Join Lachman Vice President John McShane and Executive Director Keith Lamb with Arnold & Palmer attorneys Howard Sklamberg and Phillip DeFedele for a live webinar, FDA Manufacturing Compliance and Inspections for Cell and Gene Therapies and Other Innovative Biologics. The 1 hour session will be held on September 15 at 1:00 pm EST.

Cell and gene therapies continue to offer promising results, with the power to cure and mitigate serious, often previously incurable diseases and conditions. However, these novel therapies are highly complex—and because they are derived from biological sources, manufacturers continue to face a series of unique challenges during product development and commercialization. This webinar explores this critical topic with expertise from the industry’s top regulatory and legal experts, who will address current GMP requirements, FDA inspections, manufacturing challenges, quality agreements, and other practical considerations related to cell and gene therapy products.

Designed for pharmaceutical companies, academic institutions, and private equity and investment firms, this learning experience offers best practices to simplify the process, real-world examples that deliver proven results, and challenges, concepts, and approaches to the compliant manufacture of other novel biopharmaceuticals.

The 1 hour session will also delve into:

  • Long-term benefits of making process, equipment, and facility decisions early in the development lifecycle
  • The importance of having a robust QMS and framework that can be matured through the lifecycle to ensure it’s ready for licensure
  • How to assess your QMS, whether your own internal quality systems or one developed by a third party
  • Why you need to consider your supply chain, with tips for establishing an effective approach for each element
  • Potential issues associated with Health Authority Inspections and how to avoid them

We look forward to seeing you there!

Webinar Date and Time:

Click Here to Register for September 15, 2022, from 1:00 – 2:00 pm EST

About the presenters:

  • John McShane, VP, Biologics and Manufacturing Data Integrity, Lachman Consultant Services, Inc.
  • Keith A. Lamb, Executive Director, Lachman Consultant Services, Inc.
  • Howard Sklamberg, Partner, Life Sciences and Healthcare Regulatory, Arnold & Porter
  • Phillip V. DeFedele, Senior Associate, Life Sciences and Healthcare Regulatory, Arnold & Porter