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Tuesday, June 28 • 2:00pm - 3:15pm
#245: Risk-Based Inspections

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Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

Inspections are a critical component for assuring product quality. The adoption of a risk-based approach to inspections has enabled the integration of product review with traditional inspection criteria and focuses efforts on inspection issues rather than simply on assurance of compliance. This session will highlight ongoing efforts and initiatives geared towards the continuing implementation of risk-based inspections.

Learning Objectives

Discuss related procedural and/or policy challenges and present specific case studies related to risk-based inspections; Identify best practices and ideas for future discussion with regard to risk-based inspections; Identify potential areas for further collaboration on risk-based inspections.


Mahesh R. Ramanadham, PharmD, MBA


Quality Agreements: Defining the Business of Pharmaceutical Quality
Karen Bossert

Integrated Quality Assessment of the Manufacturing Process and Facilities
Robert Iser, MS

avatar for Mahesh Ramanadham

Mahesh Ramanadham

Division Director (Acting), Div. of Inspectional Assessment, OPF, OPQ, CDER, FDA
Acting Director for the Division of Inspection Assessment within OPQ/OPF. His division is primarily responsible for the center level discipline review of facilities and inspections in support of drug applications. He joined the Agency in November 2009 after graduating with his PharmD from the University of Maryland and his MBA from the University of Baltimore. Prior to FDA, he had experience in the generic pharmaceuticals industry. He continues... Read More →


Karen Bossert

Vice President, Scientific Affairs, Lyophilization Technology, Inc.
Karen Bossert is the Vice-President, Scientific Affairs at Lyophilization Technology, Inc. She has over 25 years of experience in pharmaceutical manufacturing and development. She received her Bachelor of Science degree in Pharmacy and her Doctorate in Pharmaceutics. | Karen has authored and presented numerous papers and courses in freeze drying. She currently teaches a course on Validation of Lyophilization at the PDA-TRI.
avatar for Robert Iser

Robert Iser

Acting Director, Office of Process and Facilities, OPQ, CDER, FDA
Bob joined the FDA in 2003. He is currently the acting Director of the Office of Process & Facilities. Prior to the formation of OPQ, Bob was acting Associate Director for Policy Development in OPS. He was also a Division Director and CMC Team Leader in OGD. Prior to joining the FDA, Bob spent 7 years in the pharmaceutical industry with experience related to management of quality systems, method development, and support of manufacturing process... Read More →

Tuesday June 28, 2016 2:00pm - 3:15pm
111AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA