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Live eLearning ‐ PDA 211.2 Quality and Compliance Management for  Virtual Companies

Sep 29 - Sep 30, 2020
1:30 PM
-
4:30 PM
| Eastern Standard Time
Online
  • Virtual
  • Education
  • Online
Cancelled

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 Assurance Training Courses

Trainers

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

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
  • Manufacturing
  • Quality Assurance Operations

Roles
  • Specialist
  • Manager
  • Director

Registration Fees

Cancelled
Registration Type Price
Member $600
Non-member $600
Gov't/Health Auth./Academic $600

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