Understanding of the Regulatory Requirements Governing Biopharmaceutical

Live Webinar

  • 90 minutes

The primary difference between biopharmaceuticals and traditional pharmaceuticals is the method by which the drugs are produced: Biopharmaceuticals are manufactured in living organisms such as bacteria, yeast and mammalian cells, whereas traditional pharmaceuticals are manufactured through a series of chemical synthesis.

Biopharmaceutical products make up an increasing share of new approvals from the US Food and Drug Administration. Today, biopharmaceuticals generate global revenues of $163 billion, making up about 20 percent of the pharma market. It’s by far the fastest-growing part of the industry.

Join this session by expert speaker Kelly Thomas, where she will provide a detailed discussion on the topic of validation.

Session Highlights:

Topic 1: BioPharmaceutical Regulatory Requirement Review

  • 21st Century Cures Act

  • 2017 FDA Final Guidance for Labeling Biosimilar Products

  • ICH Q8

  • ICH Q10

Topics 2: FDA’s Emerging Technology Program

  • The FDA has been at the forefront of modernizing the way drugs are made, including introducing the Emerging Technology Program.

Topic 3: Validation Overview

  • Regulatory guidance overview

  • The product/process life cycle data

  • Example Protocol review

Why You Should Attend: 

Biopharmaceutical companies best positioned to succeed in tomorrow’s market will be those that master a broad set of technical and operational capabilities; as well as, ensure adherence to cGMP compliance requirements. Attendees of this course will gain a clear understanding of the regulatory requirements governing biopharmaceuticals.

Who Should Attend:

  • Production

  • QC Micro

  • Engineering & Validation

  • Facilities / Maintenance

  • Quality Assurance

*You may ask your Question directly to our expert during the Q&A session.

** You can buy On-Demand and view it as per your convenience.

Kelly Thomas

Kelly Thomas

Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.

Utilizing strategic thinking, risk based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.

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