INTERPHEX recently announced that they have confirmed two
FDA panelists for their educational conference.
Francis Godwin, FDA Compliance Officer will be presenting
the FDA’s views on continuous manufacturing during his session: Continuous
Manufacturing, a Regulatory Perspective on Tuesday, March 29th at 10 am.
As the pharmaceutical and biotechnology industries
increase utilization of continuous manufacturing, questions have arisen
regarding the regulatory implications of implementing these technologies. FDA
supports continuous manufacturing, and to facilitate use of new technologies
and continuous improvement, Godwin will discuss the following topics in regards
to continuous manufacturing: (1) Advantages/Disadvantages, (2) Importance of
upfront design, (3) Role of process control, (4) Sampling considerations, (5)
Related PAT principles, (6) CGMP regulations, and (7) Process validation.
Also on Tuesday, Dr. Steven Wolfgang, who leads a Data
Analysis Team at the FDA Center for Drug Evaluation and Research, in the Office
of Compliance’s Division of Manufacturing and Product Quality, will participate
in a panel discussion title: Leveraging Technology to Ensure Raw Material
Supply Chain Security in the Pharmaceutical Industry
This educational session will provide an overview of one
of the largest threats facing the pharmaceutical industry today, the risk of
adulterated materials, and what industry is doing to address this risk and
protect patients. The session will provide the latest understandings and
expectations from FDA on this subject. The session features a specific case
study from both an equipment provider’s perspective and a user’s perspective
where high tech analytical equipment, Nuclear Magnetic Resonance (NMR), was
introduced to QC operations. NMR is a powerful detection tool being employed to
detect potential adulterated materials and prevent their use in production.
In addition, the session will provide an overview of
Rx-360, a non-profit consortium involving pharmaceutical and raw material
supplier companies. This consortium has been established to share market
surveillance, develop operating standards, create an independent supplier audit
function to improve the efficiency, oversight and accountability of the
pharmaceutical supply chain, and advance technologies for detection and
prevention of material adulteration. Other panel speakers include: Vinny
Browning – Sr. Manager QC, Amgen; Kimberly L. Colson, Ph.D. – Business
Development Manager, R&D Division,, Bruker BioSpin; and Jared Byrne, Amgen
