Live Online Training - Efficient Supplier Qualification

11 August 2020

Course No. 18137



Dr Georg Sindelar

Dr Georg Sindelar



During this Online Training, you will learn the most important aspects to implement and/ or improve a comprehensive and integrated Supplier Qualification System which fulfils regulatory GMP requirements. Furthermore, you will get to know possibilities and tools to increase efficiency and decrease costs at your company.


Qualification and audits of suppliers, contract manufacturers and laboratories and other service providers are an important part of each Quality System. But what is required and which steps are really necessary? And is it possible to even decrease audit activities?
Starting materials should only be purchased from approved suppliers. EU Directive 2004/27/EC states that the manufacturer shall only use active substances, which have been manufactured in accordance with the detailed guidelines on GMP for starting materials. But also in contract manufacture and analysis, the contract giver is responsible for assessing the legality, suitability and the competence of the contract acceptor to follow GMP (EU Guide to GMP [7.5]).
The requirements and efforts to qualify suppliers should therefore not be underestimated. However, it seems that a downright ‘audit tourism’ has grown and suppliers and service providers are audited on site frequently and sometimes too often. But supplier qualification is not limited to auditing. The whole process of supplier qualification and co-operation should be integrated in the existing Quality System of a company.

Target Group

This Online Training is designed for all personnel involved in supplier qualification activities at their company and decision makers who want to improve the existing process.

Technical Requirements

For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings. At 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.


Live Online Training - Efficient Supplier Qualification

Seminar Programme as PDF

09.00 – 09.15 h

09.15 – 10.10 h
Duties and Responsibilities
  • Regulatory background (EU, ICH, FDA)
  • Duties and responsibilities
  • Importing APIs into the EU
  • Remote Audits
10.10 – 10.30 h Break

10.30 – 11.30 h
Outsourcing to Contract Manufacturers and Laboratories
  • Points to consider
  • Which activities can be outsourced - and how
  • Outsourcing outside the EU
  • Validation – tasks and responsibilities
  • When things go wrong – problems and conflict solving
11.30 – 12.15 h
Efficient Supplier Qualification – A Risk-based Approach
  • What is risk?
  • Tools that could be used in the qualification process
  • Examples for risk assessments in supplier qualification
12.15 – 12.45 h
Live Q&A Session

12.45 – 14.00 h Break

14.00 – 14.45 h
Suppliers of Packaging Material and Excipients
  • Applying formalised Risk Assessments
  • Risk classification and Supplier Qualification
  • Solutions for audit request rejections
14.45 – 15.00 h Break

15.00 – 15-30
  • Different Types of Contracts
  • Parties and Signees
  • Staying compliant by staying up to date
15.30 – 16.00 h
Live Q&A Session


This course is part of the GMP Certification Programme "ECA Certified GMP Auditor" Learn more

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

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

Do you have any questions?

Please contact us:
Tel.: +49 6221 8444-0

Woman with headset

Go back

Testimonials about our courses and conferences

“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