Phase-Appropriate GMPs: A Regulatory Roadmap

Life Sciences, Pharmaceutical Regulation, Pharmaceutical, Pharma Manufacturing & Supply Chain,
  • Tuesday, April 14, 2020

This webinar will focus on current best practices for mapping the regulatory framework during R&D, investigational phases, and to commercial manufacturing.

The speaker will give you a look into how a CDMO navigated an industry anecdote that drove the creation of company policy and the development of the Lifecycle Matrix tool. A holistic approach was used to build a roadmap of product development & regulatory activities based on cGMPS and ICH requirements. The approach was to layer the manufacturing processes and activities with best practices for achieving compliance. As the product development progresses through the phases and then into commercial manufacturing, the regulatory requirements and expectations increase.  Using this tool during product development can provide a regulatory strategy map that navigates hurdles prior to regulatory agency reviews.

Taking a proactive approach to exploring what control strategies are expected, and subsequently required, will provide a streamlined development approach ensuring the safety and quality of the product. A phase-appropriate cGMP operating model is highly relevant for companies that have a high level of externalization of their R&D and early investigational development activities. This approach is characterized by an accumulation of product/process knowledge, increasing application of good manufacturing practices, and escalating quality controls across the product lifecycle.

During product development, many variables are still being established such as the knowledge of the product and characterization, the components, and methods of manufacture and testing.  Early phase development allows for flexibility based on the scientific data in a risk-based approach. Increasing process controls are detailed per activity based on the investigational phase.  Qualification processes are then layered into the product development which will provide a primer for validation activities during late phase and process performance qualification (PPQ) batches.

Explore how Cytovance Biologics created and use this tool to maintain a uniform interpretation of company policies, client’s processes and global regulations. By building a roadmap based on cGMP activities that outline the level of scientific understanding, layering in parallel the compliance expectations, the development of control strategies navigates the product to ensure that requirements are met.


Dawn L. Wofford, Cytovance Biologics, Director Regulatory Affairs

Dawn L. Wofford is on a mission to help biopharma companies navigate the global regulatory landscape by delivering compliance and regulatory solutions from product development, clinical trials, product realization, commercial manufacturing and post-marketing activities.

Trained as an archaeologist/anthropologist, she has a unique 15-year background in Regulatory Affairs and Quality Compliance in the biologics, tissue, pharmaceutical and medical device industry. Dawn’s therapeutic areas of expertise include cellular therapy, regenerative medicine, ophthalmology, oncology, hematology, and women’s health.

Dawn is currently the Director, Regulatory Affairs of Cytovance Biologics, a CDMO in Oklahoma City.  In this role, she promotes a culture of quality excellence by implementing innovative solutions through the regulatory roadmap of the product’s lifecycle.

Dawn received a B.A. in Anthropology/Archaeology and a B.A. in Sociology from Hawaii Pacific University. Dawn is a certified Quality Auditor (ASQ), a certified Manager of Quality/Organizational Excellence (ASQ) and participates on various industry working committees for Pharma & Biopharma Outsourcing Association (PBOA), International Society for Pharmaceutical Engineering (ISPE) and Parenteral Drug Association (PDA).

Message Presenter

Who Should Attend?

This webinar will appeal to pharmaceutical and biotechnology professionals working for CDMOs & CMOs, with relevant job titles including:

  • Development Scientists
  • Regulatory Professionals
  • Quality Professionals

What You Will Learn

  • Introduce the regulatory roadmap for the product lifecycle: from R&D, approaches during clinical phases and requirements for commercial manufacturing
  • CDMO approach: common understanding of risks, expectations & activities
  • GMP requirements & expectations
  • Framework for risk-based quality system
  • Examples of lifecycle matrix

Xtalks Partner

Cytovance Biologics

Cytovance® Biologics is a leading biopharmaceutical Contract Development and Manufacturing Organization (CDMO) that excels in the rapid and cost-effective development and manufacture of large molecule APIs from both mammalian cell culture and microbial fermentation such as monoclonal antibodies, fragment antibodies, bispecifics, enzymes, fusion proteins, vaccines and other biological products including plasmid DNA and cell-based therapeutics. In addition to our clinical and commercial cGMP API manufacturing services, Cytovance offers well integrated development services supporting the entire product lifecycle including cell line development, cell banking, microbial strain development, process and analytical development, and process characterization.  A centralized, responsive program management team coordinates all critical CMC activities for each client program around raw materials management, QC testing, ICH stability studies, and regulatory support. Our 140,000 sq. ft. state-of-the-art facilities in Oklahoma City are designed to meet U.S., EU, and other global regulatory standards.

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