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PDA 452 Application of Quality by Design and ICH Q9 Rules to Aseptic Environmental Monitoring and their Impact to Sterility Assurance

Oct 08, 2021
Washington, DC

  • Education
  • The Americas
Cancelled

Overview

This training course will enable participants to better use and interpret the ICH Q9 and Quality by Design (QbD) Guidelines for application in aseptic processes. Participants will learn to design and analyze their aseptic processes while considering the risk points and their management. They will also understand the impact to sterility assurance and the possibilities offered by the QbD Guidelines to improve their aseptic processes

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PDA Quality and Compliance Training Courses

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Agenda

  • Training courses generally run from 8:30 to 16:00 each day. Breakfast and lunch will be provided.

Trainers

Mark Hallworth
Mark Hallworth
Particle Measuring Systems, Inc.
Bio
Mark Hallworth
Particle Measuring Systems, Inc.

Mark has managed the design, installation, and validation of over 200 environmental monitoring system projects worldwide. He has designed several products specific for pharmaceutical environmental monitoring, including particle counters for explosive and corrosive areas and 21 CFR part 11 compliant software for batch test and release. He currently lectures for the PDA, ISPE, and other international pharmaceutical societies on environmental monitoring and GMP compliance design and validation. Mark has written over 100 technical papers on environmental monitoring and contributed to several books specific to this field. He was awarded the IEST James Mildon award for “significant contributions to the advancement and increase of knowledge in the field of contamination control.”
Ugo Omeronye
Ugo Omeronye
Particle Measuring Systems, Inc.
Bio
Ugo Omeronye
Particle Measuring Systems, Inc.

Ugo has worked with pharmaceutical companies to support quality assurance and control. She is especially skilled in data-driven corrective and preventative actions for environmental monitoring and contamination-control strategies affecting medical devices and drug production. Ugo earned her Master’s in Biomedical Sciences; focusing on pharmacology, validation methodologies, and technologies to effectively streamline sterile manufacturing.

Additional Information

  • Learning Objectives

    Learning Objectives

    1. Apply Quality by Design (QbD) Guidelines to aseptic processes
    2. Interpret the application of ICH Q9
    3. Apply risk management for aseptic processes
    4. Design an aseptic process based on QbD
  • Who Should Attend

    This training course is intended for professionals who are involved designing and analyzing aseptic processes for drug manufacturing.

    Departments
    Quality Control, Quality Systems, Quality Compliance, Engineering, Manufacturing, Quality Assurance Operations, Technical Operations, Validation

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

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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.

Grand Hyatt Washington

1000 H Street NW
Washington, DC

  • Accommodations

    Joining us in person? Book within the PDA block and be automatically entered to win a daily treat delivered to your hotel room!

    A block of rooms have been reserved for meeting participants at the Grand Hyatt Washington. The rate is $309 for single or double occupancy. Guestroom rates are subject to State and Local taxes. Reservations must be secured by Monday, September 6, 2021. After this date, reservations can be made on a space-and-rate available basis only. Check-in time is 3:00 p.m.; check-out time is 12:00 p.m.

    To make reservations, individuals may click on the reservation link above or call the Grand Hyatt Washington at +1 (202) 582-1234. Be sure to tell the reservationist that you are with the PDA Meeting to receive the PDA group rate.

    Individual Cancellation

    Please be aware that obtaining and canceling hotel reservations is the responsibility of the meeting registrant. Individuals will be responsible for payment of their own cancellation fees. The cancellation policy is 3 days in advance of arrival unless otherwise specified on your reservation information.

  • Amenities

    Please visit the hotel’s website for more information.

How to Get Here

By Air

Reagan National Airport (DCA) is approximately 4.2 miles from the hotel and all major carriers service this airport. Two other airports in the vicinity are both serviced by all major carriers: Dulles International Airport (IAD), 27 miles away, and Baltimore-Washington International Airport (BWI), 32 miles away. Taxi fares from DCA are approximately $25 one way, not including tip, and will take about 15 minutes. One way taxi fares from IAD is approximately $70 and from BWI about $85.

By Car

The Grand Hyatt Washington is located at 1000 H Street NW, Washington, DC 20001. $42 (per day) Self-Parking; $62 (per day) Contactless (SMS) Valet Parking.

Other Options

The Hotel lobby is connected to the WMATA Metro Center train station. Metro fare from Reagan National Airport (DCA) is approximately $2.30 (one-way). To plan your trip please visit www.wmata.com.

Directions

Registration Fees

Early Registration
Registration Type Price By August 24, 2021
Member $899
Non-member $1,079
Gov't/Health Auth./Academic* $699

Regular Registration
Registration Type Price After August 24, 2021
Member $999
Non-member $1,199
Gov't/Health Auth./Academic* $699

* 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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