This two-week comprehensive training program, taught by numerous industry leading experts in their fields, with over 300 years of combined experience will give you and your personnel the training and information needed to properly evaluate and improve your aseptic processes to ensure sterile products. This course provides the perfect balance of hands-on laboratory and lecture training, equipping you with tools and actual experience you can bring home and apply immediately on the job.

Two five-day sessions allow for an in-depth look into an expanse of topic areas. These two sessions are scheduled four weeks apart, allowing for intense, comprehensive learning with minimal impact on your job/organization.

With almost 50 hours of hands-on laboratory training and group project work, in addition to extensive coverage of topics during the lecture sessions, this is the most complete aseptic processing training program offered.

Early registration is recommended as the Aseptic Processing Training Programs tend to sell-out quickly!

Upon completion of this program, you will be able to:

• Demonstrate an increased proficiency of techniques and skills relating to aseptic processing
• Evaluate and improve current aseptic processing procedures at your facility
• Limit risk for manual product contamination with airflow visualization studies
• Evaluate your environmental monitoring program to collect appropriate data, identify and interpret trends
• Incorporate proper gowning principles into a complete personnel qualification program
• Describe the importance of filter integrity testing when filtering water, gases or proteinaceous solutions
• Develop robust media fill protocols including appropriate interventions, observation and documentation procedures
• Discuss finished product testing requirements
• Correlate basic microbiology concepts and techniques to multiple aspects of aseptic processing
• Integrate industry-approved sanitization techniques and disinfectant evaluation into a comprehensive contamination control program
• Interpret regulatory requirements for manufacturing sterile products produced by aseptic processing

David Matsuhiro, Cleanroom Compliance, Inc.
David Matsuhiro is the principal for Cleanroom Compliance, Inc. He 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 and the International Society of Pharmaceutical Engineers. 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.

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 #100 | ACPE #0116-0000-10-100-L04-P | 8.0 CEUs
Type of Activity: Knowledge, Application