Biopharmaceutical Analytics – Regulations and Validation

Biopharmaceuticals and traditional pharmaceuticals drugs have completely different approach to how they are produced. Biopharmaceuticals use living organisms such as bacteria, yeast and mammalian cells to manufacture drugs, whereas traditional pharmaceuticals are manufactured through a series of chemical synthesis. Here is some Biopharmaceutical Analytics – it is the fastest-growing part of the FDA regulated industry. An increasing share of new approvals from the US Food and Drug Administration is from Biopharmaceuticals. Today, biopharmaceuticals makes up about 20 percent of the pharma market generating global revenues of around $163 billion. This is only predicted to get bigger. Quality functions on the other had are struggling to keep up with the rising demands of regulators, primarily the US FDA. 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, multiple quality standards and regulatory regimes with the increasing demand from global markets (beyond the United States, European Union, and Japan) is adding to the complexity.

Why You Should Attend:

Only those Biopharmaceutical companies that have mastered a broad set of technical and operational capabilities will thrive. They must be able to ensure adherence to cGMP compliance requirements. Join this webinar to understand clearly and without doubt the regulatory requirements governing biopharmaceuticals. This course will also discuss validation in detail.

Areas Covered in the Session :

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 Should Attend:

  • Quality Assurance Departments
  • Quality Control Departments
  • Research and Development Departments
  • Manufacturing Departments
  • Engineering Departments
  • Production Departments
  • Validation Departments
  • Facilities / Maintenance
  • Microbiologists

FDB3201

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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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance
.