Seminar Summary

This seminar will explore how regulatory inspections can be a collaborative effort to optimize compliance and overall quality. 

• What are today's inspection trends and expections?
• How can we improve our current systems and processes by understanding the trends and expectations in today's enforcement environment?
• What type of changes are we implementing due to current inspection trends?
• What's the cost of inspection readiness? 
• What types of collaborations and partnerships can impact inspection outcomes?

Who Should Attend

Departments
Research & Development | Regulatory Affairs | Manufacturing | Quality Assurance/Control | Marketing | Sales

Job Functions
Supply Chain | Clinical Supply Material Preparation | Executive Management

Presenters Bio

Zena Kaufman, Divisional Vice President, Global Pharmaceutical Operations, Abbott Laboratories

Zena is Divisional Vice President, Global Pharmaceutical Operations, Quality Assurance Small Business, including sites in Illinois, Puerto Rico and Ireland. Previous to joining Abbott in February 2006 in a corporate quality and regulatory role for external regulatory and compliance programs, Zena was Director of Quality at Searle and remained in the Quality organization through the mergers/acquisitions from Searle, Pharmacia and Pfizer. Within Pfizer, her role as Sr. Director of Regulatory & Compliance Initiatives included site compliance assessments and external advocacy.  Representing PhRMA, she had the privilege of serving as part of the Expert Working Group for ICH Q10, “Pharmaceutical Quality Systems”.  She is on the Board of Directors for the Parenteral Drug Association.  She has a bachelor’s degree from Queens College in Queens, NY and a master’s degree from the State University of NY at Stony Brook. 

She and her husband Lon have a grown son and a daughter and two adorable poodles: a large standard and a tiny toy.  

Monica Caphart, Supervisory Consumer Safety Officer, ORA, FDA

Monica Caphart is the Director, Domestic Operations Branch, Division of Domestic Field Investigations, Office of Regional Operations, ORA.  She began her FDA career in 1989 as an analyst in the Northeast Regional Laboratory, moved to ORA’s Division of Field Science as a Scientific Coordinator, then to CDER’s Office of Compliance where she served as a Senior Compliance Officer in the Division of Manufacturing and Product Quality (DMPQ) before assuming her current position in 2009.  In 1997 Monica was selected as DMPQ’s technical/regulatory specialist on pharmaceutical laboratory CGMPs.  In 2000 Monica was awarded a Mansfield Fellowship (a program whose focus is to enhance US/Japan government relations) which enabled her to study Japanese for a year, followed by a year working at Japan’s Ministry of Health, Labor and Welfare, where she learned about Japanese GMPs.  In 2008, Monica was seconded to the European Medicines Agency as a Visiting Expert.  She is also a training resource for FDA.  Monica holds a Bachelor of Science degree in Chemistry, a Master of Science degree in Pharmacology and a Masters in Public Health.

Registration contact

Jason E. Brown
Senior Programs Manager
Tel: +1 (301) 656-5900 ext. 131
Fax: +1 (301) 986-1093
Email: brown@pda.org