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
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
Risk Assessment/ Management Applications within the Batch Record Process
- How the risk lifecycle links with the BRR stages:
- Risks associated with paper and electronic records
- Risks associated with people checking documentation
- Relative risk factors
- Risks associated with the process
- Risks for QP 'discretion'
- Quality Risk Management
- Impact the effectiveness of deviations, OOS and Change Controls
- Improvement of root cause investigations
- Using QRM to perform a SWOT analysis
- What does a good risk assessment look like?
Case Studies:
- Operational Excellence - Tools to reduce Batch Record Review Time
- Electronic Batch Record (EBR) – a competitive Advantage?
- Serialisation - from Master Batch Documentation to Batch Release
- Batch Record Design and Review in pharmaceutical Development
QA Oversight on EBR validation activities
- Validation Life Cycle
- Qualification activities
- Maintenance
- Training
Workshop:
Three parallel workshops will be conducted in order to deepen the content of the lectures and to discuss practical aspects in Detail.
Workshops will be offered on the following topics:
- Workshop 1: Deviation Management and Failure Investigation as Part of the Batch Record Review
- Workshop 2: How to optimise your Batch Record Review flow: The way from status quo to an ideal state
- Workshop 3: Design of a Master Batch Documentation/ Protocol
Each participant will have the opportunity to take part in 2 workshops! Please choose the ones you like to attend when you register for the course.