The presentation will cover the complications associated with keeping aging biological manufacturing facilities cGMP compliant; the implementation of novel technologies such as single use bags/connectors, in process analyzers, and isolator technologies in both aging and new pharmaceutical manufacturing facilities; and impacts of such regulatory compliance hot topics, i.e., validation/qualifications and data integrity on biological licensed product applications and regulatory inspections.


Linda Kramer
Director, GSK Global Regulatory Affairs, CMC Excellence Facilities Team
Ms. Kramer has over 20 years of experience in the pharmaceutical industry including regulatory affairs and quality assurance. In her current role, Linda's team is responsible for worldwide variations between GSK's vaccine manufacturing facilities (locations in Belgium, Germany, Italy, US and Canada) and the Center for Biologics Evaluation and Research (CBER) and worldwide Health Authorities. Her career accomplishments include providing the module 3.2.A.1 for eight new BLAs and numerous post approval submissions maintaining critical supply for GSK's vaccines. Ms. Kramer has her Masters in Science in QA/RA from Temple University.

Terry Ward
RAC, Ward Regulatory Compliance Consulting
Ms. Ward has over 25 years supporting the pharmaceutical, biotech and vaccine industry in regulatory affairs, regulatory compliance and quality. She has direct experience with regulatory authorities such as FDA/EMA/MHRA to achieve and maintain licensure of pharmaceutical products to meet the needs of patients. Her career accomplishments include submission and licensure of GSK's Fluarix (Influenza Vaccine). The first vaccine to be licensed under accelerated approval regulations. Ms. Ward earned RAC Certification from Regulatory Affairs Professional Society in December 2002. Currently, Ms. Ward is an independent consultant.

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