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  • WEBINARS/eLEARNING
    • Live Courses/Webinars
    • On-Demand Courses/Webinars
    • By Category
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      • Manufacturing
      • Medical Devices
      • Regulatory
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      • DIGR-ACT: Critical Thinking Skills for Clinical Trials
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HomeClinical Trials & Good Clinical Practices (GCP) TrainingImproving Product Quality During Technical Transfer: Minimizing Risk, Maximizing Results

Improving Product Quality During Technical Transfer: Minimizing Risk, Maximizing Results

Teachers
Eric Good
Category:
Clinical Trials & Good Clinical Practices (GCP) Training/ Manufacturing & Good Manufacturing Practices (GMP) Training/ On-Demand Courses/ Research & Development/
knowledge transfer
Clear

— OR —

Duration: 60 minutes
On-Demand
Includes handouts
  • Course Description
  • Who Should Attend
  • What To Expect

Course Description

OVERVIEW

Successful technology transfer in the manufacturing of pharmaceutical products is a stressful and expensive process that is fraught with risk. Whether you are moving from early R&D to producing product for clinical trials, scaling up commercial manufacturing, changing your process, or moving to an outsourced model, careful planning and execution is needed. While firms have been doing this for as long as regulated pharmaceutical products have been made, there is little guidance and few have an optimal process.   The design of tech transfer is difficult enough, but the execution of that transfer is a complex process involving the interactions of many disciplines across an organization. Documents, data, institutional knowledge, and cross-functional cooperation are all critical. So the question remains…where to start?

This course will give you the tools to understand pharmaceutical technology transfer from the planning through implementation phase, plus offer clear, actionable steps you can take to ensure success. You will receive best practices and learn from first-hand anecdotal experience. As you progress through the interactive session, you will be encouraged to ask questions and engage in discussion. Additionally, you will receive job aids to assist you and your colleagues in your efforts to ensure pharmaceutical manufacturing technology transfer success.

LEARNING OBJECTIVES

During the session, you will learn:

  • The definition of Technology Transfer and its many applications
  • Planning for tech transfer the “right way,” using “Calculated Risk Reduction” and other tools to ensure your bases are covered
  • Common pitfalls and best practices: what to do, and what not to do
  • Implementation strategy: When, What, and How
  • Ways to ensure optimal planning and execution using actionable job-aids

Who Should Attend

WHO SHOULD ATTEND

This course will be of benefit to anyone involved in product technical transfer on a global or domestic scale. Additionally, those who need to be able to communicate internally with project management or quality personnel or vendors responsible for product technical transfers will find this course extremely beneficial. Relevant functions include:

  • Product, process, and formulation development
  • Project management
  • Analytical development
  • Manufacturing roles
  • Quality assurance
  • Quality control
  • Regulatory affairs

What To Expect

WHAT TO EXPECT

HOW TO PARTICIPATE

This webinar is offered on-demand. With your course purchase, you may view the previously recorded live session at your convenience (available for 30 days). Access to the on-demand webinar will be made available via email within 1 business day after your purchase. To access the course, you need only a computer with internet access and the log-in credentials.

THE TRAINING PLATFORM

Our webinar platform combines the convenience of online training with the live interactivity of the classroom. Quizzes, case studies, break-out sessions, and assessments are often incorporated into the training . Other ancillary materials can be downloaded from the “Handouts & Resources” area in the virtual classroom. Each course purchase includes a completion certificate issued to the participant after the course.

USER AGREEMENT

Your registration fee for a single participant entitles you to one telephone dial-in and one online course log-in per site. Course testing capabilities, stored results for training records, and completion certificates are available for only one registrant per single participant course purchase. For multiple participants, please purchase more than one registration or consider our 5 or 10 participant packages.

Is this course right for me? We’d be happy to help you select the right training course to meet your needs.
Contact us at 215-675-1800, Option 3 (9am – 5pm EST, M-F) for assistance.

About Instructors

Eric Good
Dr. Good has spent his years in industry in Manufacturing, Project Management, and for the last 12 years, Quality. Throughout his career, he has helped remediate Consent Decrees, Warning Letters and many FDA Observations. He has worked with Fortune 500 Pharmaceutical and Biotechnology companies and solved complex, multi-operational compliance issues. Dr. Good has spoken professionally at ISPE and PDA regional and national meetings on the subject of Compliance risk and solutions.

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Clear

— OR —

Duration: 60 minutes
On-Demand
Includes handouts

CATEGORIES

  • Coronavirus / COVID-19 (4)
  • Clinical Trials & Good Clinical Practices (GCP) Training (110)
  • Introductory Pharma Courses (18)
  • IT & Data Integrity for Pharma (33)
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Upcoming Live Courses

  • China GCP 2020: Understanding and Implementing New Compliance Requirements
  • How to Prepare for FDA Guidance on Computer Software Assurance (CSA) in 2021 – A Two Part Primer
  • It is Finally Here! Update to the ISO Medical Device GCP Standard: ISO 14155:2020
  • Preparing for Changes to ICH GCP E6(R3) and ICH E8(R1) – Readying for Risk Mitigation

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The Life Science Training Institute helps pharma, biotech, and medical device companies build knowledgeable, compliant workforces by providing training from drug discovery through commercialization. We are dedicated to advancing careers of those working to develop new therapies and to protect patient safety.

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