Presentations

PDA-SE Dinner & Dialogue Events 2013

Cold Chain Monitoring Devices: The Good, the Bad & the Ugly
Tim Anderson, ELPRO Services, Inc.

Disinfectant Efficacy Testing for Critical Environments
Marc Rogers, PhD, Steris Life Sciences

PDA-SE Fall Conference, Oct. 2013

Bias in Drug Develpment and Use: How Do We Get Things Right?
Ross McKinney, Jr, MD, Duke University School of Medicine

Modern Rules for an Old Practice: Sensor Placement for GMP Temperature Mapping
Paul Daniel, Vaisala Inc.

CMOs and Quality Agreements: A Roadmap to Regulatory Guidance Sources
Sandra Boyd, MBA, CQA, RAC, Biogen Idec

Can Quality Solve the Equation?
Anders Vinther, Genentech & Roche

Trends and Regulations in Cleaning and Disinfection
Jim Polarine, Steris

The Top 5 Things Learned at PDA/FDA
Patti Rossman, Globiox

PDA-SE Lab Conference, Aug. 2013

Special Agent for Contamination Control: The QC Micro Lab
Teri C. ("T.C.") Soli, PhD, Soli Pharma Solutions, Inc.

Rapid Methods Technologies: Finding the Guilty Party Faster!
James Spedding MT (ASCP), EMD Millipore

Mission Impossible: Low Level Detection Challenges
Jerry Dalfors, JD Technologies

Holding Innocent Batches Hostage: The Case for Parametric Release
Michele Creech, Grifols, Inc.

PDA-SE Lab Conference, Aug. 2011

Regulations for Handling Samples and Laboratory Testing from R&D Through Phase III Clinical Trials
Ron Hinkel, BioReliance, and Patti Rossman, Globiox

GLP vs GMP vs GCP
Dominique Pifat, PhD, MBA, The Biologics Consulting Group

Bench Scale and Beyond: FT-NIR Spectrophotometry Validation Hurdles, Chemical Issues, and Benefits
Jerry Dalfors, JD Technologies

Validating Your Rapid Micro Method
David Jones, Rapid Micro Biosystems

Microbial Identification for the 21st Century: The MALDI Biotyper
Gary Kruppa, Bruker Daltonics

PDA-SE Spring Convergence, March 2008

Technology Transfer, A Quality Systems Approach
Frank Kohn, PhD, FSK Associates, Inc.

Deciding to Stand Firm With FDA and Suceeding
Daniel Jarcho, McKenna Long & Aldridge LLP

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