Conference: GMP Compliance Trends in Analytical Laboratories/Outsourcing in Pharmaceutical Laboratories

Background & Objectives

It is the aim of this course to address GMP compliance issues that are currently discussed as hot topics in analytical quality control laboratories and during GMP-/FDA-Inspections.

Furthermore, this conference will highlight the wide range of regulatory requirements and practical aspects that need to be considered when testing on a contract basis. The conference in particular addresses topics that are relevant from a GMP point of view.

Due to changing regulatory requirements, pharmaceutical quality control units are continuously facing new challenges. There are many regulatory requirements relevant for the pharmaceutical quality control, both in EU and in the US. Laboratory Managers and Analytical Scientists must be familiar with the different GMP-related topics and must be aware of the latest updates and the current interpretation.

Outsourcing is one of the critical process in the pharmaceutical industry. According to the EU GMP Guidelines (Chapter 7 – Outsourced Activities) “any activity covered by the GMP Guide that is outsourced should be appropriately defined, agreed and controlled in order to avoid misunderstandings which could result in a product or operation of unsatisfactory quality. There must be a written Contract between the Contract Giver and the Contract Acceptor which clearly establishes the duties of each party. The Quality Management System of the Contract Giver must clearly state the way that the Qualified
Person certifying each batch of product for release exercises his full responsibility.”

There are various reasons for outsourcing analytic testing. Tests are sometimes outsourced only for specific projects. However, the analyses are sometimes conducted externally for each batch of a product in routine quality control, for example if the manufacturer does not have the necessary know how or the required capacity.

This conference therefore deals with the following topics:

• Data Integrity
• Regulatory and legal requirements
• Business Continuity
• Selection and management of partners
• Practical aspects to consider when establishing contracts
• Auditing contract laboratories

 

Target Audience

This conference will be of significant value to

• Laboratory managers, supervisors and analysts
• Quality control managers
• Heads of quality control
• Qualified Persons (QPs)
• Analytical scientists
• Senior laboratory staff
• Responsible authorities

This conference is also intended for employees in Quality Assurance and from contract laboratories. Furthermore, it is useful for service providers, such as contract research organisations and contract manufacturers.

Programme

Key Note: The Impact on the Revised Annex 1 for Rapid Microbiological Methods Implementation
Dr Michael Miller

Data Integrity and Cloud Computing in GMP Compliant Laboratories – Presence, Future or a Contradiction? A Perspective from the Eyes of a GxP Auditor
Dr Timo Kretzschmar, Inosolve

Business Continuity in cGMP
Alexander Pfülb, Labor LS

Shelf Life of Reagents in a Chemical-pharmaceutical Laboratory
Dr Jochen Kolb, BioChem

Understanding & preventing Human Errors
Dr Karl-Heinz Bauer, Boehringer

Lot Release and WHO Prequalification
Alya Aldahash, SFDA

Transfer to External Partners - Overcoming Pitfalls in Analytical Method Transfers
Dr Holger Bauer, Merck

Case Study: Technologies that make Lab of the Future and drive Collaborative Innovation
Lukasz Paciorkowski, A4BBE