Master ADC Manufacturing Compliance with Wisdom's Expert Training
Training Schedule (18th, 19th & 20th November, 2024)
(18th November, 2024)
14:00 - 18:00 PM UK time
9:00 AM - 1:00 PM US EST time
(19th November, 2024)
14:00 - 18:00 PM UK time
9:00 AM - 1:00 PM US EST time
(20th November, 2024)
14:00 - 18:00 PM UK time
9:00 AM - 1:00 PM US EST time
Online
Join visionary speakers from leading organisations for crucial insights and expert opinions.
Dr. Len Pattenden, Managing Director, CMC Biopharma Ltd
Training Schedule (18th, 19th & 20th November, 2024)
14:00 - 18:00 PM UK time
9:00 AM - 1:00 PM US EST time
Technology transfer is a critical process in biopharmaceutical manufacturing, facilitating the transfer of processes, technologies, and knowledge between development and manufacturing sites. A robust technology transfer strategy is essential to ensure seamless transitions, maintain product quality, and accelerate time to market. This advanced training program offers a deep dive into the intricacies of technology transfer, covering key topics such as facility fit, equipment fit, regulatory compliance, risk management, and continuous improvement. Through a combination of theoretical learning and practical application, participants will emerge equipped with the knowledge and skills to excel in technology transfer projects and drive innovation in biopharmaceutical manufacturing.
Dr. Len Pattenden, Managing Director, CMC Biopharma Ltd
Len has over 30 years of experience in both industry and academia. Len has been a company founder, COO and GMP site head/license holder, overseeing biopharma development and manufacture as well as outsourced CDMO activities. Len has undertaken development and manufacturing of 18 new biological entities, including first-in-man/first-in-class cell and gene therapies, viral vectors, biologics, and monoclonal antibodies. Len’s regulatory and licensing experience covers the MHRA, EMA and FDA. Len works as a CMC consultant for small and large pharmaceutical companies. He is a member of a Regulatory working group, the ISPE and BIA
The training program will employ a combination of lectures, case studies, workshops, and interactive discussions to facilitate active learning and engagement. Participants will have ample opportunities to ask questions, share experiences, and apply theoretical concepts to real-world scenarios. The course will be delivered by seasoned industry expert with extensive experience in biopharmaceutical manufacturing and technology transfer.
Upon completion of the course, participants will:
This training program is essential for professionals involved in biopharmaceutical manufacturing, including:
Schedule:
DAY 1:
Session 1: Understanding the Landscape of Technology Transfer
14:00 - 15:00 UK Time (9:00 - 10:00 US EST Time) Title: Setting the Stage: Fundamentals of Technology Transfer in Biopharmaceutical Manufacturing
Summary:
Session 2: Facility and Equipment Fit for Technology Transfer
15:00 - 16:00 UK Time (10:00 - 11:00 US EST Time) Title: Ensuring Seamless Integration: Facility and Equipment Considerations in Technology Transfer
Summary:
16:00 - 16:15 UK (11:00 - 11:15 US EST Time) Time Coffee Break
Join visionary speakers from leading organisations for crucial insights and expert opinions.