Process Scale-up & Tech Transfer for Injectables
Process Scale-up & Tech Transfer for Injectables

Course Description

This three-day online training course is providing vital practical insights into QbD implemented Process Scale-up, Technology Transfer, and Process Validation for sterile injectable dosage forms.
  • QbD Principles During Process Development and Scale-Up
  • Process Scale-Up of Sterile Injectable Dosage Forms
  • Technology Transfer: Regulatory, Planning & Execution
  • Process Validation New Guidance and Requirements
  • Aseptic Processing
  • Media Fills
  • Process Risk Assessment
  • The Future of Aseptic Manufacturing
  • Understand industry approaches for Scale-up, Tech Transfer and PV applying QbD principles
  • Explore proven best practice in Scale-up and Tech transfer for sterile injectables
  • Take an excellent opportunity to discuss issues and challenges with industry peers
  • Gain practical knowledge from case studies

Process Scale-up & Tech Transfer for Injectables

10 - 12 June 2024, Live Online Training
€1.850,00
Dr. Laura Buttafoco

Laura has an extensive industrial experience in the development of drug products for the worldwide market, from scratch to registration, in accordance with GxP and ICH requirements.

START TIMES

9:00 AM Vienna Time

8:00 AM London Time

3:00 AM New York time

12:00 AM Los Angeles time

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Course Description

This three-day online training course is providing vital practical insights into QbD implemented Process Scale-up, Technology Transfer, and Process Validation for sterile injectable dosage forms.
  • QbD Principles During Process Development and Scale-Up
  • Process Scale-Up of Sterile Injectable Dosage Forms
  • Technology Transfer: Regulatory, Planning & Execution
  • Process Validation New Guidance and Requirements
  • Aseptic Processing
  • Media Fills
  • Process Risk Assessment
  • The Future of Aseptic Manufacturing
  • Understand industry approaches for Scale-up, Tech Transfer and PV applying QbD principles
  • Explore proven best practice in Scale-up and Tech transfer for sterile injectables
  • Take an excellent opportunity to discuss issues and challenges with industry peers
  • Gain practical knowledge from case studies

"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 & Tech Transfer for Injectables

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

Medical-Devices-Certificate-Course

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