James Blackwell, Ph.D., is Founder and a Principal Consultant for the Windshire Group, LLC, and Labshire, LLC, Dr. Blackwell has been a leading consultant to the regulated life science industry for almost two decades in the areas of CMC, process development, quality, laboratories, and manufacturing for all major therapeutic classes from pre-IND through commercial operations. He has been involved with third party consent decree monitoring, quality system remediation, and organizational quality mentoring for several multinational corporations.
This 20 hour course will help those involved with recombinant proteins and monoclonal antibodies (including fusion proteins, bispecific antibodies and antibody-drug conjugates), develop an effective risk-based Chemistry, Manufacturing & Control (CMC) regulatory compliance strategy for the manufacture and control of these products. The full spectrum of CMC, GMP and Quality activities across the pathway of clinical development will be applied to the unique requirements of these manufacturing processes and products. The critical importance of communicating CMC regulatory compliance strategy with the regulatory authorities at CMC-focused meetings will be stressed.
At the end of the three-day course attendees will:
Gain a solid understanding of the CMC regulatory compliance requirements and expectations (FDA, EMA, ICH, WHO) for recombinant proteins, monoclonal antibodies, and biosimilars, and understand why regulatory authorities treat biologics different than chemical drugs
Have the tools and understanding to develop and carry out an effective CMC regulatory compliance strategy for the company’s protein-based products
Understand the strengths and limitations of Quality by Design (QbD) – quality target product profile (QTPP), critical quality attributes (CQAs), critical process parameters (CPPs) and justification of the control strategy – and Quality Risk Management (QRM) for biologic manufacturing processes
Learn how to avoid major delays in clinical development or market approval due to an ineffective CMC regulatory compliance strategy
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