Training for Auditors

GMP in-house Training Courses are an ideal solution for ten or more people and are very cost-effective. We come to you at a time and date to suit your organisation.

Please contact us if you are interested in a detailed offer.

The agenda proposal aside has been developed for an in-house training course (group of participants). If you are interested to participate as an individual person please check our list of GMP training courses and conferences.

Agenda Proposal

The auditor in the pharmaceutical industry should have lots of skills: from the basics of an audit to the detailed technical knowledge he/she is expected to demonstrate in the different areas (classical chemical APIs, biological APIs, the manifold dosage forms – solids, liquids, terminally sterilized or aseptically filled items, the supporting technical services, HVAC, IT systems, Data Integrity, etc.). This course will provide insights to most of the technical areas and highlight critical process steps, which should be covered during the audit. The course is designed for internal and external auditors.

  Content Day 1
09.00 - 09.30 Introduction / Expectation of the Participants / Aim of the Event
09.30 - 10.45 Audit Scene Setting
Audits and the Quality System, Different Types of Audit
10.45 - 11.00 Morning coffee
11.00 -12.00 PIC/S, EU, FDA Audit Standards and Procedures
12.00 - 13.00 Lunch break
13.15 - 14.15 Auditor Competencies and Roles
Teamwork-What Makes a Good Auditor?
14.15 - 15.00 Communication Skills
Cultural Differences and Body Language
15.00 - 15.15 Short Coffee Break
15.15 - 16.15 Developing and Using Aide-Memoires and Checklists
Useful Techniques and Advice
16.15 - 17.00 Teamwork: Delegates Evaluate Their Auditing Skills
 
  Content Day 2
08.30 - 10.00 The Detailed Planning of the Audit
The Introductory Meeting

Teamwork: Gathering Information
Teamwork: Selecting the Team
Teamwork: Create an Audit Plan
10.00 - 10.45 Writing Audit Observations
Audit report/observation writing skills (best practices)
10.45 - 11.00 Morning Coffee
11.00 - 12.00 The Close-Out Meeting
Preparation for Close-Out Meeting
12.00 - 13.00 Lunch
13.00 - 13.45 Audit Follow Up
CAPA, Confirmatory evidence
13.45 - 14.15 Auditing the QMS
Deviations, CAPA
14.15 - 15.00 Hygiene / Personnel Hygiene
What is key?
15.00 - 15.30 Premises / Production
15.30 - 15.45 Coffee Break
15.45 - 16.30 Audit of IT systems
16.30 - 17.00 Q & A, discussion

 

  Content Day 3
08.30 - 09.30 Process Validation (and Computer Validation, Cleaning Validation and Validation of Analytical Methods)
09.30 - 10.30 Qualification/Calibration/Maintenance Compliance for technical documentation
10.30 - 11.00 Coffee break
11.00 - 12.00 Materials Management Audit Packaging / Storage / Transportation / GDP
12.00 - 12.30 Audit Data Integrity – audit processes to assess data integrity
12.30 - 13.30 Lunch
13.30 - 14.30 OOS (Out of Specification), OOE, OOT The Annual Product Review (PQR)
14.30 - 15.00 Compliance for APIs manufactured by Chemical Synthesis
15.00 - 15.45 Compliance for APIs manufactured by Cell Culture/Fermentation
15.45 - 16.30 Compliance for sterile production, Validation in the sterile area
16.30 - 17.00 Summary & Open Questions

 

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