Thursday, 05 September 2019
9:00
Welcome and Collection of Participant Expectations
9:30
Introductional Test about Selected Hot Topics in Aseptic Processing
10:30
Coffee Break
11:00
Important Aspects of Sterilization, Cleaning and Disinfection, Gowning Procedures
- Steam & Dry Heat Sterilization
- Moist Heat sterilization (Fo- Concept)
- Dry Heat Depyrogenation
- What can go wrong and common Audit findings
- Following PDA TRs are briefly addressed:
- Technical Report 1 (TR 1) / TR 3 / TR 48 / TR 61
- Key elements for Cleaning & Disinfection in cleanrooms
- Procedures and Best Practices
- Common mistakes and audit finding
- TR 70 Fundamentals of Cleaning and Disinfection Programs for Aseptic Manufacturing
- Gowning steps for entering grade A/B area
- Teamwork
- Important points to consider
12:30
Lunch Break
13:30
Important Aspects of Sterilization, Cleaning and Disinfection, Gowning Procedures (cont.)
14:30
Team Excercise 1: How to Build Up a New Aseptic Filling Line
15:30
Coffee Break
16:00
Aspects of Clean Room Concepts and Good Aseptic Working Practices
- Conventional filling lines
- RABS systems and isolators
- Understanding First Air and barrier concepts
- TR 62 Recommended Practices for Manual Aseptic Processes
- Points to Consider for Aseptic Processing: Part 1 & Part 2
- Update on new PDA TR Points to Consider for Isolators
17:30
End of Day 1
Friday, 06 September 2019
9:00
Best Practices in Aseptic Processing Simulation
- Basic Concepts and Regulatory Framework about Process Simulations
- Best Practices in Media Fills for Finished Dosage Form and API
- TR 22 Process Simulation for Aseptically Filled Products
- (Re)Qualification of Operators
- Categorization of Interventions
10:00
Effective Oversight at the Shop Floor, Good Training Methods
- Regulatory requirements and framework
- Sharing my best practices and effectiveness
- Examples from the shop floor worldwide
10:30
Coffee Break
11:00
Important Aspects in Environmental Monitoring
- TR 13 Fundamentals of an Environmental Monitoring Program
- Regulatory requirements and expectations
- Rationale for sample locations and frequency
11:30
Team Exercise 2: Set-up a EM Program for Cleanrooms/Isolators
12:30
Lunch Break
13:30
Team Exercise 3: Share your own case studies and problems, and find resolutions as a team
15:00
Coffee Break
15:30
Team Exercise 4: Benchmarking between team members
16:30
End of Course