Control Strategy Applications for Robust Manufacturing Processes

Why Should You Attend:

A successful validation program depends upon information and knowledge from product and process development. This knowledge and understanding serves as the basis for establishing an approach to the control of the manufacturing process that results in products with the desired quality attributes.

Any process design that is minimal, incomplete, lacks depth, method and/or rigor is risky business in terms of regulatory drawbacks, interrupted manufacturing operations and ultimately financial setbacks in term of company profits! Consequently, it is of utmost importance that time be put in thorough process design for product and process development (control strategy initiatives), so that the sustainable benefit of a well-designed process can be reaped for long term financial rewards and reputable status in industry based on compliance status.

The importance of establishing control strategy for processes via the understanding of the interactions between critical process parameters (CPPs) and critical quality attributes (CQAs) associated with biologics and pharmaceuticals manufacturing operations cannot be over-emphasized. The understanding of this interaction between CPPs and CQAs will subsequently facilitate the improvement of process knowledge and understanding, ultimately leading to better process control initiatives for robust manufacturing operations as well as better process validation design strategy.

Processes can be designed to easily identify any source of variation that can be promptly and efficiently corrected, subsequently minimizing waste or scraps in manufacturing processes (the FDA 2011 guideline on Process Validation). The webinar will also highlight on the 3 stages of process validation life cycle (process design, process qualification, continuous process verification) and their importance to successful and sustainable process validation program to satisfy regulatory body requirements.

Areas Covered in the Webinar:

• Process Design
• Process Qualification
• Equipment Qualification – IQ, OQ, PQ
• Continued Process Verification
• Critical Process Parameters
• Critical Quality Attributes
• Critical Material Attributes
• Process Validation

Who Will Benefit:

• R&D Scientists and/or Technicians
• Process Development Scientists / Technicians
• Technology Transfer Technologists
• Process Validation Technicians / Scientists
• Manufacturing Operation Managers/ Supervisors

From the following industries:

• Biologics, Pharmaceuticals, Vaccines, Medical Devices etc.

Free Materials:

• FDA 2011 Process Validation Guideline
• Technical Report # 60: Process Validation: Life Cycle Approach

Victor Olatundun
Management Consultant, Validant

Victor Olatundun is a pharmaceutical professional with 25 years expertise in the field of validation, technology transfer, management consulting and quality system remediation strategy in the biologics and pharmaceutical industry. He possesses strong leadership and management skills coupled with strong technical expertise, process knowledge and understanding in the field of validation and manufacturing operations. Additionally, he possesses both hands-on expertise and a strategic view of all aspects of the validation relating to process, cleaning, shipping and commissioning & qualification projects.

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