Francois Vandeweyer
VDWcGMP Consulting
VDWcGMP Consulting
All times mentioned are CET
Seminar Programme as PDF
Conducting an Audit – Tools and Technical Aspects
CEFIC/APIC’s Activities and Working Groups –
APIC’s Third Party Audit Programme
Applying Quality Risk Management to prepare for an Audit
Audit Sessions
You will work on questions and case studies concerning these Topics.These audit sessions are supposed to be a Knowledge assessment. This assessment is only relevant
for participants intending to obtain the APIC Auditor Certification.
Conducting an Audit – Communication and Psychological Aspects
Training Objectives
Communication Part I
General Aspects of Communication
Key Issues of Communication
Conducting an Audit – Role Plays
The participants will have the opportunity to manage an audit situation within a role play scenario. During These role plays a trainer with academic education in psychology assesses the participants’ auditing skills and judges their aptitude for conducting audits. This assessment is relevant only for participants intending to obtain the APIC Auditor Certification.
Communication Part II
Multicultural Aspects
Audit: A unique Situation of Communication
Communication Part III
General Aspects of Opinions and Observations
Questioning Methods
Open-ended and closed-ended Questions
Other questioning techniques
Exercise
Attitude and behaviour in front of the auditee
Preparation for the Role Plays
The Audit Closing Meeting and Measuring Success
Lead auditor’s tasks and behaviour in the Closing Meeting
Audit summary Reports
Audit finding categories
Audit response and follow-up Audits
Ways to measure the success of an audit
Conducting an Audit - Remote or Onsite
During these sessions the speakers will explain the differences and commonalities of onsite and remote audits and will point out the advantages and disadvantages of each kind of audit set up.
Written Exam only for participants intending to obtain the APIC Auditor Certification
You will have to answer questions about GMP topics derived from ICH Q7 in a written exam. After having passed successfully this exam, you will be required to take another exam on current GMP topics as an internet-based multiple choice test, approximately 2 weeks after the course. The access code will be made available via email. After having passed this test successfully, you will receive the APIC Auditor Certification.
This course is part of the GMP Certification Programme "ECA Certified API Production Manager" Learn more
ECA-Member*: | € 2090,- |
Non ECA Member*: | € 2290,- |
EU/GMP Inspectorates*: | € 1145,- |
APIC Member Discount*: | € 2190,- |
(All prices excl. VAT). Important notes on sales tax.
Please contact us:
Tel.: +49 6221 8444-0
E-Mail: info@gmp-compliance.org