FDAnews Announces — Best Practices for Effective Pharma Technology Transfer: From R&D to Clinical to Commercial Webinar, April 25, 2016

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Technology transfer of a pharmaceutical manufacturing process to either an outsourced or partner site is a significant undertaking, one that needs to be accomplished quickly and efficiently. On April 25 industry expert Susan J. Schniepp provides a thorough analysis of the most important do’s and don’ts drug manufacturers need to be aware of as they go through this thorny thicket of commercial development.

Best Practices for Effective Pharma Technology Transfer:
From R&D to Clinical to Commercial
April 25, 2016 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/effectivetechnologytransfer    

Technology transfer of a pharmaceutical manufacturing process to either an outsourced or partner site is a significant undertaking, one that needs to be accomplished quickly and efficiently.

In order to be successful and to achieve full product realization several functions at both the sending and receiving site must be employed.

On April 25 industry expert Susan J. Schniepp provides a thorough analysis of the most important do’s and don’ts drug manufacturers need to be aware of as they go through this thorny thicket of commercial development.

This webinar will focus on the critical areas for a smooth handoff of technology, which include:

  • Transfer from R&D to Clinical Development
  • Transfer from Clinical Development to Commercial
  • Transfer Between Company Facilities
  • Transfer to Contract Manufacturer

Attendees will leave with a clear understanding of the following areas which are essential for maximizing the effectiveness of technology transfer:

  • Robust information exchange
  • Planning and project management
  • Transfer of analytical assays
  • Small-scale verification at receiving site
  • Pre-GMP engineering runs
  • GMP runs

This knowledge forms the basis for the manufacturing process, control strategy, process validation approach and ongoing continual improvement.

Meet the Presenter:
Susan J. Schniepp is a fellow at Regulatory Compliance Associates, Inc. As a pharmaceutical quality assurance thought leader with 35 years’ experience, Sue has held leadership roles in industry at Allergy Laboratories, Inc., OsoBio Pharmaceuticals, LLC, Searle, Abbott and Hospira. She has served PDA as a member of the Board of Directors, PDA / FDA Joint Regulatory Affairs Conference Chair, conference presenter, and Chair of the PDA’s Regulatory Affairs / Quality Advisory Board, and was awarded PDA’s Distinguished Service Award in 2008.

Who Will Benefit:

  • Compliance officers
  • Engineering and design controls teams
  • Executive management
  • General/corporate counsel
  • Managers
  • Manufacturing directors and supervisors
  • QA/QC personnel
  • R&D staff
  • Regulatory/legislative affairs professionals
  • Risk management specialists

Webinar Details:
Best Practices for Effective Pharma Technology Transfer:
From R&D to Clinical to Commercial
April 25, 2016 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/effectivetechnologytransfer

Tuition:
$287 per site

Easy Ways to Register:
Online: http://www.fdanews.com/effectivetechnologytransfer
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

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Michelle Butler
FDANEWS
+1 (703) 538-7665
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