Facilities Design, Upgrade and Expansion

Day One - Monday, 28 April 2008
09.30	Opening remarks
09.40	GMP for facilities from design through to operation The Link Between Quality Products and the Quality of the Manufacturing Facilities How Critical Quality Attributes of the Product (ICH Q8) are Used to Design an Efficient Facility. Risk-Based Approach to Validation for Facilities (ICH Q9/Q10) Aligning Design, Commissioning, Qualification, Validation, and Operation Efforts to Maximise Product Safety. Examples of how GMP Does Not Commence at Validation, but Should be Incorporated from the Initial Stages of Design Nick Kotlarski, Principal Consultant, Synertec Asia Pte Ltd
10.20	Biotech Facility Renovation and Expansion Key Considerations for Design of Biotech Facilities Unit Operations in Biotech Production Air Classifications, Material and Personnel Flows Determining Project Drivers, Objectives and Scope Establishment of an Integrated Project Management Team Key Design Issues to Consider for Renovation Project Challenges in Maintaining Operations During Facility Renovation/Expansion Michael Chan, Sr. Vice President/CFO, PQC Consulting, Inc.
11.00	Break
11.20	Innovative Design and Fast Track Execution  The Modular Concept-A Flexible Technology  Fast track design/building plan   Turn-Key Project Delivery  Commissioning Capabilities  Client Project Objectives Batch Division of Design and Fabrication  Jan Lilja, Director of Business Development, Pharmadule
12.00	Technological Solutions for Your Cleaning Validation Challenges Regulatory requirements for CV Importance of documentation Residue limits & sampling methods Preparing samples for TOC analysis Didier Morand, Eastern European Sales Manager, GE Analytical Instruments
12.40	Lunch break
14.00	Functional Planning of Modern Facilities for Flexibility and Future Expansion Case Study: Expansion of Biotech API Production Capacity Structured, functional and modern GMP Facility Design Designing Flexibility and Adaptability into your Facility Facility Organization Dirk Steinhaeuser, Head of Business Development Biotechnology Plants, Linde-KCA
14.40	The Integration of the Design Team for High Tech Building Design The importance in consulting a specialized a Technological Engineer Good planning and bad planning: Opportunities and challenges Identifying the Roles of the Design Team  Case Studies to Demonstrate and Evaluate the Integration of the Design Team Prof. Firas Al-Hinnawi, Biomedical Engineering Department, FMEE, University Of Damascus
15.20	Break
15.40	Process Validation-Basics to Benchmarking  Principles and Expectation  Fundamental Approaches for Various Types of Process Validation Scientific and Technical Principles Process Validation Performance Maintenance of the Validated State Problems and Pitfalls Paul Pluta PhD, Director Quality/Techical, Chicago Control Systems Inc.
16.20	GMP Component for Innovative Design Designing to meet Process Requirements Facility Space and Utility Requirements Advances in cGMP Technology  Elimination of Dead Legs or Dead Zones to Reduce the Risk of Cross Contamination or Cool Spots  Maximizing Drug Product Quality Technology Evaluation for Performance and Validation  Alain Rachon, Technology Manager for Biopharmaceutical Market, Millipore SAS
17.00	Close
Day Two - Tuesday, 29 April 2008
09.30	Systematic Design of Biotech Plants: From Concept to Complete Plants GMP / GEP Planning Approach to Facility Design Design Principles: Functional, GMP, Technical and Aesthetic Project Phases and Key Success Factors Coordination and Space Management Modern Engineering Tools Dirk Steinhaeuser, Head of Business Development Biotechnology Plants, Linde-KCA
10.10	Producing, Storing and Handling Heat Sensitive Products in the Middle East  Temperature profile of UAE and GCC throughout the year. Thermodynamics and Heat Denaturation of protein, glycoprotein and other biological molecules. Genomics and proteomics of Thermostable proteins and Glyco-proteins. Biological formulations and stability study results. Understanding Water Activity and effect on unfolding of protein and conformational changes. Lab assay methods to test protein stability. Accelerated stability and Experiment design. How to increase stability of proteins and bio-molecules by using approved ingredients. Tips on designing, processing, storage and handling of heat sensitive products, a UAE Biotech company perspective. Debayan Ghosh, President, Epygen Biotech
10.50	Break
11.10	How to Increase Process Sterility Assurance Level Using Disposable Technologies  Aseptic processing Validation Master Plans for introducing Novel Technologies  Comparison of Existing Master Plans for Traditional Technologies Regulatory Requirements and Validation Practices for Extractables and Gamma Radiation Sterilization of Plastic Product Components Emergency Management Alain Rachon, Technology Manager for Biopharmaceutical Market, Millipore SAS
11.50	Ensuring Market Competence Through Implementing Quality Assurance Systems in Training- Experiences in Implementing  ISO 10015 Implementing ISO 10015 Quality Management Principles Human Resource Management Governance Models M. Ganesan, Managing Director, Micro Therapeutic Labs Pvt. Ltd.
12.30	Lunch
14.00	Laboratory Informatics-a Key Element of Facilities Design within the Pharmaceutical and Biotechnology Manufacturing Industry  Software Systems  Managing the Manufacturing and QA/QC Process LIMS as an Element of any Integrated Manufacturing Systems  Integration of LIMS with other Software Systems  How LIMS Can Support Regulatory Requirements Management of Data, Certificates of Analysis, Standard Operating Procedures and Product Specifications Dr. Simon Wood, Executive Director of Marketing and Education, STARLIMS Corporation
14.40	Science Parks Introduction to Science Parks Building Philosophy Site Philosophy Site Facilities Design Forward Look Brian Kowalchuk, Director of Design, CUH2A
15.20	Break
15.40	Sustainability the Challenge  Energy Efficiency and conservation Materials Location and Environmental Impact Innovative green concepts Bill Jolly, Hyder Consulting
16.20	Trends in Biopharmaceutical Manufacturing Pressure on pipeline efficiency and cost of treatment Focus on manufacturing efficiency and costs Switch from dedicated to multiproduct facilities Widely varying API categories and production sources Widely varying production scales, few kilograms to multiton Flexibility, agility, cost efficiency Günter Jagschies, PhD, Senior Director R&D, Strategic Customer relations GE Healthcare Bio-Sciences AB Uppsala, Sweden
17.00	Close
Invited Faculty
Dirk Steinhaeuser, Head of Business Development Biotechnology Plants, Linde-KCA Paul Pluta PhD, Director Quality/Techical, Chicago Control Systems Inc. Chris Taylor, Director, Faithful + Gould Jan Lilja, Director of Business Development, Pharmadule Alain Rachon, Technology Manager for Biopharmaceutical Market, Millipore SAS Nick Kotlarski, Principal Consultant, Synertec Asia Pte Ltd Prof. Firas Al-Hinnawi, Biomedical Engineering Department, FMEE, University Of Damascus Didier Morand, Eastern European Sales Manager, GE Analytical Instruments Dr. Simon Wood, Executive Director of Marketing and Education, STARLIMS Corporation Debayan Ghosh, President, Epygen Biotech Brian Kowalchuk, Director of Design, CUH2A Bill Jolly, Hyder Consulting Michael Chan, Sr. Vice President/CFO, PQC Consulting, Inc. M. Ganesan, Managing Director, Micro Therapeutic Labs Pvt. Ltd. Günter Jagschies, PhD, Senior Director R&D, Strategic Customer relations GE Healthcare Bio-Sciences AB Uppsala, Sweden
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