cGMP Annex 1 Lyophilization Technology

22-23 May with easy access on Zoom

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cGMP Annex 1 for Lyophilization Technology

The revised EMA Annex 1, unveiled in 2022 and effective from 2023, introduces crucial requirements for lyophilizers this year.

We are pleased to announce the cGMP Annex 1 for Lyophilization Technology Online Event, scheduled for 22-23 May, is designed to navigate the intricacies of the recent EMA revised Annex 1 guidelines, particularly focusing on lyophilization technology. This webinar is your essential resource for understanding and successfully implementing the new requirements in your organization before getting audited by regulators.
After each presentation, we allocate 5 minutes for an interactive Q&A session, enabling online participants to engage in problem-solving discussions.

Some of the topics to be discussed will include:

● The fate of manual loading and unloading processes
● Hold time validation of the lyophilization process
● Automating lyophilization processes across industry
● Automated loading and unloading of vials manual operations vs. Automations
● Is Annex 1 forcing the use of automated methods?
● Can we retrofit our currently used freeze dryers?
● Lyophilizers sterilization frequency

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SEPRO PHARMENEX

We are a dynamic team of junior and senior professionals, all with a primary emphasis on the pharmaceutical industry and its highly specific aspects of Quality. We always remain open to changing statutory requirements, progressing regulatory procedures, and technological advancements. Located in the southwestern part of Germany, between Heidelberg and the French border, we are only a stone’s throw away from pharmaceutical hotspots such as the Basel region, Strasbourg, or the Rhine-Main Area, home to many global players. We provide support to pharmaceutical manufacturers to establish, expand, or refurbish their manufacturing capacities for Drug Substances and Drug Products in Western Europe and the Rest of the World (ROW). Our focus and experience lie in Fill & Finish processes and production equipment.

Event Ticket Price

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€355

Two Days Access

  • Full Online Event Access

  • Q&A Chat

  • Post-Event materials

  • Digital Certificate of Attendance

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€595

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Intro Video

Why to Join this Webinar

This webinar is designed for convenient access from any location, ensuring easy participation and invaluable insights into navigating the complexities of pharmaceutical regulation.

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High Value Learning

Provides essential knowledge and insights crucial for professional growth and success. Stay updated with us wherever you are.

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Query Solving

Our expert panel excels in resolving queries, providing comprehensive solutions to address various challenges effectively.

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Networking Preople

Networking with peers allows individuals to establish valuable connections, fostering opportunities for collaboration and growth.

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Great Speakers

Our renowned experts will impart practical knowledge tailored to meet the current needs of professionals, ensuring relevance and applicability.

Event presenters

Meet Our Speakers

Richard Denk, CH

Senior Consultant, Aseptic Processing & Containment at Skan AG

Igor Gorsky, US

Principal Process Validation Consultant at ValSource Inc.

Jens Gemmecker, DE

Team Leader Fill & Finish at Pharmaplan GmbH

Rolf Lenhardt, DE

Managing Director at Teclen GmbH

Oliver Stauffer, US

CEO at Packaging Technologies & Inspection (PTI)

Tino Feidler, DE

Key Account Manager at KÖGEL FILTER GmbH-CONTECMA

Varadharaj Vijayakumar, DE

Senior Subject Matter Expert-Aseptic Fill Finish/Freeze drying at WuXi Biologics

Carlos Amor, ES

Freeze Drying Expert and Founder at Lyoptimus Thermodynamics S.L.

Dr. Andrea Weiland-Waibel, DE

Owner of Explicat® Pharma GmbH
Schedule Dates & topics

Event Schedule

12:05 - 12:50

Loading and unloading of freeze dryers & today's requirements. Are adaptations and a corresponding conversion of the systems possible and sensible, or is a new system the better choice?

  • The presentation contains examples of systems that have been modernized, the background, and descriptions of the requirements for the conversion measures.

    • 12:50 - 13:35

    GMP Annex 1 and biological pharmaceuticals, challenges, and opportunities at the new pharma ecosystem.

  • Lyophilizing small batches, adjusted and flexible technological solutions.

    • 13:50 - 14:35

    Aseptic Lyophilization with the help of protective membrane bags to comply with EU GMP Annex 1

  • Annex 1 requirements for aseptic lyophilization processes
  • Sterile barrier function of the membrane to be used in Lyoprotect bags
  • Usage of pilot freeze-dryer without CIP/SIP to produce sterile medicinal products

    • 14:35 - 15:20

    Annex 1 and Containment: Lyophilization of Highly Potent Compounds

  • Annex 1 Requirements Loading and Unloading
  • Automation and Robotics
  • Requirements for the manufacturing of high potent sterile products
  • Cleaning requirements

    • 12:50 - 13:35

    Annex 1 and Lyocycle process control by applying the concept of Product Temperature of Critical Positions.

  • By determination of physical state of the Formulation for Lyophilisation and the according Critical Formulation Temperature a rational lyo cycle can be set up. Based on this, to define e.g. the end of primary drying (complete sublimation of ice), a real process control maybe applied. This will alter freeze drying, currently run by definition of time, Shelf Temperature and pressures of freezing, primary drying and secondary drying to a Product Temperature driven process.

    • 13:50 - 14:30

    Annex 1 Compliance with KÖGEL FILTER - LYOSAFE® Containment Concept for Freeze-Dried Bulk HPAPI Production

  • LYOSAFE® Containment System with an integrated particle free and sterile ePTFE- Membrane
  • Disposable Insulator for direct docking to the freeze dryer
  • Flexible and customized Harvest and Discharge System

    • 14:35 - 15:20

    Implementation of a Risk Assessment for Lyophilization Process and Sanitization

  • Providing a risk based approach to lyophilization process analysis
  • Risk based lyophilizer loading process
  • Establishing risk-based sanitization monitoring program • The role of risk management in lyophilization

    • Let’s Do it Hurry

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