This course will enhance the understanding of concepts related to current Good Manufacturing Practices (cGMPs), Quality Systems, and Risk Management and apply as appropriate to cell and gene therapy manufacturing. The course will walk through the regulatory framework, focus on quality principles as it relates to developing standards, controls, and risk management as it relates to cell and gene therapy manufacturing.

Snapshot

Format: Online

Hours: 24

Credits: 2.4 CEUs

When: Start anytime

Cost: $299 - $499

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Upon completion of this course, learners will be able to:

  • Define the general principles of cGMP, Quality Systems and Risk Management (GQR)
  • Understand and describe the regulatory framework and current thinking of FDA on cell, and gene therapy product manufacturing
  • Interpret and apply the appropriate GQR Standards for cell, and gene therapy product manufacturing

Module 1: Overview of FDA and the Regulatory Framework

  • Identify the different centers within FDA and their regulatory scope
  • Recall the regulations and guidance’s applicable to GQR
  • Recognize and appreciate tools (inspections and enforcement) in FDA to maintain compliance to regulations

Module 2: GMP and Quality Systems

  • Summarize the GMP principles
  • Summarize the Quality Systems approach
  • Describe how the GMP principles and Quality Systems approach work together to consistently produce a high quality product that is safe and efficacious

Module 3: Standards

  • Summarize the role of Pharmacopeias, ICH guidelines, ISO and ASTM standards in GQR
  • Describe and develop the standard (s) that will be appropriate for use in cell and gene therapy product manufacturing

Module 4: Controls

  • Understand and explain the importance of control on sourcing for raw materials, cell banks, cell-line etc. and qualification of suppliers and CRO’s
  • Learn about production and process controls, critical quality attributes, SOPs, batch records and validation protocols
  • Develop an appreciation for the sterilization and aseptic process validation methodologies
  • Describe Quality Control and Quality Assurance process

Module 5: Risk Management

  • Recognize the components of the Risk Management paradigm
  • Understand and describe the strategies used in Risk Management
  • Delineate the Risk Management Strategies applicable to cell and gene therapy product manufacturing

Module 6: Emerging Technology (e.g., MSC manufacturing)

  • Describe the Challenges in cell and gene therapy product manufacturing under GMP
  • Explain how GQR principles can facilitate the emerging technology development

Who Should Attend?

This is a foundational course for anyone planning for a job in cell and gene therapy manufacturing, including Research and Development. This course will provide the basic training needed to develop quality cell and gene therapy products.

Course Information

Course Number: 

0865-004

Course Date Info: 

Enroll at any time

Complete the course's required online quizzes and exercises within 90 days of issuance of course access details (i.e., a Welcome email containing the course URL, username and password)

Course format: 

Online

Course Fee(s): 

$499 regular registration

$299 NIIMBL members, Academia, and Government

Access the coupon code for Academia and Government

Cancellation/Refund Policy:
The Georgia Center will gladly issue full refunds for cancellations received in writing before the release of course access information. You may cancel your enrollment at any time during the course and receive a refund less a $35 administrative fee, provided that you have not accessed the online course material at all.

Grace GowdaGrace Gowda is the Program Director of the graduate studies in International Biomedical Regulatory Sciences within the College of Pharmacy, University of Georgia. Prior to joining University of Georgia, she worked in the pharmaceutical industry for many years where she held various leadership positions within regulatory affairs.

Grace has a Ph.D. in Pharmacology and Toxicology from the University of Texas at Austin, a Masters in Pharmacy from Nagpur University and Bachelor’s in Pharmacy from University of Madras, India. Her 25+ years of Pharmaceutical experience includes basic research, clinical research and trials, product development, targeted drug delivery, registration and maintenance of products and regulatory policy. She has Regulatory Affairs Certification and is passionate in developing and mentoring the next generation of regulatory professionals.