Note: Provisional timetable, the actual schedule may vary depending on the situation.
Programme Day 1
09.00 - 09.15 h Welcome & Introduction
09.15 - 10.15 h
GMPs and QA Oversight for Packaging Operations
- GMP requirements in the packaging unit
- Important Guidelines and standards
- QA Systems relevant for packaging operations
- Frequent inspection findings
10.15 - 10.20 h Short Break
10.20 - 11.30 h
General GMP requirements for Packaging Operations / Key Compliance Challenges for Packaging Operations
- Handling and storage of packaging materials
- Testing
- Stability issues
- Material storage, returned goods, quarantine
- Line Clearance
- Documentation practice
- Practical GMP aspects
- Good and bad practice
11.30 - 11.45 h Break
Quality and Compliance systems in the Packaging Plant
- Hygiene and Zone Concepts
- Material flow
- Line clearance procedure
- IPCs in the packaging process
- Documentation and control
- Handling of variable printing data
12.30 - 13.00 h
Q&A Session 1
13.00 - 14.00 h Break
14.00 - 15.00 h
Packaging of Highly Potent Products / Q&A Dynamic Session on Packaging (Tips & Problems)
- Cross Contamination – how to avoid it:
- 1 – dedicated vs multi product facility
- 2 – production planning
- 3 – cleaning procedures
- 4 – people movement
15.30 - 15.30 h
Secondary Packaging (Interactive Session)
15.30 - 15.45 h Break
15.45 - 16.30 h
The Application of GxP in Packaging Supply
- Relevant ISO standards
- Introduction to British “GMP for Packaging Materials”: PS 9000:2016
16.30 - 17.00 h
Q&A Session 2
Programme Day 2
09.00 - 10.00 h
Packaging Facilities & Premises / GMP Design Aspects for Packaging Lines
- Requirements for the technical building equipment
- Zone Concepts for primary and secondary packaging
- Air-Lock concepts
- Hygiene
- HVAC
- Design criteria for blister machines, cartoners, labelers
- Differences to aseptic filling / packaging
- What is critical?
- What to write in an URS?
10.00 - 10.45 h
Reducing Risk through Supplier Auditing
- How much GMP must a supplier have?
- Practical audit aspects: what to examine?
- Qualification of suppliers
10.45 - 11.00 h
Qualification and Validation
- Equipment qualification
- Process validation
- Critical issues which have to be tested
- How to test?
11.45 - 12.15 h
Q&A Session 3
12.15 - 13.15 h Break
13.15 - 14.00 h
Serialization and Aggregation – How we implemented, what worked and what didn’t
- Challenges in the implementation phase
- Equipment qualification/ process validation
- Packaging material management
- Impact on the Supply Chain
- Handling of Failures / Deviations / Complaints
14.00 - 15.00 h
How to minimize Risk in Sterile Packaging
- What can go wrong in sterile packaging?
- How to minimize these incidents applying QRM principles.
- Aseptic filling and terminal sterilization:
- Microbiological quality of the primary packaging components
- Media Fill
- Container Closure Integrity (CCI)
15.00 - 15.05 h Short Break
15.05 - 15.30 h
Q&A Session 4