Aseptic Fill & Finish for Biologics

Place
Imperial Riding School Renaissance Hotel, Vienna, Austria
Site visit
Dates
In-house Available
19 - 20 October 2020
Who should attend?

• Heads of production

• Shift leads

• QA reps or shop floor QA

• Project managers

• Operators in aseptic filling or visual control

Summary

This two-day training course provides an in-depth analysis of aseptic filling, one of the most challenging process steps in fill & finish of liquid formulated, biopharmaceutical drugs or lyophilized biopharmaceuticals. The training will offer real life examples and best practices for aseptic filling process management, qualification, validation & enviromental monitoring, plus three interactive workshops and lots of networking time with industry peers.

Learning Objectives

  • Three interactive workshops and group exercises
  • Learn what are the causes for contaminations in an aseptic filling process
  • Development of a fictive aseptic filling process (what technology is used, which equipment and assignment of the requirements?)
  • Let’s build an aseptic filling facility, what are the main areas to be considered?
  • How to set up a holistic aseptic filling concept?

Key Topics

  • Aseptic filling process management
  • New requirements by EMA and Annex 1
  • Holistic concept, techniques, interfaces
  • Validation and re-validation of aseptic filling steps
  • Environmental Monitoring
  • Visual control
  • Failure investigation & Practical tips
  • Examples of FDA findings for contaminations in aseptic products

Programme

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

Trainers

Dr. Ute Reichert

Independent Consultant, Former Head of Production (Sandoz)

Dr. rer. nat. Dipl. Ing Ute Reichert has more than 20-year experience in the biopharmaceutical and pharmaceutical industry, the last years as Head of an aseptic fill and finish production in Sandoz. During her work for other major companies as Lonza, Novartis, BI and Biogen, she collected the broad experience in varying positions in project management, process development, quality and production. As Project manager in contract manufacturing organizations, she was responsible for planning and project prosecution concerning timelines and budget and was one of the key persons to establish project management in a biotech company. As Head of quality the technical knowledge was completed by the legal framework, she was intimately involved in set up of business processes, definition of interfaces and stream lining of the processes to increase the efficiency and optimized working conditions. In Quality and in Production positions, one her main responsibilities was the training of employees.

Dr. Ute Reichert

Independent Consultant, Former Head of Production (Sandoz)

Dr. rer. nat. Dipl. Ing Ute Reichert has more than 20-year experience in the biopharmaceutical and pharmaceutical industry, the last years as Head of an aseptic fill and finish production in Sandoz. During her work for other major companies as Lonza, Novartis, BI and Biogen, she collected the broad experience in varying positions in project management, process development, quality and production. As Project manager in contract manufacturing organizations, she was responsible for planning and project prosecution concerning timelines and budget and was one of the key persons to establish project management in a biotech company. As Head of quality the technical knowledge was completed by the legal framework, she was intimately involved in set up of business processes, definition of interfaces and stream lining of the processes to increase the efficiency and optimized working conditions. In Quality and in Production positions, one her main responsibilities was the training of employees.

Tour info

Price per Delegate (EUR)

Public Training

1989.00

Online Training

1350.00
Register Now

Testimonials

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