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Live eLearning ‐ PDA 459.2 Biopharmaceutical Manufacturing under Regulatory Compliance: Process Strategies, CGMP Considerations

Sep 17 - Sep 18, 2020
1:30 PM
-
4:30 PM
| Eastern Standard Time
Online
  • Virtual
  • Education
  • Online

Overview

Biotechnology is the use of biological processes and components to provide useful products, services and tools for a variety of applications. Biological and drug products under the regulatory review and approval by the United States Food and Drug Administration are required to be manufactured in compliance with current Good Manufacturing Practices regulations (CGMPs). Sponsor organizations are expected to use appropriately designed facilities and to have in place phase-appropriate Quality Systems for clinical trial product manufacturing as well as for commercial product manufacturing.

This training course is designed to expose participants to a variety of topics including biologics product modalities, biopharmaceutical process development and manufacturing, current requirements for CGMP manufacturing of biopharmaceutical products and how to plan for CGMP implementation in your facility, and bulk plant design from a process/product perspective. The training course format uses a combination of lecture and case studies discussion.

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

PDA Biopharmaceuticals Training Courses

Agenda

  • Day 1
  • Day 2
  • Thursday, September 17, 2020

    Biopharmaceutical Product Modalities


    Biologic Process Development and Manufacturing

  • Friday, September 18, 2020

    CGMP Requirements and Implementation


    Facility Design Considerations

Trainers

Antonio Moreira
Antonio Moreira
University of Maryland, Baltimore County

Learning Objectives

  1. Explain the biopharmaceutical product and process development steps
  2. Describe and understand the key steps in typical biopharmaceutical manufacturing processes
  3. Understand CGMP requirements
  4. Develop a plan to implement CGMPs in your operations
  5. Identify the issues involved with designing a manufacturing facility for biological products under FDA CGMP compliance

Who Should Attend

This training course is intended for professionals who are involved in GMP manufacturing of clinical and commercial supplies of biopharmaceuticals.

Departments
  • Quality Control (Analytical)
  • Engineering
  • Manufacturing
  • Quality Assurance
  • Research and Development
  • Regulatory Affairs
  • Technical Operations
  • Facilities

Roles
  • Operator/Technician
  • Supervisor
  • Manager
  • Engineer

Registration Fees

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

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