The GMP Auditor Initial and Continuous Professional Training for GMP Auditors

11-13 November 2015, Vienna, Austria

Course No. 9303

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Speakers

Dr Christian Hösch, GMP-Inspector, Ministry of Health and Consumer Protection, Hamburg, Germany
Afshin Hosseiny, Ph.D., Tabriz Consulting

Objectives

In this advanced training course you will learn
- How to plan and conduct audits efficiently
- How to face the various challenges
- What communication techniques are needed
- How you can avoid and solve conflicts

Background

Initial and continuous professional training for auditors and leadautitors is of utmost importance as the authorities expect highly qualified personal performing audits. Therefore the ECA has developed the programme at hand to give you a detailed overview about important matters to consider and to discuss important tasks and challenges like:
Expectations of the authorities
Audit types
Risk-based audit planning
Audit plan and audit team
Audits in China, India and South America
Categorisation of audit findings
Leadauditor skills and technical knowledge requirements
Communication Skills
Conflict solving

In a special Audit Simulation Workshop with role plays and video feedback, you will be able to broaden your skills and knowledge.

Please note: The number of participants is limited.

Target Group

New and experienced GMP-Auditors from Pharmaceutical and API Industry

Programme

How to optimise the Audit Programme
Community project: evaluation of supplier audits in Europe
Who needs to be audited
Things to consider when setting up a risk based audit programme
GMP Certificates and CEPs
Third Party, Joint- and Shared Audits
Expectations of the authorities
Examples: what can go wrong

How to plan an Audit
Setting out audit objectives
Selecting the audit team
Assigning objectives to the audit team
Performing audit and monitoring progress
Summarising findings and feedback to the auditee
Follow up and closing the loop

How to become a good Leadauditor
Auditor skills
Auditor technical knowledge requirements
Auditor training

Audit Types
Manufacturing site GMP audits
Wholesalers and distribution centres
Due diligence audits
Pre-inspection audits
Examples of audit findings

Suppliers from China, India and South America
How to prepare audits abroad
Challenges and pitfalls
Typical compliance issues: what to look for
Cultural particularities

Workshop:
Categorisation of various Audit Findings
Based on typical audit situations and real case studies, proposals on how to evaluate the given examples will be developed in small working groups. Possible follow-up activities will be discussed.

Interactive Sessions: Communication Skills
1. The challenge of appropriate communication
2. How to recognise, understand and solve conflicts
3. Body Language
4. Questioning Techniques

Audit Simulation Workshops:
Role plays
Video Feedback
Selected working groups will simulate pre-defined
audit situations. The experience and performance
will be evaluated and discussed with the team.

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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

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Further dates on-site
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Further dates online
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Recording
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Do you have any questions?

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

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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