Process Scale-up & Tech Transfer for Injectables

Place
Online training
Site visit
Dates
Next Dates
In-house Available
23 - 25 November 2020, 9:00 – 12:45 CET
Who should attend?

Injectables Technologists, Process Scientists, Process Engineers, Process Validation Specialists, CMO Managers, Technology Transfer Specialists, Manufacturing Management, Regulatory Affairs Managers, QC & QA Managers

Summary

This two-day online trainingcourse is providing vital practical insights into QbD implemented Process Scale-up, Technology Transfer and Process Validation for Sterile Injectable Dosage Forms.

Learning Objectives

  • 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

Key Topics

  • 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
  • Process Design Stage
  • Process Performance Qualification
  • Continued Process Verification
  • Process risk assessment

Programme

  • Training materials provided in printed and digital form
  • All delegates will receive printed and LinkedIn certificates
  • 5 hours of networking with industry peers and trainer
  • Networking cocktail reception
Request Full Agenda

Trainers

Dr. Laura Buttafoco

CEO

Protea

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. 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 overthe-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 independent ICH-GCO and GLP auditor in clinical trials.

Dr. Laura Buttafoco

CEO

Protea

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. 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 overthe-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 independent ICH-GCO and GLP auditor in clinical trials.

Tour info

Price per Delegate (EUR)

Online Training

1350.00

Public Training

Register Now

Testimonials

Request Full Agenda

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Contact us

Lydia Makori

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