Continued and On-Going Process Verification

20th and 21st March 2017 - Conference
22nd March 2017 - Workshop
Novotel Hamburg, Germany

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Intro / Registration  / Agenda / Speakers / Media Partners / Venue

Monday, 20th March 2017

Registration and Coffee

Chairman’s Opening Remarks
Dr Kai Juergens, Senior Project Manager External Manufacturing, Bayer Pharma AG, Germany

GMP Expectations After the Implementation of Annex 15
• Requirements of Annex 15
• The status of the EMA guide on process validation in GMP environment
• Status of implementation from an inspector´s view
Klaus Eichmueller, Wolnzach c/o Regional Council Darmstadt, GMP Inspectorate, Germany

FDA’s Trending New Validation Strategies
• Contents of FDA’s Guidance to process validation
• How can a global harmonisation be achieved?
• Options for implementation into practice
Dr Ajaz S. Hussain, Insight, Advice & Solutions, LLC, former FDA Deputy Director, USA

Networking and Coffee Break

Integration of the CPV Programme into a Global Organisation
• Defining elements of CPV Stage 3A
• Which criteria and indices have to be considered?
• How should manufacturers react to CPV Stage 3A, 3B statistics signals?
• How to use a risk based approach
Ajay Pazhayattil, Associate Director, TO Process Validation, Apotex Inc., Canada

CPV Deployment Strategy
• Challenges in determining which principles are needed to validate the platform at UCB
• Review of the UCB organisation for CPV strategy deployment
• Definition on how UCB’s CPV guidances can be translated for use in a data platform
• Review on how to use processing systems for data capture, database integration, creation of hierarchies, data visualisation and information sharing
Nicolas Ballois, Process Data Specialist, UCB BioPharma sprl, Belgium

Networking and Lunch

Continued Process Verification from a Contract Manufacturer’s Point of View
• Working out a CPV plan by integrating customer requirements
• How to deal with various requirements from a broad range of customers
• Business Process Optimisation from a contract manufacturer’s perspective
• Challenges with reporting
• Specific challenges with new products vs. legacy products
Dr Philip Hoersch, Director QA - Validation/Risk Management/Trending, Vetter Pharma-Fertigung GmbH & Co. KG, Germany

CPV Challenges with Outsourcing
• Risks and benefits of outsourcing with regard to CPV
• The manufacturer’s policy as framework
• Definition of critical process paramaters
• How to deal with legacy products
• Challenges with the handover to external manufacturing partners
Dr Kai Juergens, Senior Project Manager External Manufacturing, Bayer Pharma AG, Germany

Networking and Coffee Break

CPV in Practice – a Quality by Design Point of View
• Development of a risk based control strategy
• Measuring of product and process performance
• Continuous evaluation of control strategy and feedback loops/revalidation
• CPV and Validation Maintenance
• CPV reporting - Dashboards
• CPV in CMO collaborations
Gabriele Gold, Head of Quality by Design, Process Development & Technical Services, Shire, Austria

SPC as Part of Continuous Validation
• How can SPC be used in practice?
• SPC as proof of continuous validation
• Process development, re-evaluation und definition of parameters
• Challenges regarding the process performance validation approach
Dr Per Vase, Managing Partner, Applied Manufacturing Science, NNE Pharmaplan, Denmark

Closing Remarks

Evening Reception
Following the official part of the conference, Chem-Academy invites you to a social evening reception at an atmospheric local restaurant. Benefit from the informal surrounding to intensify business contacts and extend your network.


Tuesday, 21st March 2017

Chairman’s Opening Remarks
Dr Kai Juergens, Senior Project Manager External Manufacturing, Bayer Pharma AG, Germany

Process Validation Review During Regulatory Inspections
• Process validation definition and regulatory expectations
• General considerations on process validation throughout the lifecycle
• How to approach CPV
• Observations reported during various regulatory inspections
• Maintaining audit readiness with respect to Process Validation
M. Narendira Kumar, Associate Director & Head Quality Assurance, Dr. Reddy’s Laboratories, India

Usage of Quality of Design in Formulation and Process Development
• Application in product and process development
• Quality by Testing vs Quality by Design
• Effective process monitoring – Identification of relationship between causes and effects
• The framework – Quality by Design and product lifecycle
Stavros Politis PhD, Director Formulation Development, Genepharm S.A., Greece

Networking and Coffee Break

Responses to Signals from a Continued Process Verification System in the Biopharmaceutical Industry
• Defining parameters and attributes and their signal criteria
• Signal evaluation and actions
• Signal review and escalation process
• Example Outcomes of Cross Functional Team Reviews
• Required documentation
Richard Falcon, Senior Process Scientist, Pfizer Biotech Ireland

Tools to support CPV implementation
• Presentation of “tools” to implement CPV
• Data capture with a data warehouse solution
• Continuous monitoring through a SPC interface
• Reporting on sharepoint
Baptiste Berruée, Responsable plateforme MPCS, Sanofi Pasteur – MTECH, France

Networking and Lunch

New approach to API process validation in light of ICH Q7-Q11
• Process validation in the context throughout the lifecycle of an API
• Review of traditional vs. new approaches to process validation for API’s into practise
• Risk based approach to process development/design
• Moving from a traditional approach to process validation to targeting CPV
Jarle André Haugan PhD, Primary Production Oslo Plant, GE Healthcare Life Sciences, Norway

Process Validation and Statistical Trending in Pharmaceutical Manufacturing
• CPV as part of PQR efforts
• Statistics and validation: Who is in charge of what?
• Tracking and trending of processes and the statistical analysis of the respective data
• Challenges with generating data vs. challenges with evaluating data (time/efforts needed,
   automatic vs. manual data capture)
• Definition of useful parameters for different types of computerised systems
• Special topics: tracking and trending of dissolution data, handling of low volume products,
   data storage
• Validation status assessment: from process capability to confirming the state of control
• Local measures within a global QA organisation
Dr Anja Keubler, Head of Process Validation and Business Intelligence, AbbVie Deutschland GmbH & Co. KG, Germany

Networking and Coffee Break

Continued Process Verification of Legacy Products in the Biopharmaceutical Industry
• The complexity of implementing CPV for legacy products
• Means to reduce the number of unexpected process upsets, emergency investigations,
   and product quality variability
• Key elements for more efficient identification, justification and implementation of process
• Data management: coping with regulatory approval requirements for process changes
• How to achieve more consistent methods for manufacturing monitoring and process control
Robin Payne, Facilitator, BioPhorum, United Kingdom

Closing Remarks

End of Conference


Wednesday, 22nd March 2017

Continuous Process Verification: Design, Structure, Continuous Improvement
Robin Payne, BioPhorum, United Kingdom
Dr Joerg Gampfer, Hovione, Portugal

Reception and Coffee

9.00 to 15.30
(breaks will be arranged flexibly)

Content of Workshop

The Regulatory Framework and Key Challenges for the Industry
• Combining the regulatory expectations from the FDA and European authorities
• Annex 15 with respect to On-going Process Verification (OPV)
• FDA’s Stage 3 CPV of Process Validation
• Evolving requirements such as Quality Metrics
• Open questions – future opportunities

Building Process Knowledge – Fact and Risk Based Process Design
• Establish a process “Control Strategy”
• Process Performance Qualification – what do we learn and what signals should we continue
   to listen to?
• The role of maintenance efforts: Keeping the “State of Control”

Making It Work: The Role of Organisational Structures, Interactions and Communication
• Communication is key: What factors have critical impact?
• Understanding and adjusting operational mechanisms and organisational structures
   to CPV-needs
• Tripartite interaction between contract manufacturer, customer and regulators

The Evolution of a CPV Programme and Opportunities for Continuous Improvement
• Challenges yet to face – bottlenecks to be expected when working with CPV
• Open questions – future opportunities