What makes this course different?
PDA has developed a new course in response to industry feedback and attendees of the Aseptic Processing Training Program.
This five-day comprehensive training program will give you and your personnel the tools necessary to optimize your Quality Systems associated with Aseptic Processing. Taught by leading industry experts with over 150 years of combined experience, this course includes almost 50% laboratory interaction to maximize performance. Major topics to be covered include; Risk Management, Sterility by Design, troubleshooting and solving sterile filtration issues, investigations and CAPA, and how to effectively implement change within a structured regulated environment.
Manufacturing - Directors, Managers, Leaders, Supervisors, Technicians, Specialists
QA/QC - Directors, Managers, Technicians, Microbiologists and Specialists
Engineering - Directors, Managers, Technicians, Engineers and Specialists
What challenges/problems does this course identify and offer solutions to?
What are the benefits of attending?
At the conclusion of this course, you will have:
What makes this course different?
David Matsuhiro, President, Cleanroom Compliance, Inc.
David Matsuhiro is the president of Cleanroom Compliance, Inc. Matsuhiro has worked as a consultant for Aseptic Solutions and KMI Systems, specializing in water, environmental systems and aseptic processing. He has also worked for Genentech Inc. in a variety of environmental control positions. Matsuhiro is a member of several professional associations, including PDA, The American Society of Microbiology (ASM) and The International Society of Pharmaceutical Engineers (ISPE). He received BS degrees in Microbiology and Chemical Engineering from San Jose State College.
Harold Baseman, Chief Operating Officer and Principal, ValSource LLC
Hal Baseman is Chief Operating Officer and a Principal at ValSource LLC, a 110 employee validation consulting and service firm. He has over 30 years of experience in pharmaceutical operations, validation and regulatory compliance. Hal has held positions in executive management and technical operations at several drug manufacturing and consulting firms. Hal is a member of the PDA Board of Directors, Co-Chair of the PDA Science Advisory Board, Co-Leader of the PDA Validation Interest Group, Co-Chair of the PDA Aseptic Process Simulation Technical Report #22 Task Force on Aseptic Process Simulation, and was Co-Chair of the PDA Risk Management Task Force responsible for writing Technical Report #44 on Quality Risk Management of Aseptic Processes. Most recently Hal co-chaired and led the PDA response to the FDA on draft Process Validation Guidance. Hal is a long time member of the PDA and its Training Research Institute faculty. He is a frequent presenter on subjects related to Quality Risk Management, Validation, and Aseptic Processing. Hal holds an MBA in Management from LaSalle University and a B.S. in Biology from Ursinus College.
Government / Health Authority / Academic
|Price on or before October 3, 2014||$5,050||$5,295||$3,300||$3,400|
|Price After October 3, 2014||$5,595||$5,895||$3,300||$3,400|
All rates in US dollars.
This course begins at 8:00 a.m. and ends at 5:00 p.m. unless otherwise noted on the confirmation letter or in course information posted on the website or in the course brochures.
Please arrive at your course location approximately thirty minutes before the start of the course to register and receive your course materials. Please be sure to bring your confirmation letter as proof of registration during check-in. TRI will not allow persons to attend a course without payment, or guarantee of payment.
A continental breakfast will be served before class beginning 8:00 a.m. Lunch will be provided from 12:00 – 1:00 p.m. Snacks will be provided during the morning break from 10:00 – 10:15 a.m. and the afternoon break from 2:30 – 2:45 p.m.
The course will be held at the PDA Training and Research Institute:PDA Training and Research Institute
For more information, please contact:
Senior Manager, Laboratory Education
Tel: +1 (301) 656-5900 ext. 137
The PDA Training and Research Institute is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Education Units (CEUs) following the successful completion of an accredited course and submission of the provided evaluation forms. Statements of Credit for CEUs earned will be mailed within four to six weeks of the event.
PDA #433| ACPE #0116-0000-11-433-L04-P 3.0 CEUs
Type of Activity: Application