Efficient Batch Record Design and Review
Im Auftrag der ECA Academy

29-30 May 2018

Barcelona, Spain

Seminar Nr. 16259

Unser Seminarservice

Kosten

Die Veranstaltung hat bereits stattgefunden

Rückfragen unter:
Tel.: 06221 / 84 44 0 E-Mail: info@concept-heidelberg.de

Sprecher

Dr Bernhard Böhm, Boehringer Ingelheim

Jakub Cierný, SOTIO a.s.

Ingo Ebeling, Abbott Laboratories

Dr Monika Schlapp, Boehringer Ingelheim

Roger Smith, Redwood Pharma Consulting

Zielsetzung

During this course, you will learn 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.

Hintergrund

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.

Furthermore, many observations made in inspections
relate directly to the review of documents. This fact clearly demonstrates the importance and challenge of implementing a GMP/FDA-compliant Batch Record
Review.

During this Education Course, experts will cover all relevant aspects helping you to improve your batch records and their review.

Zielgruppe

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.

Workshops

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 optimize 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.

Programm

Regulatory Requirements applying to Batch Record

Review, Pharmaceutical Documentation & the Quality System
EU Regulations
FDA
ICH Q7 requirements
Regulations Update and Latest Developments in Industry
How documentation fits into the Quality System of recommendation 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

Steps to consider for a successful Batch Record Review Preparation

Line clearance
Process steps
Changes during the process
Deviations in production
Certificates of analysis

QA Oversight on EBR validation activities

Validation Life Cycle
Qualification activities
Maintenance
Training

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

Bringing it all together Session

How to structure reviews
Different assurance approaches in review
Responsibilities for review

Case Study: Electronic Batch Record (EBR) – a competitive Advantage?

Transition from paper based to EBR
Master approval
How efficient is an EBR system?
Challenges in the introduction phase
Electronic Batch Record Review

Two Case Studies on Operational Excellence: Tools to reduce Batch Record Review Time

Tools and philosophy
Batch record work stream reduction
How to successfully execute Kaizen events
Re-Design of batch records
Right first time project

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Efficient Batch Record Design and ReviewIm Auftrag der ECA Academy