COURSE ID 2904

Pharmaceutical Technology Transfer and Project Management

AVAILABLE LIVE ONLINE
Date(s) and Time:
May 1, 2024 - May 2, 2024
9:00 am EDT - 1:30 pm EDT
Duration: 8 Hours

Can't attend the live course?
Select the on-demand option during registration, and we will automatically send you the recording when it is ready.

Course Instructor

Mukund (Mike) Yelvigi

Walter G. Chambliss, Ph.D.

Early-Bird Offer

Limited Availability until April 11, 2024

$ 1200
Price
$ 1300
Discounts: We offer a 10% group discount when you register 2 or more attendees (up to 10). Contact us for groups over 10.

Course description

View Course Outline

Gain a fundamental comprehension of technology transfer in the pharmaceutical industry, including the transfer of analytical methods, quality control standards, packaging components/operations, and various dosage forms from R&D to manufacturing. This course provides an overview of scale-up and technology transfer of solid dosage forms, injectables, and semisolids.

During the course, we will delve into the challenges of transfers within and outside a company, including transfers to/from international sites and third parties. Best practices to avoid common pharmaceutical technology transfer issues will be discussed.

We will address issues affecting changes to batch size, formulation, packaging components, site of manufacture, manufacturing process, analytical methods, specifications, and processing equipment changes, with practical examples from experienced speakers.

The importance of technology transfer teams and the roles and responsibilities of project managers and team members will be emphasized.

Additionally, you will engage in interactive case studies, based on real-world examples, to develop collaborative strategies and plans to execute complex transfers with short timelines. The course is designed for professionals involved in technology transfer of prescription (innovator and generic) and over-the-counter drug products.

Upon completion of this course, you will be able to:

  • Utilize the interactive processes involved in technology transfer and describe the approaches used to transfer packaging components, analytical methods, and a wide variety of dosage forms
  • Describe the critical issues surrounding technology transfer and how to plan for success
  • Classify post-approval changes according to their potential impact on product quality and performance
  • Use relevant regulatory guidance documents to develop research and regulatory strategies
  • List key issues in internal and third-party transfers
Register

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Who should
attend?

This training is designed for professionals in the pharmaceutical industry. It will be especially valuable to personnel and management, including senior management, in these areas:

  • Project Managers and Operations Management
  • Formulation Development
  • Process Development/Validation
  • CDMO Business Development
  • Manufacturing, Logistics and Technical Support
  • Analytical Methods Development
  • Quality Control/Assurance
  • Regulatory Affairs
  • Package Development/Package Engineering
  • Operations Management/Logistics

You will benefit by gaining a better understanding of the complexities of technology transfer in the pharmaceutical industry. The course covers transfers of small molecule drug products, not biotechnology, vaccines, or medical device products.

Course Instructor

Mukund-(Mike)-Yelvigi

Mukund (Mike) Yelvigi

Principal and Managing Partner, Center for Pharmaceutical Integration, LLC

Mukund (Mike) Yelvigi’s Courses
Walter-G.-Chambliss

Walter G. Chambliss, Ph.D.

Professor Emeritus and Research Professor Emeritus, Pharmaceutics and Drug Delivery, University of Mississippi

Walter G. Chambliss, Ph.D.’s Courses

Accreditation

Team Training

When you need on-site attention, we’re not just here to help, we’re there to help—right by your side.

Individual courses are remarkably effective. But sometimes when you have a specific need, it helps to have expert guidance right in the room with you and your team.

In that case, we’re happy to design a custom training for your entire team, whether online—or on-site.

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