we use Cisco WebEx, one of the leading suppliers of online meetings. At https://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.

Programme

Quality Oversight and GMP in the EU
  • Overview of regulatory requirements in the EUƒ
  • The PQS (Pharmaceutical Quality System) as a Basisƒ
  • Requirements acc. to Annex 1
Expectations of an Inspector
 
FDA Guidance for Industry „Sterile Drug Products Produced by Aseptic Processing” (2004)
„Similarly, the quality control unit should provide regular oversight of adherence to established, written procedures and aseptic technique during manufacturing operations“.
 
Quality Oversight in Aseptic Manufacturing: FDA Expectation and Requirements
  • FDA regulatory requirementsƒ
  • Expectations regarding Quality Oversight: Requirements and Principlesƒ
  • ƒBackground for FDA Quality Oversight Requirementsƒ
Implementation of Quality Oversight: Case Study Boehringer Ingelheim. Opportunity forContinuous Improvement or Formal Compulsion?
  • Learn how to implement Quality Oversight efficiently by means of concrete examples
Case Study Vetter Pharma-Fertigung: Quality Oversight in Sterile Manufacturing
  • Establishing a Quality Oversight system at an CDMO in sterile manufacturing
  • FDA expectations and audit experiencesƒ
  • Interfaces to other Quality system
  • PIP - Person in the Plant Concept
  • Advantages and challenges
  • Regulatory outlook, Annex1 - Quality Oversight elements
Case Study Roche
  • Quality Oversight – Definition
  • Quality Oversight Strategy at Roche Kaiseraugst
  • Implementation of Quality Oversight at Roche Kaiseraugst
  • Prerequisites, opportunities and risk of Quality Oversight
Aseptic Operator Certification Programme in Sterile Production within the Scope of QA-Oversight
  • Training programme
  • Certification and Re-certification procedure
  • Training videos
Case Study Novartis: QA-Oversight in Sterile
  • QA Oversight concept
  • Training of QA-Oversight personnel (Train-the-Trainer)
  • Procedure in case of QA-Oversight observations

 

This training/webinar cannot be booked. Send us your inquiry by using the following contact form.

To find alternative dates for this training/webinar or similar events please see the complete list of all events.

For many training courses and webinars, there are also recordings you can order and watch any time. Just take a look at the complete list of all recordings.

* also payable by credit card
American Express Visa Mastercard

icon
Further dates on-site
Further dates on-site
Not available
icon
Further dates online
Further dates online
Not available
icon
Recording
Not available

Do you have any questions?

Please contact us:
Tel.: +49 6221 8444-0
E-Mail: info@gmp-compliance.org

Woman with headset

Go back

Testimonials about our courses and conferences

"Great material and speakers" and "Great speakers a lot of experience and sharing"

Felipe Gonzalez, Mucos Emulsionsgesellschaft mbH
Live Online Training - Granulation & Tableting, September 2024

"The lectures were very informative, interesting and entertaining."

Albert Godoy Hernández, Company synaffix
Live Online Training - GMP Auditor Practice, October 2024

"Really useful training which I will use in my daily work."

Regina Mommaerts, Galapagos NV
Live Online Training - GMP Auditor Practice, October 2024

"Wonderful format of the sessions: Good range of participations and experience in the team. Would love to attend another one soon."

Roopasi Mathi, Wacker Biotech B.V.
Live Online Training - GMP Auditor Practice, October 2024

"Very good balance between general and detailed information"

Dr Ralf Albrecht, Tillotts Pharma AG
Live Online Training - Granulation & Tableting
September 2024

"Nice presentations: easy understanding, quite visual"

Susana Manrique, Boehringer Ingelheim España, S.A,
Live Online Training - Granulation & Tableting, September 2024

“Fantastic course – I really enjoyed the interactive structure & greatly appreciate social activity.”

Anthony Cummins, Sebela Pharmaceuticals, Ireland
GMP Auditor Practice, September 2023

 

“Very well organized, information on point without being overwhelming.”

Eleni Kallinikou, Pharmathen
Live Online Trainng - Pharmaceutical Contracts - Febuary 2024

 

“Good overview of different types of agreements, good to see both the GMP and the legal angle”

Ann Michiels, Johnson&Johnson
Live Online Trainng - Pharmaceutical Contracts, Febuary 2024

 

 

“Well prepared presentations and good presenters. I also like the way of asking questions.”

Alexandra Weidler, Hookipa Biotech GmbH, Austria
Live Online Training – QP Education Course Module A, November 2023