Annex 1 Conference - Current Requirements on Aseptic Manufacturing

Annex 1 Conference - Current Requirements on Aseptic Manufacturing

Berlin, Germany

Course No 16376


Costs

Non-ECA Members: EUR 1790,--
ECA Members: EUR 1590,--
EU GMP Inspectorates: EUR 895,--
APIC Members: EUR 1690,--

(All prices excl. VAT)

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org

Speakers

Jürgen Blattner, BSR, Germany
David Brückner, F. Hoffmann-La Roche, Switzerland
Friedrich Haefele, Boehringer Ingelheim, Germany
Andrew Hopkins, MHRA, United Kingdom
Daniel Müller, GMP Inspector, Federal State of Baden Württemberg, Germany
Arjan Langen, MSD, The Netherlands
Stephan Löw, CSL, Germany
Christiane Meissner, AGES, Austria
Franziska Petershagen, Vetter Pharma Fertigung, Germany
Tilmann Rock, Roche, Germany
Matthias Schaar, Novartis, Switzerland
Beate Reutter, GMP Inspectorate Federal State of Schleswig-Holstein, Germany

Objectives

This conference offers you the unique possibility to become acquainted with the new regulatory requirements of the Annex 1, the impact on aseptic manufacturing and the
challenges relating to quality aspects.

Authority speakers from different European Member States as well as representatives from pharmaceutical industry will provide you with information on their thinking about the new requirements. They will discuss the statements in the new Annex 1 with regard to topics like Quality Risk Management, Process Simulation/Media Fill and Container Closure Integrity Testing as well as the current expectations on premises, cleanroom qualification and the appropriate monitoring.

Additionally, the speakers will compare the requirements of the new Annex 1 with the expectations of other guidance documents like ISO 14644 or the relevant US guidelines.
Every topic will be covered by an authority and an industry representative to compare the regulatory with the manufacturers understanding.

Background

The Annex 1 “Manufacture of Sterile Medicinal Products” was published for the first time in 1971. During the following years it was updated several times, for example, to align the classification table of clean rooms, to include guidance on media simulations and bioburden monitoring in 2005 and 2007 or relating to capping of vials in 2010.
But for the first time, the currently published document represents a complete revision with the focus on providing a more structured guidance, including state of the art principles like Quality Risk Management and by paying attention to new technologies and innovative processes. It now includes new sections, as, for example, for utilities and enlarged topics like production and specific technologies or an increased guidance on the requirements of Aseptic Process Simulation (APS).

Target Group

This conference is of interest to professionals from pharmaceutical and biopharmaceutical manufacturers, authorities and suppliers with responsibilities in

  • Aseptic Manufacturing
  • Quality Assurance
  • Quality Control
  • Auditing
  • Inspections
who are involved in
  • Contamination Control
  • Monitoring
  • Qualification and Validation
  • Self Inspection
  • Quality Affairs
  • Process Simulation/Media Fill

Programme

Scheduled Presentations

Future sterile Manufacturing – an Authority Perspective

Modernisation and Implementation of Quality Risk Management (QRM)

QRM in sterile Manufacturing - Annex 1 and recent experiences

Annex1 – Authorities Expectation on Barrier Systems and Isolators

Industrial View: Impact on sterile Manufacturing of Biopharmaceuticals relating to Barrier Systems and Isolators

Authority Thinking on Qualification of sterile Facilities & Utilities - General Planning, Execution, Formalities

The New Utilities Chapter – Industrial Experiences

Qualification in Sterile Manufacturing: Annex 1 and ISO 14644 – a comparison

Container Closure Integrity – State oft he Art Testing in Context of Annex 1

FDA Guidance “Sterile Drug Products Produced by Aseptic Processing and the new Annex 1 – Accordance and Differences

Authorities Expectation on Contamination Control and Monitoring

Consequences on Microbiological Contamination Control and Environmental Monitoring - Expectations of Industry

Aseptic Process Simulations - Media Fill –current Challenges

Media Fill, just do it? – Practical Implementation

Automated Media Fill Inspection – State of the Art Testing and Modern Methods in Context of Annex 1

Sterilization & Sterile Filtration

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