Skip To The Main Content

PDA 100 Aseptic Processing

Mar 28 - Apr 29, 2022
Bethesda, MD

  • Education
  • The Americas
Sold Out

Week 1 Dates: 28MAR2022 - 01APR2022
Week 2 Dates: 25APR2022 - 29APR2022

This training course has sold out. If you would like to be added to the waitlist, please contact [email protected] and state which session(s) you are interested in attending.

Overview

Please note that this training course will take place in person and has hands-on lab activities. Long pants and closed-toe shoes are required.

This 2-week, in-depth training course will provide a comprehensive background of knowledge for professionals involved in sterile product manufacturing. This training course will help participants improve their aseptic processes and address contamination control issues that they may encounter.

During this training course, participants will learn about environmental monitoring systems, facility cleaning and disinfectant qualification, aseptic cleanroom operations, filtration, sterilization, aseptic process simulation (media fill), and regulatory requirements. Hands-on activities will include gowning qualification, facility cleaning and disinfection, aseptic technique qualification, aseptic process simulation, and microbial identification.

For more options and/or related training courses, please visit the page(s) below.

PDA Aseptic Processing Training Courses

Ask a Question

Agenda

  • This training course generally runs from 08:00 to 18:30 each day. Breakfast will not be provided, but lunch will be provided.

Trainers

Hal Baseman
Hal Baseman
ValSource Inc.
Bio
Hal Baseman
ValSource Inc.

Hal Baseman is the Chief Operating Officer and a principal at ValSource Inc. Mr. Baseman has over 40 years of experience in the pharmaceutical, medical device, and biotechnology industry. He has been the Chair of the PDA Board of Directors, the Co-chair of the Science Advisory Board and Co-leader of the Process Validation Interest Group, Co-chair of the EMA Annex 1 comment repose team, Co-leader of the task force on revision of Technical Report No. 22 – Aseptic Process Simulations, Co-leader of the task force for Technical Report No. 44 – Risk Management of Aseptic Processes, Co-leader of the task force for Technical Report No. 60 on Process Validation , Co-chair of the Committee for response to the FDA and the EMA Process Validation Guidance, and the Co-chair of the expert task force for the revision to Aseptic Processing Points to Consider Parts 1 an 2. He is the Co-lead for the Kilmer regulatory collaboration team and contributor on matters related to aseptic processing.

Mr. Baseman holds an MBA from LaSalle University and B.S. Biology from Ursinus College.
David K. Matsuhiro
David K. Matsuhiro
Cleanroom Compliance Inc.
Bio
David K. Matsuhiro
Cleanroom Compliance Inc.

David Matsuhiro is the founder for Cleanroom Compliance, Inc. He is an Expert Witness for the FDA in aseptic processing. Furthermore, he has provided aseptic process training for numerous international regulatory agencies. David is currently the lead instructor for PDA’s Aseptic Processing class and Airflow Visualization Techniques and Practices. In the past, he worked as a consultant for Aseptic Concepts and KMI Systems, specializing in water/environmental systems and aseptic processing. He started his career working for Genentech, Inc., in various Manufacturing and Quality positions. David is a member of several professional associations, including PDA, the American Society of Microbiology, and the International Society of Pharmaceutical Engineers.

Additional Information

  • Learning Objectives

    Learning Objectives

    1. Assess airflow visualization to limit risk for product contamination
    2. Evaluate an environmental monitoring program by collecting sampling data and interpreting trends
    3. Describe the importance of filter integrity testing for aseptic operations
    4. Develop a robust media fill protocol, including appropriate interventions, observations and documentation requirements
    5. Correlate basic microbiology concepts and techniques to multiple aspects of aseptic processing
    6. Integrate sanitization techniques and disinfectant evaluation into a comprehensive contamination control program
    7. Interpret regulatory requirements for manufacturing sterile products produced by aseptic processing
  • Who Should Attend

    This training course is intended for professionals who are involved in sterile drug manufacturing.

    Departments
    Manufacturing, Quality Assurance Operations, Quality Control, Engineering

    Roles
    Manager, Operator/Technician, Analyst, Specialist, Engineer

Got a Question? We have answers

Contact Us

Travel

PLEASE READ  PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.

PDA Training and Research Institute

4350 East West Highway, Suite 110
Bethesda, MD

How to Get Here

By Air

The following airports are near the training course location: Ronald Reagan National Airport (DCA), Washington Dulles International Airport (IAD), and Baltimore Washington International Thurgood Marshall Airport (BWI).

By Car

There is a parking garage located at the training course location. The fee is $12/day. Please take your car with you once the training course has ended. After 18:00 hours, you will not be able to access the building or parking garage from the outside.

Other Options

Metro: Ride the Red Line of the Metro and depart at Bethesda station. It is a 5-minute walk from Bethesda station to the training course location. Amtrak: Ride Amtrak and depart at Union Station. From Union Station, ride the Red Line of the Metro and depart at Bethesda station. It is a 5-minute walk from Bethesda station to the training course location.

Directions

Registration Fees

Regular Price
Registration Type Price
All Participants $10,000

* For this member type or discount, online registration is not available, please contact [email protected].

Group Registration Discount: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.

GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA immediately and will receive a credit (registration fee paid). PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. Video, photo, and audio recordings are prohibited at all PDA events.

CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to [email protected].

Sponsors

Become a Sponsor

Interested in becoming a sponsor? Learn about opportunities and benefits.

Request Information

Exhibitors

Attendee List Email Scam

Unfortunately, emails are circulating that offer to sell attendee lists for many of PDA’s conferences and events. These emails are sent by scammers.

Note: PDA does not sell its exhibitor or attendee lists, and no third-party is authorized to distribute or sell any lists related to our events. Statements claiming to offer our attendee lists are fraudulent. If you receive emails that propose to sell PDA conference attendee lists, do not engage with the sender and delete the message immediately.

Become an Exhibitor

Interested in becoming an exhibitor? Learn about opportunities and benefits.

Request Information

Media Partners

Contact

Program Inquiries
Exhibition Inquiries
Training Course Inquiries

Tel: +1 (301) 656-5900
[email protected]

Tel: +49 (0) 30 43 655 08-10
[email protected]

Registration Customer Care

Tel: +1 (301) 656-5900 ext. 115
[email protected]

PDA Members Save Substantially