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SCOPE

Utilising extensive knowledge of ICH guidelines, this course will outline and define best practice in the approach and requirements for Process Characterisation and Qualification (Validation) studies, with high quality manufactured product and final Regulatory submission, as an end goal.

This 2 day course, will define outcomes of Process Characterisation and Qualification (Validation) studies, address why they are needed, and describe how to effectively communicate data and findings to relevant Regulatory Authorities. With best practice in mind, the subject matter expert will use their extensive knowledge to help you align your process with Regulatory expectations.

Through interactive lectures and group discussion, you will learn why Process Characterisation data is critical to developing an understanding of the process as a whole, and how it can be used to introduce a process control strategy. You will also look at how to undertake process performance qualification (process validation), with study content encompassing a suitable approach, necessary documentation and importantly, addresses how to avoid potential sources of failure.

With quality as an inherent backdrop to successful biopharma product manufacture, the course will conclude with showing you how to employ data gathered from these studies, to implement continuous process verification; a third stage in the qualification/validation cycle.

Although ‘stand-alone’ in nature, this course is an invaluable follow-on from Quality by Design Process Development for Biopharma Products and can also be tailored and run as an in-house course at your site.

SUITABILITY

This in-depth course is suitable for biopharmaceutical professionals within the disciplines of Quality Assurance, Manufacturing, Regulatory, Process Design, Validation, Clinical Trials and Quality Control.

By the end of the course you will:

• Have an excellent understanding of the needs and expectations of process performance qualification (validation) studies and how to conduct these studies with the end product in mind.
• Gain the knowledge of how to develop and utilise process control strategies, and how to conduct continuous process verification.
• Acquire an understanding of the relevant Regulatory guidance associated with these activities and how to communicate them in terms of Regulatory submissions.