GMP/FDA Compliance Conference

Objective

Reasons to attend this conference: You will receive an overview of current regulatory developments in the area of pharmaceutical production with a focus on:

  • EU GMP Guide Annex 1 revision
  • Data integrity
  • USP trends
  • Risk management

Background

Even during the pandemic, the further development of GMP does not stand still. GMP requirements from regulatory guidelines have an influence on pharmaceutical engineering and pharmaceutical technologies. Examples from pharmaceutical practice show possibilities for implementation. In addition, it will be discussed how GMP compliance can be maintained in times of the pandemic.

Target Audience

The event is directed at specialists from the pharmaceutical industry as well as at engineers and planners who have to deal with current aseptic technologies in clean areas in their daily practice. It particularly addresses the departments:

  • Production
  • Quality assurance
  • Engineering / Technology

Moderator

Jörg Zimmermann, Vetter Pharma-Fertigung
Gert Moelgaard, Moelgaard Consulting

Programme Download

Please click on the programme image to download the programme as PDF.

Registration

To register for the conference, please see the registration options.

Detailed Programme

Presentations - 31 May 2022

Experience from COVID-19-Pandemic- a GMDP-Inspector’s View
Dr. Daniel Müller, Local GMP Authority of Baden Württemberg

  • Challenges & options for GMDP-surveillance
  • GMDP-Inspections
  • Marketing authorisation licensing agencies
  • On-site inspections, distant assessments or hybrid approach
  • Experience during last 2 years of pandemic situation

GMP Compliance Trends during COVID-19 Outbreak
Balasubramanian Ramaiah, Accord Healthcare

  • Does Covid-19 GMP flexibilities compromises the compliance?
  • How the NCA monitor the GxP compliance?
  • NCA road maps to GMP inspection reliance
  • Reliance of remote vs physical inspections
  • Inspection finding trends during Covid-19 outbreak

From Risk Analyses to Traceability Matrix 4.0
Christoph Holzmann, MSD AH Danube Biotech
Dr. Brigitte Gübitz, VTU Engineering

  • Integrated commissioning and qualification – requirements and regulations
  • FMEA - the centerpiece of a successful iC&Q approach
  • Traceability right from the beginning - integration of user requirements into risks assessments
  • Leveraging approach – how to link mitigating actions with commissioning procedures and qualification tests
  • Automated risk assessments to create C&Q documents electronically
  • Hot to use a life-cycle FMEA to track changes during a C&Q project

The ECA Good Practice Guide for Suppliers and Users on integrated Qualification and Validation
Gert Moelgaard, Moelgaard Consulting

  • Introduction to the guide
  • The role of a good supplier partner for effective qualification projects
  • Equipment categories as tool for qualification planning
  • Remote testing with web based computer tools
  • Case stories from successful qualification projects

Update on USP’s Bioreactivity, Extractables and Glass Containers Packaging
Dr. Michael Eakins, Eakins & Associates

  • Bioreactivity
    • Deletion of outdated methods in <87> and <88> and addition of genotoxicity methods to <87>
    • Deletion of the plastic classification system of Classes in <88>
    • Moving sensitization methods from <1184> to <88>
    • Expand the scope of <1031> to encompass plastic materials of construction for pharmaceutical packaging/delivery systems
    • Add a risk-based approach to biocompatibility evaluation in <1031>
  • Extractables & Leachables
    • Revise and update <1663> and <1664> in line with current thinking
  • Glass Containers
    • Incorporate new materials of construction
    • Update key quality tests
    • Revise spectral transmission test

Review of Online Water Monitoring Analyzers (OWBA) and their potential Application
Dr. Hans-Joachim Anders, Novartis Pharma Stein

  • Available methods and their measurement principles
  • Possible applications of OWBA for quality control
  • Evaluation study results for Aqu@Sense
  • Speedbumps regarding implementation of OWBA

Ensuring Data Integrity in the daily Practice of Pharmaceutical Manufacturing
Dr. Philip Hörsch, Vetter Pharma-Fertigung

  • Handling of recipes and settings in manufacturing
  • Role of in-process-controls
  • Definition of quality-/decision-relevant data
  • Examples of manufacturing processes and their data and audit trail review procedures
  • Paper-/electronic hybrid situations and their impact on data review and audit trail review procedures
Presentations - 1 June 2022

Update EU GMP Annex 1
Dr. Daniel Müller, Local GMP Authority of Baden Württemberg

  • Update on Annex 1-Revision process
  • Comparison old- & new version
  • Important changes, serious improvements
  • Points of discussion

Compliance trends and their Impact on Technological Developments (in sterile Manufacture)
Jörg Zimmermann, Vetter Pharma-Fertigung

  • Panelists included Rick Friedman, Brooke Higgins, Robert Sausville, Alonza Cruse, Thomas Arista and more
  • FDA thinking on Annex 1
  • Learnings from remote assessments and data requests
  • Auditing in times of COVID
  • Regulations for ATMPs and their interpreation

Airflow Visualization / Aseptic Process Simulation
Luigi Scaffidi, Boehringer Ingelheim Pharma
Christian Gavranovic, PPT Pharma Process Technology

  • Airflow Visualization
  • Guideline
  • Life Cycle / Technique
  • Link to APS
  • Aseptic Process Simulation

Sterile Filtration – How to Keep Flexibility and Regulatory Compliance
Simone Biel, Merck

  • Filter inside or outside the isolator?
  • Redundant filtration – the extra piece of mind?
  • PUPSIT required – but exceptions allowed?
  • Post-approval change of a filter – critical or non-critical?
  • Multiple use of a filter?
    Filter as part of a ready to use single-use system – how to ensure integrity downstream the filter?

Quality Assurance for Contrast Media – Parametric Release & New Annex 1
Dr. Stephan Heck, Bipso

  • Overview of contrast media and mechanisms of action (for X-ray examinations and MRI)
  • Quality requirements for sterile production: terminal sterilized vs. aseptic production
  • Parametric Release – Possibility to increase quality and productivity in sterile production
  • New Annex 1 – Contamination Control Strategy

CCS (Contamination Control Strategy): Is it really a new Tool ?
Jean Denis Mallet, ECA

  • Introducing the concept of Contamination Control Strategy" as a powerful tool to ensure the quality (sterility), safety (sterility) and efficacy of product
  • A list of different components that form the CCS and analyse the link / relation ship from one to another
  • In this aspect it can be accepted that CCS is 'simply' a structuration of what the more performing companies already do

How to implement a CCS according to Annex 1 (“A Guide to the Guide”)
Robert G. Schwarz, GXP-TrainCon e.U.

  • ECA’s Guide on “How to Develop and Document a Contamination Control Strategy”
  • Implementation from the scratch (for newbies in GMP)
  • Putting together the pieces (for the ambitious advanced in GMP)
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