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Process Scale-up, Validation & Technology Transfer
Process Scale-up, Validation & Technology Transfer

Course Description

This three-day training course is intended to provide insight into how state-of-the-art Process Scale-up, Technology Transfer, and modern Process Validation are tied together by applying Quality by Design principles. The regulatory requirements will be explained, and case studies will help you understand how to translate theory into practice and overcome frequently faced challenges.

  • QbD Principles during Process Development and Scale-Up
  • Scale-Up of Granulation and Tableting Process
  • Technology Transfer: Regulatory, Planning & Execution
  • Process Validation new guidance and requirements
  • Process Design Stage: Key input for Product and Process Quality
  • Process Performance Qualification
  • Continued Process Verification
  • Process risk assessment
  • Understand industry approaches for Scale-up, Technology Transfer, and PV applying QbD principles
  • Gain regulatory insights & guidance on how to realize Technology Transfers and PV
  • Explore proven best practices in Scale-up for solid dose manufacturing processes
  • Gain practical knowledge and tools during two interactive sessions and workshops
  • Take an excellent opportunity to discuss issues & challenges with industry peers and with an expert

Process Scale-up, Validation & Technology Transfer

October 28 - 30, 2024, Live Online Training
Regular price $2,250
Unit price
per 
Dr. Michael Braun

Dr. Braun is a trained pharmacist with 20 years of experience in Drug Product Development. He received his Ph.D. in Pharmaceutical Technology at the University of Bonn and started his career in pharmaceutical industry as Head of Pharmaceutical Development at Rentschler Pharma.

START TIMES

7:30 AM New York time

4:30 AM Los Angeles time

11:30 AM London time

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Course Description

This three-day training course is intended to provide insight into how state-of-the-art Process Scale-up, Technology Transfer, and modern Process Validation are tied together by applying Quality by Design principles. The regulatory requirements will be explained, and case studies will help you understand how to translate theory into practice and overcome frequently faced challenges.

  • QbD Principles during Process Development and Scale-Up
  • Scale-Up of Granulation and Tableting Process
  • Technology Transfer: Regulatory, Planning & Execution
  • Process Validation new guidance and requirements
  • Process Design Stage: Key input for Product and Process Quality
  • Process Performance Qualification
  • Continued Process Verification
  • Process risk assessment
  • Understand industry approaches for Scale-up, Technology Transfer, and PV applying QbD principles
  • Gain regulatory insights & guidance on how to realize Technology Transfers and PV
  • Explore proven best practices in Scale-up for solid dose manufacturing processes
  • Gain practical knowledge and tools during two interactive sessions and workshops
  • Take an excellent opportunity to discuss issues & challenges with industry peers and with an expert

"Trainer is very competent and has the complete knowledge of the matter."

– Senior Process Expert, B. Braun

"It is not at all frequent to find this grade of preparation and reaction to specific cases such as the ones presented. I'm enthusiastic! Thanks really."

– Tech Transfer Lead, Novartis

"Thank you for sharing all the links and informative material. Very professional organization and execution."

– Manufacturing Manager, Thermo Fisher Scientific

"The trainer was very knowledgeable about the topics and was able to answer all questions."

– Drug Product Subject Matter Expert, Pfizer

"Excellent work of the lecturer, good materials, clear explanations."

– Clinical Pharmacologist, Boehringer Ingelheim

Process Scale-up, Validation & Technology Transfer

Download the full training agenda to reveal complete session details, training takeaways, case studies, daily schedule, special features and full trainer bio.

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