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Aseptic Fill & Finish Excellence - Annex 1 Compliance and CFD Insights
Pharma & Biotech

Aseptic Fill & Finish Excellence - Annex 1 Compliance and CFD Insights

23 – 25 March 2026

Price available after dates are announced

TRAINING TIMES

  • 13:30 - 18:00Vienna
  • 12:30 - 17:00London
  • 08:30 - 13:00New York
  • 05:30 - 10:00Los Angeles
Online Training



LEARNING OBJECTIVES

Learning Objective

Keep

current and learn about new regulation changes e.g., EU GMP Annex 1 and the key points that impact biological product Fill & Finish and possible compliance gaps.

Learning Objective

Learn

about the full expectations of applying QRM and what a CCS is expected to cover in the process of defining the approach to sterile product manufacturing including organisational, technical and procedural control measures.

Learning Objective

Understand

the expectation of collective effectiveness with EM & PM with trend metrics that drive continuous improvement through the product life cycle.

Learning Objective

Learn

about the key challenges related to biological product filling including sensitivity to disinfection oxidising agents (VHP) and how to manage/control impact on products to meet regulatory and product quality requirements.

Learning Objective

Learn

about the technologies that are integrated into filling process platforms to meet the various critical quality attributes of biological products.

Learning Objective

Learn

about best practices in biological product aseptic manufacturing and regulatory observations in non-compliance.

Learning Objective

Learn

about the trends and future of biological product Fill & Finish.


WHO IS THIS TRAINING FOR?

Designed for professionals who want to enhance their expertise and advance their careers

Senior QA/QC

Regulatory Affairs

Materials Science and Technology (MSAT)

Production

Project Engineers and Technologists


KEY TOPICS

Impact on Fill & Finish of biological and ATMP products following Regulation revisions: EU GMP & PICS Annex 1, ICHQ9(R1) QRM and ICHQ12 Product life cycle management
Contamination Control Strategies (CCS) and the use of barrier and closed system technologies as principal contamination risk control measures. Considering the CCS as a Quality Maturity metric
Aseptic-Containment strategies and requirements for filing toxic and biologically active (hazardous) medical products, based on Health based exposure levels (ADIs PDEs) and managing cross contamination control
Bio-compatibility of biological products and gaseous disinfection residuals (vH202/VHP) – analytical chemistry studies and qualification methodologies
Risks assessments in contamination control and environmental monitoring – RA model characterisation for Aseptic processing – ICHQ9(R1) QRM compliant with reduced subjectivity
Protective Airflows including rules for ‘First Air’ protection with latest research using computational Fluid Dynamic modelling across critical process points of a Filing operation: Entry from Vial sterilising tunnel, Stopper loading to hopper-stopper feeder bowl including Glove interaction via opening RTP Port, Point of Filling including impact of filling needle holders
Airflow visualisation qualification via Smoke studies: best practices and experiences from Filling line Airflow visualisation qualifications for Annex 1 compliance
Scientific insights to automated VHP/vH202 bio-decontamination of Filling lines. Considering managing biological indicator quality variances including Rogue BIs and cycle validity checking straregies
Regulatory expectations on Assurance of Sterility of Direct and In-direct product contact parts in Filling; Bioburden control steps following parts sterilisation and best practice for installation on to the Filling line
Expectations in good cleanroom behaviour and good aseptic technique inside barrier technology respecting ‘First air principles’
Technologies in Aseptic process filling of biological products and their integration into filling platforms including: Single use Technology (SUT); Single use systems (SUS) and ready to use (RTU) pre-sterilised product containers/ closures, automation (Container transport/ filling/ closing systems/ robotics), Barrier technologies (Isolators and RABS), Lyophilizers (Freeze Dryers), IPC and CCIT technologies
Digitalisation of EM (Environmental monitoring) and PM (Process monitoring) data and trend analysis to set metrics that inform on state of control and need for improvements
Trends in aseptic manufacturing to support growth of more targeted medications and advanced therapies (smaller batches) plus applications of biologics in vaccines (large batches)

TRAINER

James L. Drinkwater

James L. Drinkwater

Franz Ziel GmbH, Head of GMP Compliance

James L. Drinkwater is the current Head of GMP Compliance at Franz Ziel Germany. James is based in the UK for the global role and separately supports the Not-for-profit society: Pharmaceutical and Healthcare Sciences Society: PHSS an educational platform in GxP. James is the ex-Chairman (10 years) of the PHSS and currently Co-leads the Annex 1 and CCS Guidance focus groups. James is also the leader of the PHSS Aseptic processing and Biocontamination special interest group that develops GMP guidance documents that are subjected to regulatory review before publication. James is also a member of ISPE and PQG (Pharmaceutical Quality Group UK). Current projects relative to this training span biological product filling lines, ATMP (Advanced Therapeutic Medicinal Products) combined formulation and filling platforms and associated sterility testing.

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