Overview

This training will introduce the concepts associated with implementing a carefully defined technical and business governance programs along with clearly defined R&D to site transfer steps for successful implementation. It will cover the concepts associated with transferring the scientific technology needed to manufacture the product, processes to ensure the receiving manufacturing facility is ready for the product and tools and templates to help capture the knowledge. 

At the end of the session, you should be able to:

•   Define technology transfer

•   Identify elements of the business process framework for managing technology transfers

•   Identify New Product transfer process

•   Explain benefits of technology transfer

•   Determine elements of a successful technology transfer

Why should you attend :

Successful transfer of pharmaceutical products and their processes is critical to the successful launch. Its success ensures that products of the highest quality are delivered to the patients along with meeting the business demands of the company. However execution of that transfer is complex involving the interactions of many disciplines across an organization. It depends both on the careful development, management, and transfer of technical and business knowledge along with the development of steps to define the formal transfer of that knowledge from R&D documents and systems to commercial manufacturing documents and systems.

Webinar Takeaway

  • The importance of technology transfer
  • The use of a technical review system to update and review technology knowledge obtained during drug product development
  • The use of a Product Strategy Review system to review important business aspects in preparation for transfer
  • Tools and Templates used for technology transfer 

Who will Benefit

•  Senior quality managers

•  Quality professionals

•  Regulatory professionals

•  Compliance professionals

•  Production supervisors

•  Manufacturing engineers

•  Production engineers

•  Process owners

•  Quality engineers

•  Quality auditors

•  Development professionals

•  Senior development managers

Industries who can attend

This course is designed for people tasked with developing, filing, and manufacturing pharmaceutical products especially small molecule oral dosage forms. This includes individuals that have responsibilities for formulation development, scale-up, filing, and commercial manufacture of dosage forms as well as maintaining the high quality of those products. Following personnel will benefit from the course

Faculty Steven Laurenz

Steven Laurenz– Chemical Engineering M.S. – Michigan State University. Expertise: Over 25 years of technical leadership experience in product development, process development, technology transfer, and process optimization. Skilled in taking new products from early laboratory stage to successful manufacturing launch. Expert in integrating Quality by Design and risk management into product development. Experience in establishing a Quality System for a R&D Quality Assurance organization.

Faculty Steven Laurenz

Choose a Purchase Options

$289

Recorded Access Single - 6 month Access

You'll have access to one log-in for an archived recording of the entire 60-minute webinar, including the Q&A period, for 1 participant. You can log in any time of day or night. You'll also receive all presentation materials, plus an audio recording and transcript for the entire session. Delivery is approximately 48 hours after the session

$399

MP3 Download (DVD)

Within 48 hours delivered - Lifetime Access ,Audio recording of a webinar and reference manual delivered by download. Listen anytime on any compatible device.