GMP Certification Programme

Certified Quality Assurance Manager

Speakers

Deviation Management
Dr Martin M. Appel
Switzerland
and CAPA
01/02 June 2021 | Prague, Czech Republic

Marcus Heinbuch
B.Braun Melsungen AG, Germany

Dr Ulrich Herber
Charles River, Ireland

Mick Hopper
GxPpro, U.K.

Lea Joos
GMP/GDP Inspectorate, Germany Highlights
ƒ Rules and Regulations

ƒ Deviations and CAPA

- Classification
- Failure Investigation and Root Cause
- Risk Management
- Human Error

ƒ Case Studies:
- CAPA System Implementation
- Deviations in Microbiology
- Implementation of an electronic System

ƒ Evaluating and Monitoring

- Effectiveness of CAPAs
- KPIs
Workshops on:
- Process Analysis and Failure Investigation
- CAPA Effectiveness & System Performance Check
Programme

Objectives Programme
During this course, you will get to know the principles and dis- International Requirements – Rules and Regulations
cuss all relevant aspects to implement, improve and/ or work
with a Deviation Management and CAPA System. Furthermore, ƒ European requirements
you will get to know possibilities and tools to monitor and eval- ƒ e expectations of the FDA
Th
uate your CAPAs. ƒ GMP and documentation issues
ƒ Harmonisation in sight?
Background
Things will go wrong from time to time. In the world of pharma- Excerpt from FDA Warning Letter
ceuticals, we need to ensure that we have robust processes and “…the investigation failed to establish a root cause and
procedures in place to deal with such situations. When an un- your quality unit failed to ensure the implementation of
planned event arises it must be handled accordingly. adequate corrective actions to prevent future recurrence.”

FDA’s Quality System Guide, recent Warning Letters and EU-

GMP Chapter 1 clearly emphasise the increasing relevance of a Deviation Handling
proper deviation management and CAPAs. ICH Q9 on Quality
Risk Management and ICH Q10 on Pharmaceutical Quality Sys- ƒ How to document deviations
tems empower us to handle issues that arise in our daily work on ƒ I nformation and Data Management
the basis of risk analysis. ƒ Critical/ major/ minor
ƒ CAPA or not?
In any case a sound failure investigation is the key to identify
appropriate CAPAs. Here it is also important to know how to deal
with human error based and non-human error based non-con- CAPA: Principles, System, Implementation and
formances. Process Improvements and the use of Risk
Management Techniques
Independent from that, it needs to be pointed out that CAPA is
an excellent Quality Management tool to continuously improve ƒ Tools
processes and avoid future failures. All personnel involved in the ƒ uality Risk Management
Q
management of deviations and CAPAs should aim to identify op- ƒ Human Error Overview
portunities for further improvement. ƒ Monitoring & Evaluation Overview

Target Audience Workshop:

An interactive exercise on scenarios
This course is designed for all personnel involved in Deviation
with a focus on using the tools from the
Management and CAPA activities at their company. It is ad-
presentation
dressed to persons from Quality Assurance and Control, Manu-
facturing and R&D. ƒ H uman Error based
ƒ Non-human error based

Social Event Deviations in the Light of Inspections

In the evening of the first
course day, you are cordially ƒ F ocus in inspection
invited to a social event. ƒ Trends, Product Quality Review and Product Review
This is an excellent oppor- ƒ Self-inspection as an important tool
tunity to share your experi-
ences with colleagues from
other companies in a re- Case Study:
laxed atmosphere. How to implement a CAPA System

ƒ H ow to integrate existing QM Systems (OOS, Complaint

Handling, Deviations)
ƒ Examples and lessons learned

Deviation Management and CAPA | 01/02 June 2021, Prague, Czech Republic
 Speakers

Case Study: Speakers

How to deal with microbiological Deviations

ƒ Contamination control and company culture Dr Martin M. Appel

ƒ hat QA needs to understand
W Switzerland
ƒ Interface with QA and production
ƒ OOS vs. deviation in the microbiological laboratory Dr Appel was Director QA for the Global API External Manufac-
ƒ Possible CAPAs turing and Supplier Quality of Janssen Supply Chain. He has
more than 30 years experience in several manager positions in
the pharmaceutical industry.
Case Study:
Implementation of a Software Tool for CAPA
Management Marcus Heinbuch
B.Braun Melsungen AG, Germany
ƒ U nderstanding your workflows and processes
ƒ Can you improve the current process using electronic Marcus Heinbuch is Head of QM Operations in the Quality Man-
workflows? agement of CoE Pharmaceuticals.
ƒ Efficient validation of a CAPA application

Dr Ulrich Herber
CAPA Effectiveness & System Performance Check Charles River Microbial Solutions
International Ltd., Ireland
ƒ CAPA Effectiveness
- Why assessing effectiveness Dr Ulrich Herber is Director of Technology and Market Develop-
- The meaning of effectiveness ment - Microbial Solutions.
- Determine effectiveness
ƒ System Performance
- Performance Monitoring Michael Hopper
- Examples of Performance Indicators GxPpro, U.K.

Michael (Mick) Hopper set-up GxPpro after leaving Pfizer. Mick

has over 30 years experience and held several Technical, Man-
Workshop on CAPA Effectiveness & agement and QA roles.
System Performance Check
An interactive session with a focus on enhancing
the knowledge gained in the presentation. Lea Joos
GMP Inspectorate, Local Government
Munich, Germany

Lea Joos is a Pharmacist working for the local Inspectorate as

GMP and GDP Inspector.

GMP/GDP Certification Scheme

Building on your education the ECA GMP/GDP certification pro-

grammes provide you with the appropriate supplement to ac-
quire this qualification. Simply choose any three courses within
the programme according to your professional interest. Your cer-
tificate is then valid for two years. To renew it, you can pick any
training from the ECA courses and conferences list within that
two-years period – allowing you to broaden your knowledge in
GMP and GDP compliance.

Deviation Management and CAPA | 01/02 June 2021, Prague, Czech Republic
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