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PDA 468 Validation of Moist Heat Sterilization Processes

Oct 25 - Oct 27, 2023
Bethesda, MD

  • Education
  • The Americas
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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.

Based on PDA Technical Report No. 1: Validation of Moist Heat Sterilization Processes: Cycle Design, Development, Validation and Ongoing Control, this training course will provide a foundational understanding of sterilization science that can be applied in the selection of a cycle design approach, sterilization process development, process performance qualification and ongoing process control. Hands-on activities will include actual sterilization cycle operations and execution with data review. The class will then participate in brainstorming over possible solutions to challenges. If the attendee can bring an example of the load item, it will be integrated into the autoclave execution.

Participants will also receive a free copy of PDA Technical Report No. 1: Validation of Moist Heat Sterilization Processes: Cycle Design, Development, Qualification and Ongoing Control.

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

PDA Sterilization Training Courses

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Agenda

  • Training courses run from 8:30 to 16:00 each day unless noted on the agenda. Breakfast will not be provided, but lunch will be provided.

Trainers

Deborah J. Drew
Deborah J. Drew
Drew Quality Group, Inc.
Bio
Deborah J. Drew
Drew Quality Group, Inc.

Deborah (Debbie) Drew is the President and CEO of the Drew Quality Group, Inc. a tax exempt 501(c)(3) corporation dedicated to manufacturing high quality generic drugs with a diverse and inclusive workforce in the USA. The Drew Quality Group, Inc.’s mission is to address drug shortages in the United States while on-shoring high quality manufacturing jobs through the establishment of domestic manufacturing capacity, and enrichment of their local communities and science and engineering education.

Debbie is a veteran of the US Army and has, over a 26-year period, worked as a machinist while completing her Bachelor Degree then after graduating was a Manufacturing Management Access candidate at SmithKline & Beecham, then worked as an engineer in increasing level positions at AstraZeneca, then as a consultant for Parexel Consulting, then a Director at Avecia Biotechnology, then a Manager at Shire, then a Senior Engineering Manager at Abbott Laboratories, and then a Senior Engineering Manager at AbbVie before launching the Drew Quality Group, Inc. in 2014.

Deborah has an Associate Degree in Liberal Arts from City Colleges of Chicago (US ARMY extension program), a Bachelor of Science in Mechanical Engineering from Widener University, and a Master in Business Administration from the University of Phoenix.

Deborah teaches and lecturers on engineering topics for industry organizations, local colleges, universities, and participates in the Science, Technology, Engineering, and Mathematics (STEM) Education Coalition outreach activities to middle school and high school students.

Also, Debbie is the proud parent of two adult children, a daughter and a son.

Additional Information

  • Learning Objectives

    Learning Objectives

    1. Discuss microbiology and sterilization science and apply these concepts in the development of a scientifically sound and regulatory compliant sterilization program
    2. Develop a decision tree to select the most appropriate sterilization process based on the attributes of the load type
    3. Utilize the semi-log survivor curve equation in support of the development and ongoing control of the sterilization program
    4. Assess risk associated with the cycle phases and identification of key and critical process parameters in the development of the sterilization process for liquid and porous/hard goods load types
    5. List the critical elements of process performance qualification
  • Who Should Attend

    This training course is intended for professionals who design, validate and execute moist heat sterilization operations.

    Departments
    Manufacturing, Quality Assurance Operations, Validation, Engineering, Quality Control

    Roles
    Specialist, Analyst, Technician, Supervisor, Manager

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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 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

Early Registration
Registration Type Price By September 10, 2023
Member $3,149
Non-member $3,779
Gov't/Health Auth./Academic $2,449
Regular Registration
Registration Type Price After September 10, 2023
Member $3,499
Non-member $4,199
Gov't/Health Auth./Academic $2,449

* 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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