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PDA 306 Technical Report No. 65: Technology Transfer

Sep 21, 2023
Washington, DC

  • Education
  • The Americas
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Overview

This training course, based on Technical Report No. 65: Technology Transfer, will cover the business process and technical considerations for technology transfer of large and small molecules. Major topics to be explored will include project management considerations, process and analytical transfers, risk management, documentation and knowledge management, and personnel training and skills. Participants will be given tools and strategies typically used in technology transfer such as process description, facility fit assessment, risk register and project dashboards.

Participants will also receive a free copy of PDA Technical Report No. 65: Technology Transfer.

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

PDA Quality and Compliance Training Courses
PDA Regulatory Training Courses

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Agenda

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

Trainers

Beth J. Haas
Beth J. Haas
Haas Pharma Consulting
Bio
Beth J. Haas
Haas Pharma Consulting
With over 30 years in the industry, Beth has versatile experience across product lifecycle phases covering CMC requirements, cGMP manufacturing, and CDMO management focusing on new product introductions and technology transfers for both APIs and drug products. She enjoys partnering with CDMOs across all platforms, working closely with procurement and supply chain to ensure compliance, and establishing strong relationships between the key functional areas to achieve regulatory approval. Beth is highly skilled in global team leadership, process development and engineering, quality risk management, GMP quality systems, and CMC regulatory filings. Currently, Beth co-leads the Technology Transfer interest group for PDA, was a co-leader for the recently released PDA Technology Transfer technical report (TR-65), and was an author on the ISPE Technology Transfer guide, 3rd edition.

Additional Information

  • Learning Objectives

    Learning Objectives

    1. Explain how the project management structure enables success
    2. Utilize tools used in technology transfer
    3. Differentiate between technology transfer approaches, such as internal versus external, and clinical versus commercial
  • Who Should Attend

    This training course is intended for professionals who are engaged in the transfer of manufacturing processes and analytical methods to internal and external sites.

    Departments
    Quality Control, Engineering, Regulatory Affairs, Technical Operations, Validation

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

Renaissance Washington, DC Downtown

999 9th Street, NW
Washington, DC

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  • Accommodations
    The Renaissance Washington, DC is the headquarter hotel for the 2023 PDA/FDA Joint Regulatory Conference!

    Rate: $331 USD for single/double occupancy, plus state and local taxes
    Cut-Off Date: Friday, 18 August 2023 (after this date the discounted PDA rate is no longer guaranteed)
    Check-In: 15:00
    Check-Out: 12:00

    Reservations

    Phone: +1 (800) 228-9290, make sure to refer to group code PDAN for the discounted conference rate
    Online:     Click on the reservation link above

    Individual Cancellation

    All cancellations must be received by 23:59 local time 72-hours before arrival to avoid a penalty of one night room and tax. Obtaining and canceling hotel reservations is the responsibility of the meeting participant. Individuals will be responsible for payment of their own cancellation fees.

  • Amenities

    Embrace the excitement of one of the world's most remarkable urban hubs at Renaissance Washington, DC Downtown Hotel. From museums to entertainment, this is the perfect base for exploring downtown DC. Additional perks for your hotel stay include a fully equipped, 24-hour fitness center. And at days end, relax in spacious hotel rooms with plush bedding, downtown views, Aveda bath products and Wi-Fi. Steps from shopping, dining, nightlife and sports, this hotel places the best of DC at your doorstep. Expect the extraordinary at Renaissance Washington, DC Downtown Hotel.

How to Get Here

By Air

The airports closest to the Renaissance Washington, DC Downtown hotel are Reagan National Airport (DCA, 4.6m/7.4km), Dulles International Airport (IAD, 27.8m/46.2km), and Baltimore-Washington International Airport (BWI, 32.1m/51.7km).

By Car

The Renaissance Washington, DC Downtown hotel is located at 999 9th Street NW, Washington, DC 20001. Both onsite parking ($35+/day) and valet parking ($61+/day) are available.

Other Options

The metro stations closest to the Renaissance Washington, DC Downtown hotel are Mount Vernon Square (yellow/green line, 0.4m/0.6km), Gallery Place (red/yellow/green, 0.3m/0.5km), and Metro Center (red/blue/orange/silver, 0.4m/0.6km). Please visit www.wmata.com for fare and schedule information.

Directions

Registration Fees

Early Registration
Registration Type Price By August 7, 2023
Member $899
Non-member $1,079
Gov't/Health Auth./Academic $699

Regular Registration
Registration Type Price After August 7, 2023
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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