Biopharmaceutical Analytics: Regulations and Validation

01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 90 Minutes

Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar

"Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations"

Regulatory requirements governing biopharmaceuticals

Description

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.

Quality functions are struggling to keep up with the rising demands of regulators, primarily the US Food and Drug Administration. The industry has received an unprecedented number of warning letters and remediation programs in the last five years, and scrutiny is unlikely to decrease. Furthermore, the increasing relevance of global markets (beyond the United States, European Union, and Japan) is adding the complexity of multiple quality standards and regulatory regimes.

Why should you 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.

This course will also provide a detailed discussion on the topic of validation

Areas Covered

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

Who will Benefit

•     Production
•     QC Micro
•     Engineering & Validation
•     Facilities / Maintenance
•     Quality Assurance

Industries who can attend

This 90 minute online course is intended for professionals in the Pharmaceutical and Biopharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel


Speaker Profile

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.

Back to Top