Continued and On-Going Process Verification

Transcription

1 International Conference Continued and On-Going Process Verification Experiences with the New FDA and EU Guidelines on Process Validation Network with the Leading Companies in Pharma and Biotech on Topics Like Presenting Institutions and Companies EU Regulatory Expectations since Entry of the Revised EU GMP Annex 15 FDA s Culture of Quality and Quality Metrics on Process Validation Quality by Design: CPV in Practice APR/PQR in Re-Validation and Technology Transfer Risk Based Approaches to CPV Workshop QbD and Continued Process Verification Dr Jörg Gampfer, Baxalta AG, Austria Sponsored by Bernd Bödecker, GMP Inspectorate of Hannover, Germany Dr Ajaz S. Hussain, Insight, Advice & Solutions, LLC (Former FDA Deputy Director), USA Aidan Collins, Eli Lilly S.A. Irish Branch, Ireland Dr Kai Jürgens, Bayer Pharma AG, Germany M. Narendira Kumar, Orchid Healthcare (a division of Orchid Pharma Limited), India Adelheid Schweiger, Arcondis Group, Germany Antonio Mileo, Altergon Italia s.r.l., Italy Dr Frank Redeker, Pharmefficio Aachen UG, Germany Dr María Jesús Alonso Pérez, Reig Jofre Group, Spain Michael Paar, Mologen AG, Germany Paul Cleary, EirGen Pharma Ltd., Ireland Sabine Quast, Arcondis Group, Germany Gabriele Gold, Baxalta AG, Austria Ajay Pazhayattil, Apotex Inc., Canada 29 th February and 1 st March 2016 Conference 2 nd March 2016 Workshop Berlin, Germany presented by

2 Implementation of the New US FDA NfG on Process Validation and EU Annex 15 into Business Monday, 29 th February Registration and Coffee Networking and Lunch 8.50 Chairman s Opening Remarks Dr Kai Jürgens, GDD-GCPD Clinical Supply Operations Solids, Bayer Pharma AG, Germany 9.00 On-going Process Verification EU Regulatory Expectations since the Entry of the Revised EU GMP Annex 15 into Force Contents of EMA Note for Guidance on Process Validation and of Annex 15 with respect to On-going Process Verification (OPV) OPV in EU GMP inspections Traditional and enhanced approach to Process Validation implications for OPV Relationship between OPV and Product Quality Review (PQR) Bernd Bödecker, EU GMP-Inspector, Trade & Industry Inspection Agency of Lower Saxony/Hannover Office, Germany 9.50 FDA s Trending New Validation Strategies FDA s push for Culture of Quality and Quality Metrics Why and how can these address current challenges? What are the key connectors between Culture Metrics Stage 3 CPV of Process Validation? How can CPV be implemented in a way that it simultaneously addresses the regulatory expectations in EU and the US? Dr Ajaz S. Hussain, Insight, Advice & Solutions, LLC (Former FDA Deputy Director), USA Q&A Session with Speakers Networking and Coffee Implementation of Statistical Process Control in Pharmaceutical Industry How can Statistical Process Control (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 Antonio Mileo, Patch Production Manager, Altergon Italia s.r.l., Italy Managing Stage I Data from a Development Point of View Challenges in establishing CPV plans in early development phases Validation strategy and schedule what do inspectors expect and accept? Definition of critical process parameters DoE, PAT and risk based approaches: buzzwords in daily practice Dr Kai Jürgens, GDD-GCPD Clinical Supply Operations Solids, Bayer Pharma AG, Germany Q&A Session with Speakers Networking and Coffee CPV in Practice a Quality by Design Point of View Development of a risk based control strategy Creation of appropriate listening systems Measuring of product and process performance Continuous evaluation of control strategy and feedback loops/revalidation Gabriele Gold, Head of PSTO/QbD, Baxalta AG, Austria A Risk Based Approach to CPV Process Validation in the context of a product s lifecycle management Steps to take after validation of the manufacturing process Review of traditional approaches to Process Validation and possible paths to CPV implementation for biotechnology process Change management: the key to maintaining the validated state from handling minor change to process scale up Aidan Collins, Scientist, Technical Services Manufacturing Sciences, Eli Lilly S.A. Irish Branch, Ireland 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 Change and Risk Management in Continuous Process Validation Process Validation in life cycle management Traditional vs. enhanced approach From scaling-up to change management Adelheid Schweiger, Senior Consultant Quality & Compliance, and Sabine Quast, Senior Consultant Quality & Compliance, Arcondis Group, Germany

3 Implementation of the New US FDA NfG on Process Validation and EU Annex 15 into Business Tuesday, 1 st March Chairman s Opening Remarks Dr Kai Jürgens, GDD-GCPD Clinical Supply Operations Solids, Bayer Pharma AG, Germany 8.30 A Business Case For Stage 3: Continued/Ongoing Process Verification Knowledge management: OPV data for new product, process development Knowledge management: OPV data for investigations, APQR (QA) Cost of Quality: relevance of real time OPV (operations) Stage 3A: A new tool for Process Robustness Stage 3B: signal detection, notification, statistical assessment and action upon yellow flag Addressing QbD, PV, Quality Matrix regulatory requirements, ICH Q12 How to achieve the desired results overcoming challenges? Return of investment justified Ajay Pazhayattil, Associate Director, Technical Operation-Process Validation, Apotex Inc., Canada 9.20 Challenges in Change Management and Change Control Regulatory requirements and guidelines Deviation or change? Options for the organisation of an efficient change control Michael Paar, Director Quality Control/Qualified Person, Mologen AG, Germany Networking and Lunch CPV with Relation to the Contract Manufacturing Organisation Audit and control by customers Inspection by regulatory bodies Leveraging on early stage characterisation work Importance of optimisation work APR/PQR review Validation Master Plan Change management Paul Cleary, Head of Quality & Qualified Person, EirGen Pharma Ltd., Ireland Process Validation Review During Regulatory Inspections Regulatory expectations on process validation Observations reported during various regulatory inspections Audit readiness with respect to Process Validation M. Narendira Kumar, Head Quality Assurance (Formulations), Orchid Healthcare (a division of Orchid Pharma Limited), India Q&A Session with Speakers Closing Remarks Q&A Session with Speakers End of Conference Networking and Coffee Conference Element: Visualisation of Content APR/PQR in Re-Validation and Technology Transfer Implementing CPV into Business Integration of APR/PQR into the life cycle model Data Analysis and Review Pharmaceutical Quality Matrix Capability Analysis Legacy products: - from traditional to continuous process approach - hybrid approach Justification of number of PPQ batches Creation of appropriate listening systems for developing of unwanted and unintended process changes Maria Jesús Alonso Pérez, Director Quality Assurance, Reig Jofre Group, Spain (Graphic Recording of Conference Qualified Person Strategies for Successfull Process Validation according to Annex 15 Process Validation for the product registration PQR and continuous Process Verification Process Validation during the product lifecycle Dr Frank Redeker, Managing Partner, Pharmefficio Aachen UG, Germany Contact Details for Enquiries: Anne Meyer Senior Project Manager anne.meyer@chem-academy.com

4 Workshop Wednesday, 2 nd March Reception and Coffee 9.00 to QbD and Continued Process Verification (breaks will be arranged flexibly) YOUR COURSE FACILITATOR Dr Jörg Gampfer, Head of Commercial Manufacturability & Platforms, Baxalta AG, Austria Dr Gampfer has more than 15 years of experience in the pharmaceutical industry ranging from early exploratory research to process development and commercialisation. His main focus in the recent years was to establish a QbD programme for Baxter Bioscience covering all three stages of Process Validation, reaching from Process Design and Manufacturability to Continued Process Verification. He obtained a degree in chemistry at the University of Würzburg (Germany) and a PhD in the field of Molecular Biology/Immunology at the University of Natural Resources and Life Sciences, Vienna (Austria). After holding a senior scientist position in vaccine development, he joined Baxter in 2005, heading a department for Product & Process Design. In 2011 he accepted a Six Sigma Master Black Belt position supporting process development and commercial manufacturing sites for plasma fractionation and recombinant production. He is now heading the Baxalta department for Commercial Manufacturability & Platforms combining sound science, risk and knowledge management to effectively govern efforts and strategy for development and process maintenance across the product life cycle. Content of Workshop Exploring the Regulatory Landscape Annex 15 with respect to On-going Process Verification (OPV) FDA s Stage 3 CPV of Process Validation Combining the regulatory expectations of the EU and the US Is Continued Process Verification an additional burden or rather a chance for efficient continuous improvement and increased operational efficiency? This interactive workshop establishes an approach to CPV for a model process. It evaluates obstacles and opportunities and leads participants to draft a sample solution for their individual requirements. The introductory part summarises key parts of the regulatory landscape to provide a common understanding and scene setting of the workshop. It also serves as a bridge to the next part: why building process knowledge is essential for CPV. 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? Having covered the relevant regulatory requirements the course focuses on the more concrete challenges. Upcoming activities are summarised and prioritised in order to shape a project, involving a number of departments. Delegates will have to work out the key aspects of their projects and keep in mind the purposes of their control strategy. Furthermore, this part looks into the signals regarding Process Performance Qualification and how to differentiate between essential and negligible signals. Reaction Mechanisms and Criticality of Organisational Structures Influencing factors and impacts Defining and adjusting organisational structures to CPV-needs Maintaining compliance is one of the vital aims of the project management outlined above. This part of the workshop addresses the measures to be taken for certain influencing factors regarding organisational structures and reaction mechanisms. How can the responsible staff aggregate sufficient information to define and adjust processes to their needs? Which methodologies for risk assessment are available? 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 Continued Process Verification has become more and more important for a growing number of companies. The workload will increase for most of the stakeholders from industry and authorities. The final part of this workshop will deal with the bottlenecks that are most likely to occur and how to find ways out of this maze. Advance Notice 3 rd Annual Conference Qualified Person 25 th to 27 th April 2016 Bonn, Germany (Conference Language: German) 3 th Annual Conference Pharma IT Compliance 13 th to 15 th June 2016 Bonn, Germany (Conference Language: German)

5 About us About Chem-Academy Chem-Academy is a division of Vereon AG and is running both industry specific conferences and courses since Its main target groups are the chemical and the pharmaceutical industry. Events mainly focus on regulatory topics, e.g. chemical regulation like REACH or the GMP framework for pharmaceutical companies. Representatives of all major companies as well as of the most important public authorities give presentations or facilitate courses. Impressions Q&A Sessions Graphic Recording Evening Reception Case Studies Networking Sponsor ARCONDIS is the largest consulting company exclusively specialized in the life sciences industry in the DACH region (German speaking countries). We have been managing challenges and projects for our customers in the areas of compliance, information management and IT management since In so doing, we create added value through cross-functional, sophisticated concepts and intelligent implementation under consideration of regulatory aspects. Our many years of experience in regional and international projects in the field of life sciences and our methodicalpragmatic approach build the foundation for our exceptionally multifaceted services. With interdisciplinary teams and project experience in 2,500 orders for over 135 corporations and small to medium businesses, we have a unique mix of competencies. We believe that people make the difference, and we give our employees a strong foundation upon which to jointly achieve success with our customers in a very challenging environment. Media Partners European Pharmaceutical Review is the leading bi-monthly technical journal for the pharmaceutical industry, and essential reading for anyone involved in drug discovery or manufacturing. It will keep you up to date with new developments and projects within the dynamic European pharmaceutical environment, featuring articles on topics that impact the sector, including: cellular imaging, drug discovery, microbiology, stem cells and toxicology. At European Pharmaceutical Review we pride ourselves on our editorial integrity. We attract the leading industry experts to write on subjects that readers need to know about. The strength of European Pharmaceutical Review is reflected by our circulation figures, with an estimated 30,000 readers across the globe. PharmaVOICE magazine provides readers with insightful and thought-provoking commentary about the challenges and trends impacting the life-sciences industry in a multiple-perspective format through articles covering a range of issues from molecule through market. PharmaVOICE s more than 41,000 BPA-qualified subscribers are also kept abreast of the latest trends and information through additional media resources, including WebLinx Interactive WebSeminars, Podcasts, Videocasts, White Papers, E-Surveys and e-alerts. Founded in 2000, Technology Networks is established as the leading news provider for life science and drug discovery professionals. In addition, we provide unique content including webcasts, videos, application notes and posters from recent conferences. Our portfolio now includes around 30 focussed scientific communities, all of which are accessible free of charge within TechnologyNetworks.com.

6 Register now on Contact us Web chem-academy.com Fax Mail Vereon AG Chem-Academy Postfach Kreuzlingen 1, Switzerland Conference Venue Web Telefon Anschrift Novotel Berlin am Tiergarten Straße des 17. Juni Berlin, Germany Terms and Conditions Conference: Continued and On-Going Process Verification I would like to register: Conference and Workshop* 29 th Feb to 2 nd March 2016 Conference 29 th Feb to 1 st March 2016 Workshop* 2 nd March Contact Details Title First Name Second Name Position Department Organisation Phone Street or P.O. Box Postal Code City Country Billing Address 2,395 EUR (plus VAT) 1,995 EUR (plus VAT) 1,595 EUR (plus VAT) Unfortunately, I am not able to participate at the conference. Please send me more information via . Order Reference VAT Number Company Department 1. Registration Registration is confirmed in writing by the organisers. The registration fee covers attendance at the lectures for the number of days selected, full documentation, entrance to the exhibition area, lunch and refreshments. VAT has to be added. Important note in terms of late payment: As mentioned in the registration form all payments must be received within the due date given in the invoice. If you assume that your company is not able to manage payment in-time by bank transfer, please provide your credit card details in order to guarantee your booking. This helps to avoid any inconvenience upon your arrival at the event. At that time the full amount of the payment must be received in our accounts at latest. Thank you very much for your co-operation. 2. Cancellations Cancellations of a registration by a delegate has to be received in writing at least 30 days prior to the event and will be subject to a service charge of 200 Euro. Substitutions are acceptable at any time. Where cancellations are received later, the registration fee remains payable in its entirety. In case the event has to be cancelled by the organiser payments already received will be credited for the following year's event. 3. Liability It may be necessary for reasons beyond the control of the organiser to alter the content or the timing of the programme or to cancel the event. The organiser of the event is not liable to pay any compensation or damages resulting from alteration, cancellation or postponement of the event. The organiser will do the upmost to inform the delegates of such modifications as early as possible, but is especially not liable if higher force or unforeseen incidences are affecting the meaningful implementation of the event. Force majeure includes: armed conflicts, civil strife, terrorist threats, natural disasters, political constraints, significant influence of transport, etc. 4. Data Protection The organiser gathers and processes data in accordance with data protection laws. Your data is stored electronically for the purpose of future updates of our services. If you wish your data to be amended, removed or not passed to an external organisation, please write to info@chem-academy.com. 5. Final Clauses The contract is subject to the Swiss law. Area of jurisdiction is Kreuzlingen (Switzerland). Address Postcode, City Date, Signature I would like to pay by credit card. Please send me the payment information via . *limited number of seats