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PDA 575 Validation of Biotechnology-Related Cleaning Processes

May 11 - May 13, 2021
Bethesda, MD

  • Education
  • The Americas
Cancelled

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.

Based on PDA Technical Report No. 49: Points to Consider for Biotechnology Cleaning Validation, this complete, hands-on training course covers both automated clean-in-place (CIP) and manual cleaning for biotechnology manufacture.

During this training course, you will have the opportunity to work with a functional CIP skid to help you understand everything from the impact of system design on cleanability to how to take swab samples and set acceptance criteria. You'll gain direct experience setting up an effective cleaning program by going through a systematic approach to cleaning validation. Areas of focus include initial evaluation of the equipment to be cleaned, analytical techniques, worst-case conditions, multi-product cleaning, cleaning cycle development and validation of the cleaning process.

Participants will also receive a free copy of PDA Technical Report No. 49: Points to Consider for Biotechnology Cleaning Validation.

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

PDA Cleaning Training Courses

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Agenda

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  • Training courses generally run from 8:30 to 16:00 each day. Breakfast will not be provided, but lunch will be provided.

Trainers

Rebecca A. Brewer
Rebecca A. Brewer
Quality Executive Partners
Bio
Rebecca A. Brewer
Quality Executive Partners

Rebecca Brewer has more than 30 years of experience in validation and compliance within the pharmaceutical, biopharmaceutical and medical device industries. She began work with Quality Executive Partners, a boutique consultancy, to make a difference in pharmaceutical consulting in 2013.

Becky’s expertise is in product and process development and transfer, process validation, equipment qualification, computer system validation, cleanroom qualification, cleaning validation, and quality systems. She has worked in a wide range of industry segments including aseptic processing, oral solid dose, biotechnology, tissue for implantation, medical devices and API. Prior to working with Quality Executive Partners, Becky was Director of Consultancy and GMP Compliance with Dober, where she assisted customers with challenging validation and compliance problems, including Cleaning Validation. Prior to working with Dober, Becky was a senior consultant with Raytheon Engineers & Constructors’ Validation Services Department (now Washington Group). Prior to joining Raytheon, Becky worked for Bristol-Myers Squibb in New Brunswick, New Jersey. In addition to teaching PDA’s Biotechnology Cleaning Validation course, Becky is the instructor for both ISPE’s Cleaning Validation and Clean-In-Place courses. She also frequently conducts site-specific validation and GMP compliance training for individual companies.

Additional Information

  • Learning Objectives

    Learning Objectives

    1. Discuss the principles of cleaning and cleaning validation
    2. Describe CIP system design and operation
    3. Analyze cleaning engineering, physics, and mechanics
    4. Develop cleaning validation protocols for CIP systems and cleaning processes
    5. Discuss numerous cleaning validation tips, techniques, and pitfalls
  • Who Should Attend

    This training course is intended for professionals who are involved with equipment cleaning processes that support sterile drug manufacturing.

    Departments
    Manufacturing, Quality Assurance Operations, Quality Control, Engineering

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

Early Registration
Registration Type Price By March 27, 2021
Member $3,149
Non-member $3,779
Gov't/Health Auth./Academic* $2,499

Regular Registration
Registration Type Price By March 27, 2021
Member $3,449
Non-member $4,199
Gov't/Health Auth./Academic* $2,499

* 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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