Technology Transfer for Pharma & Biotech

Date to be announced

Price available after dates are announced

TRAINING TIMES

TBDVienna
TBDLondon
TBDNew York
TBDLos Angeles

LEARNING OBJECTIVES

Understand industry current approaches for technology transfer

Get valuable insight on the do’s and don’ts for successful technology transfer starting from practical examples

Explore proven best practices for technology transfer of different drug product formulations

Understand why implementation of QbD principles is essential for the successful completion of a case study

Gain practical knowledge from interactive sessions and case studies

Take the opportunity to discuss issues and challenges with colleagues and the trainer

KEY TOPICS

QbD Principles during Process Development and Scale-Up

Control Strategy and Risk Management

Technology Transfer Challenges

TRAINER

Dr. Laura Buttafoco

Protea, CEO

Laura has extensive industrial experience in the development of drug products for the worldwide market, from scratch to registration, in accordance with GxP and ICH requirements. This includes writing and revision of CMC regulatory documentation for the drug substance and drug product used in veterinary and human hormonal therapy, antibiotics, statins, vaccines and over-the-counter medications. Laura’s experience brings a unique combination of scientific background and effective communication skills that are well-matched with her international perspective and experience. She was responsible for the outsourcing of all analytical and processing activities related to the development, scale-up, tech transfers and validation of pharmaceutical products within multidisciplinary teams managing in DSM, Janssen and Disphar. Laura also has in-depth and direct experience in collaborating and managing CROs and CMOs in culturally diverse environments, mostly within Europe and Asia (especially India and China). She is certified as an independent ICH-GCO and GLP auditor in clinical trials.

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