· 3 min read
ANN ARBOR, Mich., USA and York, UK – NSF, a global public health and safety organization, has appointed Lynne Byers as Executive Director and David Waddington as Director of NSF’s pharma biotech services in Europe.
In her role, Lynne Byers oversees consulting, auditing and training services for a variety of pharmaceutical operations in Europe. She also provides strategic consulting and training services and assists clients in establishing and implementing remediation plans to address audit findings and regulatory actions.
Byers brings more than 35 years of extensive pharmaceutical manufacturing management and quality assurance (QA) experience to NSF’s pharma biotech business, including manufacturing management and QA for a wide range of sterile and non-sterile dosage forms. Prior to joining NSF, she was the Global Head (VP) of External Supply Operations QA for Novartis in Switzerland. She also worked as Head of Inspectorate and Licensing for the MHRA, where she was responsible for the manufacturing authorizations of Qualified Persons (QPs). Byers’ international experience includes QA auditing of pharmaceutical manufacturers who are suppliers to the worldwide pharmaceutical industry, and the management of QA teams in country affiliates. She is fully conversant with current EU and FDA GMP regulations and requirements, and is eligible to act as a Qualified Person, having served in the role of QP assessor on behalf of the Royal Society of Chemistry from 1999 to 2004. Byers is a Fellow of the Royal Society of Chemistry and a Member of the Pharmaceutical Quality Group.
In his new position, David Waddington’s responsibilities include the establishment, promotion and growth of NSF’s consulting, auditing and training services in Europe. In addition, he is the key account manager in the development and maintenance of business relationships.
Waddington comes to NSF’s pharma biotech team with over 30 years of experience in a variety of roles for three major international pharmaceutical organizations. His most recent appointment prior to NSF was Quality Director, Global Regulatory Compliance for Catalent Pharma Solutions. Waddington also has extensive experience in QA auditing of pharmaceutical suppliers and manufacturers in Europe, North America and Asia-Pacific. He is fully conversant with current EU and FDA GMP regulations and requirements, and is eligible to act as a Qualified Person under the permanent provisions. Waddington is a Member of the Royal Society of Chemistry and a Member and Secretary of the Pharmaceutical Quality Group.
“Both Lynne and David bring a wealth of experience to NSF’s pharma biotech service and we are thrilled to have them on board. Our group is very team-focused and it is a pleasure to welcome Lynne and David to the team. In just a few weeks they have settled in brilliantly and are already working with key clients to protect patients and businesses worldwide,” said Mike Halliday, Executive Vice President of Pharma Biotech, NSF.
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NSF (nsf.org) is a global independent organization that writes standards, and tests and certifies products for the health sciences, water, food and consumer goods industries to minimize adverse health effects and protect the environment. Founded in 1944, NSF is committed to protecting human health and safety worldwide. With clients in more than 170 countries, NSF is a Pan American Health Organisation/World Health Organisation (WHO) Collaborating Center on Food Safety, Water Quality and Indoor Environment.
NSF’s health sciences services include training and education, consulting, auditing, GMP and GLP analytical testing, DNA testing, certification, R&D, regulatory guidance and corporate compliance for the pharma biotech, medical device, dietary supplement and bottled water/beverage industries throughout the product lifecycle. NSF wrote the only American National Standard (NSF/ANSI 173) that verifies the health and safety of dietary supplements and also tests and certifies products to this standard.
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