OCTOBER 22, 2014 (Wednesday)
Calibration in the Pharmaceutical Environment
The importance of calibration can not be overstated. Calibration is one of the Quality Systems that is of high importance to the overall Quality Management System that pharmaceutical manufacturers must employ in order to be compliant with regulatory authorities.
The presenters will address calibration system cGMP requirements, practical and effective facilities implementation, and include examples of tools for compliant and lean systems.
The focus of the discussions will be loop calibrations based on the process evaluations, and calibration systems as a part of the maintenance reliability program.
Examples of computerized and paperless calibration will be presented as possible tools within calibration programs.
Understanding of the processes and quality requirements shall be shown to be the centerpiece of any calibration system.
Who Should Attend?
Engineering, Validation and Quality personnel responsible for calibration and maintenance programs, instrument specialists responsible for specification of instruments, and calibration technicians responsible for actual instrument calibration. Professional Engineers from Pennsylvania and new Jersey can also collect 3 PDHs toward their licensing renewal.
Yefin Gudesblat, PE Consultant
Yefin S. Gudesblat, PE is presently working as a consultant engineer in the industry. He supports clients in various electrical, instrumentation and automation project engineering development roles. In 1971, Gudesblat completed his studies in physics and electrical technology in Odessa, Ukraine (formerly the USSR). He is a registered Professional Engineer in Pennsylvania, New Jersey and North Carolina. Gudesblat has over 30 years of experience in the pharmaceutical industry and has published several articles in the leading US technical journals, including Pharmaceutical Engineering.
Thomas Povanda, PMP, CMRP, Director of Global Reliability, Engineering and Maintenance, Merck Manufacturing Division (MMD)
Tom Povanda’s role at Merck is that of subject matter expert, providing leadership in the areas of asset management, reliability, automation and calibration for 14 manufacturing sites worldwide. This includes the development of long term maintenance strategies to improve maintenance operations, monitoring and maintenance of equipment and facilities by leveraging enterprise CMMS and CCMS applications. He leads the Asset Care Program for the Sterile Operations network associated with operational availability and site business continuity planning at Merck. Responsibilities include leading site engineering assessments, performing asset “lifespan” assessments, development and implementation of engineering business process changes and enhancements, and education and training functions.
Tom has 23 years of engineering and maintenance experience, which includes developing, implementing and overseeing business processes and systems supporting engineering and maintenance, with the objectives of increasing manufacturing efficiencies through best-in-class life cycle asset management. Tom has led various multifaceted capital projects involving MES, process, packaging, facilities and utilities.
Bernard Williams, M.E., Director, Sales Engineering & Consulting at Prime Technologies, Inc.
Bernard Williams is an executive with over 35 years of engineering and management experience with leading edge technology companies. He has worked in diverse fields such as Power Generation, Holography, Analytical Chemical Systems and Process Automation. For the last 15 years, Bernard has worked with Prime Technologies, Inc. as a Senior Technology Consultant and contributor to the development of ProCalV5, their compliant, computerized calibration management solution.
GSK Upper Merion Campus
709 Swedeland Road
King of Prussia, PA 19406
(Enter via first site entrance to the right off Swedeland Rd.)
Price & Registration
Young Professionals: $35
Retired, Unemployed, Student, Faculty: $10
ISA Members are considered welcome guests and are charged the same fees as ISPE members at such training and education events, per a standing arrangement with the Delaware Valley Section of ISPE arranged by our immediate past ISA Section President, Bill Dugary.