Data Integrity and the Manufacturing Control Strategy for Life Sciences Manufacturers – What Should You Know About Implementing a Manufacturing Control Strategy?

In order to design a robust and flexible pharmaceutical production environment, you need interdisciplinary collaboration between different departments, including:

• QA/QC
• Process Development
• Manufacturing Operations
• Engineering
• Automation
• IT

As the Manufacturing Control Strategy initiative is relatively new, this webinar will reveal the new opportunities that arise from the implementation of a manufacturing control strategy and its best practice-based methodologies. The speaker will discuss best practice case studies, as well as, the enablers, elements and challenges of the production control strategy implementation.

A well-designed manufacturing control strategy enables the concept of “right first time,” data integrity, high performance and best practice-based processes.

Participants can expect to learn:

• Aspects of a manufacturing control strategy and considerations for how to approach a manufacturing control strategy implementation
• Benefits of manufacturing control strategy when it is designed in a cross-divisional approach

Background Information:

The ICH Guidelines define how to design the control strategy and to apply this for all products. The design of the manufacturing site and the manufacturing operations environment, as well as the production processes, is based on the ICH control strategy coming out of development.

The physical and operational design of the equipment, facilities, logistics and operations concept including work instructions, should be based on process maps and process data maps. This requires the early collaboration of all pharmaceutical departments to design a facility which is operating at a high-quality level, that is robust, flexible and right first time.

In turn, this requires the data integrity by design implementation principle to enable data integrity by applying a risk-based approach based on critical thinking. Future facilities will have a high level of automation.

Hurdles to Expect When Facing the Future of Pharmaceutical Production:

Current Regulatory Guidelines are in place to leverage these potential situations but examples to put them into practice are still missing. There is also an increasingly strong demand by regulatory authorities and Inspectors to apply the current requirements of risk management and safe production for life sciences products.

This is not just part of the next wave of hot topics but will lead to a paradigm change for the pharmaceutical manufacturers and product owners.

Register for this webinar and learn about one chance to overcome these burdens by evolving from a product control strategy to a manufacturing control strategy.

Speaker

Steve Murray, Principal Consultant, Werum IT Solutions America, Inc.

Steve Murray is a Principal Consultant with Werum IT Solutions America. In his role, he works with Life Sciences manufacturers to determine strategies related to MES deployment and methodologies for MES program management to optimize deployment and operational efficiency.  Steve has over 20 years of experience in delivering Level 2/3 systems to Life Sciences manufacturers in consulting, product marketing, and engineering roles. He has been responsible for the delivery of MES solution and integrated MES/DCS projects including integration techniques, system configuration, strategy, and delivery.

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