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
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?
- 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
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.