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PDA 100 Aseptic Processing

Aug 02 - Aug 27, 2021
Bethesda, MD

  • Education
  • The Americas
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Week 1 Dates: 02AUG2021 - 06AUG2021
Week 2 Dates: 23AUG2021 - 27AUG2021

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. Please read our COVID-19 Facility Access Rules before registering for this training course.

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

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Agenda

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  • 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 Chief Operating Officer and a Principal at ValSource Inc. He has over 42 years of experience in pharmaceutical operations, validation, and regulatory compliance. He has previously held positions as the Chair of the PDA (Parenteral Drug Association) Board of Directors, the Co-Chair of the PDA Science Advisory Board, the Co-Leader of the PDA Aseptic Processing Points to Consider Task Force and the Co-Leader of the PDA Process Validation Interest Group. He is currently the Co-Chair of the PDA Annex 1 Response Team, as well as a long-time member of the PDA Training Research Institute faculty. Hal holds an MBA in Management from LaSalle University and a B.S. in 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

    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

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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 Washington/Bethesda area is serviced by the following airports: 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 do not leave your car in the parking garage past 6:00 p.m. as both the building and parking garage access doors are locked.

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
Member $9,799
Non-member $10,199
Gov't/Health Auth./Academic* $6,859

* 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].

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Contact

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Training Course Inquiries

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

Tel: +49 (0) 30 43 655 08-10

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Tel: +1 (301) 656-5900 ext. 115
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