Manufacturing of Sterile Medicinal Products MasterClass - US edition

13-14 February, 2025

Aseptic Filling of Biologics & Finish

The aseptic filling process is the highest standard in the pharmaceutical industry and more in demand than ever due to the advance of biological active ingredients.

13-14 February, 2025, Virtual
Time Zone: Eastern Standard Time (EST) - UTC05:00

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Key learnings

Annex 1

Regulatory requirements and whats new by Annex 1

Technical

Technical equipment

Critical points

Critical points in the aseptic filling process

CCS

Contamination Control Strategy (CCS) and aseptic processing

Aseptic Filling

Single-used systems in aseptic filling

Digitalization

Digitalization and trending, considering CCS

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Overview

The aseptic filling process is the highest standard in the pharmaceutical industry and more in demand than ever due to the advance of biological active ingredients. The challenge is not only the different batch sizes from clinical batches to market supply, but also the constantly increasing demands (Annex 1). What measures need to be taken to manufacture sterile products, what needs to be taken into account and is sterile ultimately free of any micro-organisms? An interesting question, the answer is given in this seminar.

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Trainer

Dr. Ute Reichert

CEO
IBio-Technology & Pharma Consulting

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.

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Reasons to attend a masterclass

Practical knowledge

Venture into undiscovered territories and gain inspiration through collaboration

Interactivity

Boost your professional skills by directly engaging with domain experts

World-class trainers

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Networking

Build a top-notch community and advance your career

Who should attend img RECOMMENDATION

Who should attend?

-Quality control

-Quality assurance

-Production

-Transfer managers

-Compliance manager

Ticket options for you

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*minimum of 10 participants

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Testimonial

Our success stories

"High attention to detail in course content and very well delivered"

Simon Halsey

Product Development Manager
Essentra Packaging
United Kingdom

Our success stories

"Very good training led by two knowledgeable and open experts. Excellent insight given on many complex topics. Interactive and highly useful"

Aurelie Vivicorsi

USP PD Team Manager
Celonic AG
Switzerland

Our success stories

"Great course, impressed with the knowledge of the trainers and ability to answer wide variety of questions!"

Emilia Szwej

Manager, Senior Investigator
MT Sword Laboratories (BMS)
Germany

About GLC

Global Leadership Conferences began as an ambitious dream by three founders ten years ago. Today its an international series of interactive events, exploring the hottest topics in critical fields. Each year, thousands of professionals join us to challenge the status quo and learn innovative ways to create new solutions in Finance, Pharmaceutical, HR, Health & Safety, and Energy.

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