Led by Mike Vileikis, Sam Halaby, Andrew Christofides, P.E., and Russ Somma, PhD
Led by Tom Piombino, PE, Jeff Odum, CPIP, and Chuck Stock, MBA, CxA, Lean Certified
Led by: John Gilroy, P.E., Lean Certified, John Costalas, LEED AP, and Dan Leorda, P.E.
Led by Paul Valerio, Jason S. Collins, RA, NCARB, Robert Roy, P.E., and Jerrod Shook
Led by Kevin Swartz, Len Pauzer, Tina Gushue and William Ambrose
June 15-18, 2015
Pennsylvania Convention Center
September 28-30, 2015
Las Vegas, NV
October 19-23, 2015
The Inn at Longwood Medical
Risk - Based Verification of Facilities, Systems and Equipment (2011 ISPE Guide) Training & Workshops
Instructor: Mr. Daniel G. Franklin, CIRM, CxA
8.30 – 17.00
Using interactive workshops apply ASTM E 2500-07 principles and ICH Q8(R2), Q9, and Q10 to the documented verification of pharmaceutical and biopharmaceutical facilities. Templates will be developed to facilitate the translation of the scientific knowledge about the product and process into documented specification, design, and verification of facilities, systems, and equipment.
An Overview of Biopharmaceutical Manufacturing Processes (T24)
Instructor: Mr. Mark F. Witcher, PhD
8.30 – 17.00
Gain an in-depth understanding of how and why biotech processes work. Discuss the relationships between product, process, and facility attributes and current regulatory guidance impacting process development and execution. Compare various process aspects of upstream and downstream operations and recognize options available for single use technologies.
November 8-11, 2015
Philadelphia Marriott Downtown