Process Scale-up, Validation & Technology Transfer

Place
Vienna, Austria
Site visit
Dates
1 - 2 October 2020
Who should attend?

Pharmaceutical Technologists, Process Scientists and Process Engineers, Process Validation Specialists, CMO Managers, Technology Transfer Specialists, Manufacturing Management, Regulatory Affairs Managers, Quality Assurance Managers, Manufacturing Project Management

Summary

This two-day interactive course is intended to provide insight how state-of-the-artProcess 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 and workshop exercises will help you understand on how to translate theory into practice and overcome frequently faced challenges.

Aims

Learning & Key takeaways:

  • Understand industry approaches for Scale-up, Technology Transfer and PV applying QbD principles
  • Gain regulatory insights & guidance 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

Key Topics

  • 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

Programme

✓    Training materials will be provided in printed and digital form

✓    All delegates will receive printed and LinkedIn certificates

✓    5 hours of networkingwith industry peers

✓    Networking cocktail reception

Request Full Agenda

Trainers

Dr. Michael Braun

Director Late Stage Drug Product Development

Boehringer Ingelheim Pharma

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. In 2006 Michael joined Boehringer Ingelheim and worked in different positions with increasing responsibility within Pharmaceutical Development and R&D Project Management. Since 2014 he is Director Late Stage Drug Product Development and responsible for process development and scale-up of solid and liquid orals, parenterals and inhalative NCE products. This also includes product transfers to operations, launch support and preparation of submission documentation.

Dr. Michael Braun

Director Late Stage Drug Product Development

Boehringer Ingelheim Pharma

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. In 2006 Michael joined Boehringer Ingelheim and worked in different positions with increasing responsibility within Pharmaceutical Development and R&D Project Management. Since 2014 he is Director Late Stage Drug Product Development and responsible for process development and scale-up of solid and liquid orals, parenterals and inhalative NCE products. This also includes product transfers to operations, launch support and preparation of submission documentation.

Tour info

Testimonial

Price per Delegate (EUR)

1989.00
Register now

Request Full Agenda

For the detailed agenda with a full breakdown of the individual sessions fill out this form.

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Contact us

Lydia Makori

l.makori@symmetric.events
+421 222 200 543