New guidelines and modern chromatographic solutions converge to ensure data quality in the pharmaceutical laboratory: Join Waters for a panel discussion and insights from the USP and MHRA

Advancements in laboratory instruments and consumables continue to enable the improvement of analytical measurements. However, the post-approval regulatory burden to revalidate analytical procedures and amend global licenses can be significant, creating barriers to improved analytical procedures and enhanced data quality. New regulatory guidelines are emerging as proactive approaches to control risk, improve quality and alleviate these challenges.

In this webinar, Waters experts will show the benefits of improved technology with robust, fit-for-purpose methods using the new Arc HPLC System. Examples will highlight enhancements that minimize day-to-day, instrument-to-instrument, and analyst-to-analyst variability, leading to greater confidence in data quality and ‘right first time’ data processing.

Highlighting new regulatory guidelines, Dr. Horacio Pappa, Director General Chapters of the United States Pharmacopeia, will present updates on: USP Chapter<1220> The Analytical Procedure Lifecycle; ICH Q2 guideline for validation; and the proposed ICH Q14 guidance on analytical procedure development.

The session will culminate in an expert panel discussion with Dr. Phil Borman, Senior Fellow and Product Quality Director at GSK, James Pound, Secretary & Scientific Director, British Pharmacopoeia Commission, Medicines and Healthcare products Regulatory Agency (MHRA), Dr. Pappa, and Heather Longden, Regulatory Expert at Waters, to discuss strategies for managing analytical procedure and technology improvements in the pharmaceutical laboratory within the context of new regulatory guidelines.

Presenter: Dr. Horacio Pappa (Director of the General Chapters Department, United States Pharmacopeia (USP))

Dr. Pappa has been with USP since 2003. He is currently the Director of the General Chapters Department, Science division of the USP. He provides scientific leadership to a team of scientific liaisons responsible for the activities of six different expert committees that cover the majority of the USP General Chapters. Horacio earned his Ph.D. in Pharmaceutical Chemistry from the University of Buenos Aires. He has authored many publications and peer-reviewed articles and is a frequent speaker and instructor on topics related to Chromatography and Validation. Prior to joining USP, he worked in the pharmaceutical industry in QA/QC. Horacio held the position of Assistant Professor of Quality Control in the Faculty of Pharmacy at Buenos Aires University, and Executive Secretary of the Argentine Pharmacopeia in the period 1997-2001. He is a Quality Engineer certified by the American Society for Quality.

Presenter: Heather Longden (Senior Marketing Manager, Pharmaceutical Intelligence, Waters Corporation)

After a number of years in training, supporting and selling Waters Software, Heather's current role is as a specialist in compliance to e-record regulations, acting as a resource to the global informatics community at Waters and the users of all Waters informatics products. This involves helping design the compliance into Waters informatics products and services, attending and presenting at specialist conferences, keeping up to date on the latest interpretations and amendments to the regulations and disseminating this information to the Waters field and corporate organizations.

Presenter: Dr. Phil Borman (Senior Fellow and Product Quality Director, GSK)

Phil Borman is a Chartered Chemist with 24 years of experience in the pharmaceutical industry, having obtained a Masters in chemistry from Manchester University, a Masters in applied statistics from De Montfort (Leicester) University and a Doctor in Sciences for his work in pioneering and developing Quality by Design (QbD) approaches for analytical procedures (also from De Montfort University). Phil is a Director and Senior Fellow at GlaxoSmithKline where he is accountable for Small Molecules Product Quality. Phil pioneered the adaptation of QbD principles to analytical methods and has published widely in the field of analytical chemistry. He currently co-leads the EFPIA ICHQ2(R2)/Q14 support team and is a member of the newly formed USP Measurement and Data Quality Expert Committee.

Presenter: James Pound (Secretary & Scientific Director British Pharmacopoeia Commission, Group Manager British Pharmacopoeia & Laboratory Services, Medicines and Healthcare products Regulatory Agency (MHRA))

James Pound joined the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) in 2008. He has worked in a variety of roles within the British Pharmacopoeia (BP) & Laboratory Services Group and in 2017 was promoted to the role of Group Manager and Secretary & Scientific Director of the BP Commission. He is a senior leader within the Agency and has responsibility for both the pharmacopeia and the Agency’s regulatory laboratory testing activities. He holds an honours degree in Chemistry and has previously worked in a variety of roles focused on analytical chemistry for both multinational pharmaceutical manufacturers and independent UK analytical laboratories.

Presenter: Moderator: Sarah Thomas (Editorial Team, SelectScience)

Sarah studied biology at the University of Bath, UK, and has worked in the Pharmaceutical Sciences Department of St. Jude Children’s Research Hospital, Memphis. As a member of the Editorial team, Sarah plays an integral role in shaping the content on SelectScience.