Part 1: Background and GMP Requirements
Regulatory Requirements applying to Batch Record Review, Pharmaceutical Documentation & the Quality System
- Global regulations and expectations
- Regulations update and latest developments in Industry
- How documentation fits into the Quality System of recommendations and regulations
- Important data for Quality Assurance
- Risk Assessment and Continuous Improvement
The Design of the Master Batch Documentation
- Is there a need for re-design?
- Important aspects to consider
- How to gain efficiency
Batch Record Design and Review in pharmaceutical Development (Case Study)
- Differences from the commercial batch records
- Expectations from batch record in development
- Different scenarios
Part 2: Practical Implementation
From the MBR Design to final Approval
- Creation of the Master Batch
- Generation of the batch documentation (who, what, how)
- The path through production.
- Review process (who, what, how)
- QP involvement
- Site kick: what if individual process steps take place at a third party
- Examples
Part 3: Possibilities for Process Improvement
Efficiency in Batch Record Review
- Layout and handling
- How to reduce review time: examples
- How to handle and document deviations
- How to present review results to the QP
- Balanced Score Card
- KPIs
Operational Excellence Tools to reduce Batch Record Review Time
- Background
- How to use Kaizen
- Project: “Batch record reduction / flow optimization”
Electronic Batch Record – A competitive Advantage?
- Legal background
- Minimum requirements
- What needs to be considered?
- Advantages
- Case Study
QA Oversight on EBR Validation Activities
- Validation Life Cycle
- Qualification activities
- Maintenance
- Training
Question and Answer Sessions
A set of live Q&A Sessions will give you the possibility to interact with the speakers and get answers to your Questions.