Selection and Auditing of Analytical Contract Laboratories: Best Practices for Pharmaceutical Scientists

Why Should You Attend:

Major paradigm shifts in the pharmaceutical industry business model over the past decade have led to increased emphasis on drug discovery with a proportionate decreased emphasis on development activities for many large pharmaceutical companies. In addition, the number of smaller “start-up” companies, particularly in the biopharmaceutical area, has significantly increased. These smaller companies often have limited resources for development activities, and along with larger companies with reduced internal resources allocated for development, have turned to outsourcing as a way to maintain full development capacity. Of the various pharmaceutical development activities and work packages, those involving analytical testing are prime candidates for outsourcing.

Selection and qualification of contract laboratories (i.e., contract research organizations; CROs) often falls to pharmaceutical scientists within a given organization. Many pharmaceutical scientists are not trained in best industry practices for either task and rely on internal procurement and quality organizations for guidance.

This webinar is designed to assist pharmaceutical scientists who have been given responsibility for the outsourcing of analytical testing activities related to pharmaceutical development. Topics covered will include: criteria for CRO selection, basic principles of quality (i.e., GXP) auditing and qualification of a CRO, technical qualification of a CRO, business proposals and study protocol development, and management of on-going projects at CROs. This webinar is intended to build the confidence of pharmaceutical scientists in their ability to be successful in the growing field of outsourcing management.

Learning Objectives:

Upon completing this webinar, participants should:

• Understand the process of CRO selection for analytical testing
• Gain knowledge of the basic principles of quality auditing of a CRO; including audit planning, scheduling, conducting an audit, and the audit report process
• Understand the development of business proposals, quotations, quality agreements and study protocols
• Understand the process of technical qualification of a CRO
• Be comfortable with the process of management of CRO activities
• Be familiar with best practices for the reporting of CRO results and the incorporation of CRO reports into regulatory submissions

Areas Covered in the Webinar:

This webinar will begin with a brief discussion of outsourcing trends in the pharmaceutical industry with a focus on the outsourcing of analytical chemistry sample analysis and other analytical development work packages. Continuing discussions will focus on:

• The CRO selection process, based on the nature of individual work packages
• Quality auditing of a CRO, assuming that the audit is led by a pharmaceutical scientist
• Technical evaluation of a CRO
• Preparing and evaluating requests for proposals
• Developing study protocols
• Best practices for CRO management, micromanagement versus hands-off
• Working with a CRO to create reports for regulatory submission

The webinar section on CRO quality auditing will present case examples of audit proposals and schedules, audit checklists, and audit reports. Case examples will also be presented in support of the sections on CRO selection, development of study protocols, CRO management and mismanagement, and CRO reports for regulatory submission.

Who Will Benefit:

This webinar is designed for pharmaceutical scientists who have been given responsibility for the outsourcing of analytical testing activities related to pharmaceutical development. This includes individuals who have no experience with pharmaceutical outsourcing as well as those who may have some experience but wish to enhance their knowledge. The following personnel will benefit from the course:

• Pharmaceutical scientists
• Analytical chemistry professionals
• Pharmaceutical development managers
• Quality professionals
• Regulatory professionals
• Compliance professionals
• Quality auditors
• Pharmaceutical manufacturing professionals
• CRO management and staff

Daniel Norwood
Executive Partner, SCIO Analytical Consulting LLC

Dr. Daniel Norwood joined SCIO Analytical as Executive Partner in June 2015. Prior to SCIO Analytical, Dr. Norwood was a key technical employee at Boehringer Ingelheim Pharmaceuticals where he was successful in various pharmaceutical development roles, including Director Physical and Chemical Analysis. In June 2015, Dr. Norwood retired with the title of Distinguished Research Fellow in Analytical Development. Prior to joining Boehringer Ingelheim, Dr. Norwood, with Dr. Feinberg, founded the Structural Chemistry Group at Magellan Laboratories, later Catalent Pharma Solutions, which became widely recognized for its work in pharmaceutical impurity structure elucidation, and in leachables and extractables characterization. Prior to Magellan, he was a pharmaceutical development scientist at the Glaxo Research Institute.

Dr. Norwood is an internationally recognized expert in the field of leachables and extractables assessment in pharmaceutical development and manufacturing. He served as chair of the widely-quoted Product Quality Research Institute (PQRI) Working Group on leachables and extractables in inhalation drug products. He is also a member of the PQRI Working Group on leachables and extractables in parenteral and ophthalmic drug products (PODP), and has served on various technical teams of the International Pharmaceutical Aerosol Consortium on Regulations and Science (IPAC-RS). Since 2010, he has served as a member of the USP Expert Committee on Packaging, Storage and Distribution where he chairs the subcommittee on extractables and leachables. Dr. Norwood has received several industry awards, including the CEO’s Award from Glaxo (1994), the President’s Award from Boehringer Ingelheim (2007), the Excellence in Research Award from PQRI (2009), and the Award for an Innovative Response to Public Health Challenges from USP (2013). Dr. Norwood completed his bachelor’s degree in Biochemistry at Virginia Tech and his doctorate degree in Environmental Chemistry at the University of North Carolina at Chapel Hill, School of Public Health.

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