During this live Education Course, you will hear about all relevant aspects of the batch record flow from the master to the review. Furthermore, you will get to know possibilities and tools to increase efficiency and decrease costs at your company.
Background
The Batch Record Review is an essential tool for assuring the quality of a pharmaceutical process.
Various regulations and guidelines address this topic for the pharmaceutical industry and it is a very important step before a product can be certified by a Qualified Person. However, over the years, documentation has become more and more extensive and the review can be very time-consuming, also because of complex master documents.
Furthermore, many observations made in inspections relate directly to the review of batch records. This fact clearly demonstrates the importance and challenge of implementing a GMP/ FDA-compliant batch record design and review.
During this Education Course, experts will cover all relevant aspects helping you to improve your batch records and their review.
Target Group
This Education Course is designed for all persons in Production and Quality Units who deal with the design and review of batch documentation in pharmaceutical, biopharmaceutical and API production. It is also addressed to Qualified Persons who want to improve their system of the batch record review.
Presentations/Certificate
The presentations for this event will be available for you to download and print before and after the event. Please note that no printed materials will be handed out on site and that there will not be any opportunity to print the presentations on site.
After the event, you will automatically receive your certificate of participation.
Regulatory Requirements applying to Batch Record Review, Pharmaceutical Documentation & the Quality System
Part 1: Batch Record Review - Cost of Quality - Relevant GMP Guidelines: EU, US, ICH - Regulations update with impact on documentation - Documentation and FDA Warning Letters
Part 2: Pharmaceutical Documentation and the Quality System
- How batch documents fit into the Quality System - Important data for Quality Assurance - Risk Assessment and continuous improvement - The link to Operational Excellence and validated automated systems - Review Matrix - Possible structures
The Design of the Master Batch Documentation
Important aspects to consider
How to gain efficiency
Batch Record Design and Review in pharmaceutical Development (Case Studies)
Differences from the commercial batch records
Expectations from batch record in development
Different scenarios (stucture, deviation, changes, training, review process)
Part 2: Practical Implementation
From the MBR Design to final Approval (Presentation and Workshop)
MBR Design and Approval
Ways to optimise
Responsibilities
Paper-based vs electronical MB
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”
How wo optimise your Batch Record Review Flow (Presentation and Workshop)
The way from status quo to an ideal state
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
This course is part of the GMP Certification Programme "ECA Certified Quality Assurance Manager" Learn more
Testimonials
Seminar Programme as PDF