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Modern Thermal Validation Using Real Time Wireless Dataloggers

May 14, 2020
Bethesda, MD

  • Education
  • The Americas
Closed

Overview

Thermal validation is essential to ensure product quality in manufacturing and distribution operations. Advancements in mapping technology provide for real-time gathering and analysis of validation data for temperature-controlled processes. This simplifies the thermal validation process and makes it more efficient while reducing risk and maintaining data integrity.

This interactive training course will cover current regulations and guidelines for thermal validation, applicable testing methodology and real-time mapping technology. Participants will learn how to properly design and perform thermal validation studies for typical industrial processes. Participants will also learn about current mapping technology and its application. The training course includes lectures, case studies and exercises developed by experts in thermal validation.

Please note that this training course has hands-on lab activities.

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Agenda

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

Trainers

Cesar Mirabal
Cesar Mirabal
Lives International
Bio
Cesar Mirabal
Lives International

Cesar Mirabal advises life sciences organizations on how to achieve value through regulatory compliance. He has an engineering background coupled with a Master's Degree in Management and certifications as Six Sigma Black Belt and Certified Manager of Quality/Operational Excellence, and over 25 years of experience in project management, validation, and regulatory compliance, quality assurance, calibration & maintenance and continuous improvement. He has extensive experience with facilities, utilities, manufacturing equipment and support systems, including thermal validation, computer system validation, technology transfer, commissioning, start-up, qualification and validation. His previous experience at Bayer AG, Alcon Laboratories, Johnson and Johnson, Mentor Technical Group, PSC Biotech and Pharma-Bio Serv includes roles as Engineer, Supervisor, Manager, Director, Managing Director and General Manager.
Quy Tran
Quy Tran
Lives International
Bio
Quy Tran
Lives International

Quy has a B.S. in Biophysics from UCLA and is on the board committee for the ISPE Los Angeles Chapter. He has 10+ years of experience in the biotechnology and pharmaceutical industry, holding positions in Quality, analytical chemistry, and drug product process development. As a Lab Manager at Amgen, he oversaw the procurement, qualification, and maintenance of equipment and analytical tools. Now with Lives International, Quy is focused on ushering a new era for thermal validation incorporating new technologies to address the globalization and harmonization of pharmaceutical manufacturing standards.

Additional Information

  • Learning Objectives

    Learning Objectives

    1. Identify current regulations, applicable guidelines and their acceptance criteria for specific processes
    2. Choose a proper testing methodology for a thermal validation type
    3. Recognize mapping technologies and their application
    4. Calculate test results from mapping data
    5. Compare test results against acceptance criteria
  • Who Should Attend

    This training course is intended for professionals who develop, execute or review thermal validation studies.

    Departments
    Validation, Engineering, Process Development

    Roles
    Specialist, Scientist, Engineer, Supervisor, Manager

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Travel

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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.

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Registration Fees

Early Registration
Registration Type Price By March 27, 2020
Member $1,799
Non-member $2,159
Gov't/Health Auth./Academic* $1,399






Regular Registration
Registration Type Price After March 27, 2020
Member $1,999
Non-member $2,399
Gov't/Health Auth./Academic* $1,399






* 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.

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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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