Speakers form the Validation & Verification Expert Panel at United States Pharmacopeia (USP):
Dr Christopher Burgess
Burgess Analytical Consultancy Limited, Member of the Validation & Verification Expert Panel at USP and Member of the ECA QC Group
Dr Burgess is a Chartered Chemist and has more than 40 years experience in the pharmaceutical industry primarily with Glaxo in Quality Assurance and Analytical R&D. He is a “Qualified Person” and was a member of the European QP Association advisory board for 10 years. He was appointed to the United States Pharmacopoeia’s Council of Experts 2010 to 2015 and again for 2015 to 2020 as well as being on the Expert Panel for Validation and Verification of Analytical Procedures. He is a visiting professor of the University of Strathclyde’s School of Pharmacy and Biomedical Sciences (SIPBS). In addition, he is the chairman of the ECA Analytical Quality Control Group Board and a member of ECA´s Extended Board and member of ECA´s Task Force on Data Integrity.
Consultant, Member of the Validation & Verification Expert Panel at USP
Jane Weitzel has been working in analytical chemistry for over 40 years for mining and pharmaceutical companies. She is currently a consultant specialising in laboratory management systems and ISO/IEC 17025, an auditor, and an educator. Jane has applied Quality Systems and statistical techniques, including the estimation and use of measurement uncertainty, in a wide variety of technical and scientific businesses. She has obtained the American Society for Quality Certification for both Quality Engineer and Quality Manager.
For the 2010 – 2015 cycle, Jane was a member of the USP Reference Standards committee and she is also a member of the USP Statistics Expert Committee for 2015 to 2020. In 2014 she was pointed to the Chinese National Drug Reference Standards Committee and attended their inaugural meeting in Beijing.
Pfizer, Member of the Validation & Verification Expert Panel at USP
Kimber Barnett, Ph.D. is a Research Fellow working in Analytical Research and Development at Pfizer Inc. in Groton, CT. In her current role, Kimber serves as a technical team leader responsible for late stage analytical development of drug substances and drug products as well as the late stage LC Method Development Group. Kimber obtained her Ph.D. in Analytical Chemistry from the University of Missouri focusing on chiral separations under the guidance of Professor Daniel Armstrong.
Dr Joachim Ermer
Sanofi, Member of the Validation & Verification Expert Panel at USP
Dr Ermer is Head of Quality Control Services Chemistry, Sanofi-Aventis Deutschland GmbH, Frankfurt, Germany and Global Reference Standards Coordinator of Sanofi Industrial Affairs. He studied biochemistry at University of Halle and has over 25 years experience in pharmaceutical analytics including development products, global responsibilities as Director of Analytical Processes and Technology, and Head of Quality Control. He is member of the EFPIA QbD working group and of the USP Expert Panel Validation & Verification.
Member of the Validation & Verification Expert Panel at USP
Phil Nethercote has recently retired from GSK where he was Head of Analytical for the GSK manufacturing division. He is a member of the USP Expert Panel on Method Validation and Verification and the BP Analytical QbD working party as well as co-editor of the book Method Validation in Pharmaceutical Analysis. Phil has a degree in Chemistry and a PhD in HPLC.
Speakers from the ECA Analytical QC Group:
Actavis, a TEVA Company
Member of the ECA QC Group
Silviya Dimitrova is Associate Director EU Third Party Testing and Release at Actavis, a TEVA company, Bulgaria and has 28 years experience in pharmaceutical industry.
She started her career in R&D as an analytical chemist and more recently as Head of Analytical activities department with a focus on method development and validation.
Since 2008 she has been working in Quality and currently is Associate Director in charge of the department with responsibilities for Quality Control of imported products supplied by manufacturers from non EU countries. She has an experience in analytical transfers between sites within the company and with contract manufacturers, and also in Quality Control/testing and QP release of the imported to EU products.
Dr Gerd Jilge
Boehringer Ingelheim Pharma GmbH & Co. KG
Member of the ECA QC Group
After finishing the PhD in fast HPLC separations on proteins Gerd became a product specialist employed at Shimadzu followed by a post-doctoral fellowship in Paris on chromatography on biopolymers in 1990. In 1991 Dr Gerd Jilge came to Boehringer Ingelheim working in product development where he was responsible for method development and validation for the application of analytical procedures. In 2000 Gerd took a position in Drug Regulatory Affairs of Boehringer Ingelheim GmbH with the focus on CMC documentation for the submission of new and registered drug products. Since July 2007 he is working in Quality Control on topics like method transfer as well as method optimization and validation for active drug substances.
In 2014 Gerd became a member of an EDQM expert group.
Dako Denmark A/S, an Agilent Technologies Company
Member of the ECA QC Group
Margarita Sabater is currently Process and Method Validation specialist and educator at Dako (Agilent Technologies). She has more than 20 years experience within analytical Research and Development as well as QC from pharmaceutical companies. Her main area of expertise is within development and validation of bioanalytical and biological assays. Margarita has applied risk-based approaches in the development and validation of analytical procedures and established control and monitoring strategies through the analytical procedure life cycle. She also has experience in analytical transfers between sites within the company and with contract manufacturers.