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PDA 211.3 Quality and Compliance Management for Virtual Companies

Mar 24 - Mar 25, 2024
Long Beach, CA

  • Education
  • The Americas

Overview

Many biotech companies and some pharma companies today are small, “virtual” organizations that outsource most GxP-governed activities such as clinical trials, manufacturing, packaging, laboratory testing, and drug safety monitoring. Such companies often lack in-house knowledge of GCP, GLP and GMP requirements, or have such knowledge vested in very few people. The prospect of an FDA inspection can be a daunting one, as can ensuring that your vendors will pass FDA scrutiny.

This training course will help you understand what you need to have in place, what the high-risk areas are, and how best to manage those risks as you grow and bring activities in-house. This training course explains the GMP, GCP and GLP responsibilities of virtual companies or others who predominately outsource GxP-governed activities.

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

PDA Quality and Compliance Training Courses
PDA Annual Meeting Training Courses

Agenda

  • The first day of this training course will run from 8:30 to 16:30 UTC -8. The second day of this training course will run from 8:30 to 12:30 UTC -8. An agenda will be made available soon. Breakfast and lunch will be provided.

Trainers

David L. Chesney
David L. Chesney
DL Chesney Consulting, LLC

Additional Information

  • Learning Objectives

    Learning Objectives

    1. Explain GMP and GCP requirements for virtual companies
    2. Decide which elements of your quality system should be managed in-house and how
  • Who Should Attend

    This training course is intended for professionals who are responsible for the GxP activities in their virtual company.

    Departments
    Quality Systems, Quality Assurance Operations, Research and Development, Regulatory Affairs, Training

    Roles
    Supervisor, Manager, Director, Auditor/Inspector

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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.

Long Beach Convention Center

300 E Ocean Blvd
Long Beach, CA

  • Accommodations

    More information coming soon.

  • Amenities

    More information coming soon.

How to Get Here

By Air

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By Car

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Other Options

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Directions

Registration Fees

Early Registration
Registration Type Price By February 8, 2024
Member $1,349
Non-member $1,619
Gov't/Health Auth./Academic $1,049

Regular Registration
Registration Type Price After February 8, 2024
Member $1,499
Non-member $1,799
Gov't/Health Auth./Academic $1,049

* 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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