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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. |
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| 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 |