Course Description

This ten-day, two-week comprehensive training program, taught by numerous industry leading experts in their fields, with over 200 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!

Key Topics

Week 1

• Definition and scope of aseptic processing
• Facility design, HEPA certification, velocity and airflow studies
• Aseptic process simulations (media fills)
• Gowning and personnel qualification and good aseptic technique
• Basic microbiology, environmental monitoring and control systems
• Sanitization techniques and sterilization qualification
• Filtration and liquid filter integrity testing

Week 2

• Reading and evaluating media fills
• Good documentation practices
• Rapid microbial identifications
• Sterility testing and final product testing
• Product formulation and lyophilization
• Use and control of clean in place (CIP) systems
• Environmental data trending and excursion analysis

Who Should Attend

Department
Manufacturing | QA/QC | Engineering

Job Function
Directors, Managers | Leaders | Supervisors | Technicians/Specialists

Benefits of Attending

• Learn to relate and incorporate each component of aseptic processing into one operation for overall improved process and finished product
• Understand theory and practice behind personnel gowning and aseptic technique qualification to minimize risk of product contamination by personnel
• Use proper environmental monitoring techniques combined with a good cleaning and disinfection program to avoid common sources of contamination in your facility
• Learn to incorporate proper documentation practices into aseptic processing program to facilitate regulatory compliance

Learning Objectives

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 date, identify and interpret trends
• Incorporate proper gowning principles into a complete personnel certification 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

Faculty

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.

Class Schedule

The Aseptic Processing Training Program begins at 8:00 a.m. and ends at 6:00 p.m., Monday through Thursday. The course attendees will be released at 12:00 p.m. on Friday during Week 1, and at 2:00 p.m. on Friday during Week 2

Please arrive at the PDA Training and Research Institute 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 7:30 a.m. Lunch will be provided from approximately 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.

Continuing Education Credits

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.

Registration Fees

Standard		Government/ Health Authority **
Member	Non-Member	Member	Non-Member
$8,595	$8,895	$4,800	$4,800
All rates in U.S. dollars.

Location/Lodging Information

The course will be held at the PDA Training and Research Institute:

PDA Training and Research Institute
Bethesda Towers
4350 East West Highway, Suite 150
Bethesda, MD 20814
USA

Contact

James Wamsley
PDA Training and Research Institute
Senior Manager, Laboratory Education
Tel: +1 (301) 656-5900 x137
Email: wamsley@pda.org