PDA New England Chapter Event: Spring Dinner Meeting
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Please join us for this exciting event! Our expert guest speakers will be presenting on Phase-Appropriate Application of GMPs: Expert Perspectives with Case Studies. You will learn tips for conducting world class investigations and how to implement phase appropriate GMP quality systems.
This event will take place at the Four Points by Sheraton, Norwood, MA
*At this time we are accepting registration at the door only
Presentation Abstracts
James Blackwell: World class investigations are within reach of every organization and this talk will show you how. The business and compliance importance, and challenges of achieving excellence will be reviewed. Lessons learned apply to both clinical stage companies and multinational corporations. Insights will be gained into the most common mistakes and how to avoid them. Some of the most memorable investigations in Dr. Blackwell’s career and lessons learned will be shared along with a peek into the future of investigations.
Amnon Eylath : Amnon will present current industry thoughts on how to best implement phase appropriate GMP quality systems, practices and procedures, in alignment with international Health Authority expectations. Key concepts will be drawn from PDA Technical Report TR56 (Application of Phase Appropriate Quality Systems and GMP to the development of Biological API). Topics covered will be: The drivers and rationale for implementing Phase Appropriate GMP ; The partnership between PDA, Industry and FDA in developing and updating TR 56; The application of science and compliance-based thinking; Phase Appropriate Quality Systems and GMPs, as implementation of best practices for product development quality; The interaction and synergy between GMP and CMC • Phase Appropriate CMC and the Specification development timeline; What's next? Expanding TR 56 to include ATMPs.
Event Location
1125 Boston-Providence Turnpike, Norwood, MA 02062 Get DirectionsContact
Chapter Inquiries
Membership Services
At this time we are accepting registration at the door only.
Standard Registration
Member Price
$85.00StudentMember Only
$20.00
Non-Member
$155.00
Retired and Unemployed Members
Member Price
$20.00Day 1
6:00pm - 6:30pm | Reception & Networking
6:30pm - 7:00pm | Dinner
7:00pm - 9:00pm | Educational Presentations
Featured Presenters
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James Blackwell
Founder and a Principal Consultant, Windshire Group
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James Blackwell
Windshire Group
Dr. James Blackwell is one of the industries’ top experts in industry investigations. As Founder and a Principal Consultant for the Windshire Group, LLC, and Labshire, LLC., Dr. Blackwell has been a leading consultant 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 a consent decree and third-party monitoring, quality system remediation, and quality mentoring for several multinational corporations. Dr. Blackwell has held senior technical positions for leading companies and was head of site technical operations for the launch of Humira™. He has been on the founding management team of several start-ups. Dr. Blackwell’s accomplishments include working on some of the industry’s most innovative and important therapies and providing due diligence expertise for more than forty investment opportunities. James is a member of ISPE, PDA, AAPS, ISCT, and RAPS. He holds degrees in chemical engineering (Ph.D.), microbiology (M.S.), and dual business/technology management (M.B.A./M.S.). -
Amnon Eylath
Quality Leader, Alkeus
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Amnon Eylath
Alkeus
Mr. Eylath is a seasoned Quality Leader who is experienced in the complete life cycle of Small Molecule and Biological drug development: from discovery, through nonclinical and Tox studies, clinical trials, process and method development, GMP manufacturing, validation, regulatory submissions and US/EU/MHRA commercial product approvals. He has direct experience with process development, validation and QA/QC oversight for Cell Therapies and for therapeutic Monoclonal Antibodies and has led or supported cross-functional Continuous Improvement and Gap Remediation initiatives and projects. Mr. Eylath is an international thought-leader on Phase-Appropriate application of GMP to drug development and manufacturing and has presented seminars and training at PDA and ISPE events, as well as presenting on sterilization technology to CBER/CDER. He holds a lean-Six Sigma Black Belt (Amgen) and is Past President of the New England PDA chapter.
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