| Tuesday, 29 May |
| Concurrent Breakout Sessions |
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C&Q / VALIDATION |
INNOVATIVE COST REDUCTION TECHNOLOGIES/ HOT TOPICS |
| 0930-1300hrs |
“Comparison of new ISPE Good Practice Guides (Science and Risk-based approach for the delivery of facilities systems and equipment, and Applied Risk Mangement for Commissioning and Qualification) with ASTM E2500:07 and other Industry Standards"
Beginning in 2001, ISPE has issued several baseline guides and good practice guides related to commissioning and qualification, and ASTM has issued its E2500 "Standard Guide to Design, Speification, and Verification of Pharmaceutical and Biopharmaceutical manufacturing facilities." The first ISPE Baseline Guide, Volume 5, provided for impact assessments and various qualification practices, designed to separate critical from non-critical systems and provide rules of the road for how to conduct qualification. With ASTM E2500, ISPE has developed two good practice guides to help teams implement ASTM, either in full or as a hybrid with the old volume 5 approaches. This presentation will compare and contrast the different approaches, frame the approaches within recent regulatory trends, and also discuss the practical considerations necessary to achieve a successful project delivery.
Mr. Robert Chew, President & CEO, Commissioning Agents, Inc., USA |
“Impact of EFP Technology in the Pharmaceutical Industries”
This talk will focus on the impact of EFP Technology in the pharmaceutical industry, with special attention on waste treatment costs. EFP is a totally green technological solution with no secondary by products evolution and is highly energy efficient with low treatment cost. Likewise, maintenance and service cost of EFP Technology is low due to its design virtues and simple operational procedures and is a non-chemical process. This technology can assist the pharmaceutical industry in the lowering of its production costs.
Dr. Simon Koh, Chief Executive, Enviroclean Technology and Engineering Pte. Ltd., Singapore |
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“Facility Design and Technology Transfer Strategy for Flexible Multiproduct Large-scale Contract Biologics Manufacturing"
Manufacturing flexibility and rapid technology transfer are critical to the success of a contract manufacturing facility. Lonza Biologics newly constructed and commissioned facility in Singapore houses a range of fermenter capacities (200L to 20000L) and the necessary downstream purification suites to support pilot-to large-scale production needs. An efficient module based technology transfer methodology ensures that process transfer and scale-up is executed in a systematic fashion to meet customer's timelines. This entire process is reinforced by global R&D, technology transfer, manufacturing and supply chain operations which ensure that key technologies, materials and resources are leveraged effectively to meet project deliverables. The presentation will highlight the key components and philosophy critical to successful technology transfer into a flexible, high throughput, multiproduct and multi-scale manufacturing facility.
Dr. Senthil Ramaswamy, Team Leader, Downstream Manufacturing Science and Technology Group, Lonza Biologics |
“How to upgrade an existing biowaste decontamination installation?”
This talk aims to outline a process for analyzing system options and making decisions about the choice of the best biowaste treatment methods in terms of existing data, extra requirements and corresponding costs.
Mr. Romuald Rostren, Sales Manager, Asia & Oceania, Actini Asia |
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"Using statistical tools to evaluate execution of validation protocols"
Presentation of how statistical tools can be used to analyse and provide evidence of validation of equipment and processes. The presentation during the breakout session will examine various tools available to analyse data generated during execution of validation protocols and provide several examples of how to use some of the tools available.
Mr. Brad Roberts, Partner & Senior Consultant, SeerPharma, Australia |
"Saving costs and benefit the environment: How the pharmaceutical industry can recover waste heat"
Heat energy, lost to the environment as "waste heat", is generated during industrial processes. This “free, abundant” output can be harnessed and converted into a useful energy source. The potential to use it as a powerful economic resource is unlimited. In the presentation, we will discuss how to grade and recover heat energy at different levels (from 85°C to 600°C) and how to apply them. The temperature, instead of the amount, determines the quality of useful recovered heat. The higher the temperature, the higher the quality and cost effectiveness will be. Also in the discussion are the methodology and economics involved.
Mr. Michael Khong Weng Wah, Senior Manager, Head of Department Energy, HVAC & R and Research and Applications, Cyclect Electrical Engineering Pte. Ltd
Ms. Gayle Tan, Business Development Manager, Cyclect Electrical Engineering Pte. Ltd |
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| 1300-1400hrs |
Lunch |
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COMPLIANCE AND QUALITY MANAGEMENT |
INNOVATIVE COST REDUCTION TECHNOLOGIES / HOT TOPICS |
| 1400-1730hrs |
“A recommended model for risk-based inspection planning in the GMP environment”
Like many regulators, the TGA is looking into options to use the limited inspection capacity in the most effective way. One way to do so, is to apply the generic principles of risk assessment into the inspection scheduling process. PIC/S has developed a guidance document to achieve this. The principles laid down in this model may also be of interest to pharmaceutical manufacturers, as they may use similar principles to schedule supplier audits in their vendor approval system.
Mr. Anton Norder, Quality & Technical Manager, Office of Manufacturing Quality, Therapeutic Goods Administration, Australia |
"Energy efficient ACMV systems in the ASEAN region”
The presentation will address the regulatory framework defining ACMV design, with insights on developing this into Energy efficient design - criteria, sizing and system selection. The talk will also provide insights on operating and maintenance strategies to maintain and optimize the system.
Mr. Jack Lyons, Operations Manager, Life Sciences’ Department
Mr. Richard Habin, Head, Mechanical Department, M+W Group, Singapore |
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“Strategic Management and Implementation of a Product Quality Review (PQR) Programme”
Product Quality Review (PQR) is a top GMP deficiency category with regulators worldwide. This presentation will focus on regulatory expectations on PQR; key elements of an effective PQR program; benefits of PQR, i.e. what’s in it for the manufacturers and recommendation for implementing a strategic PQR program.
Ms. Gloria Pang, Senior Consultant, SeerPharma, Singapore |
“Process Compatibility of Hydrogen Peroxide Vapour for Surface Sterilisation”
The use of hydrogen peroxide vapour (HPV) for high level disinfection of the environment in aseptic processing isolators and enclosures is not new, and is now being used increasingly for ‘surface sterilization’ of indirect product contact parts. There is a greater focus on process compatibility particularly on the oxidizing potential of HPV, its impact in biologics manufacture and methods of residual measurement. This presentation will address the following issues: overview of the process and safety concerns of outgassing; process compatibility of HPV residuals; optimised HPV process to avoid excessive residuals; residual removal and de-gassing rates; analytical methods used to determine H2O2 residuals and characterisation studies to bench mark the HPV process. Examples of the latest techniques will be given.
Mr. Don Bissell, Managing Director, Bioquell Asia Pacific Pte Ltd, Singapore |
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Tea Break |
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“How to get the most out of Supplier Support for Equipment and Computer Validation: Strategies for suppliers to maximize business and for users to minimize validation cost”
FDA's and industry task forces recommend leveraging vendor support for equipment qualification and computer system validation. For example GAMP 5 states: "Although the responsibility for compliance with GxP regulations lies with the regulated company, the supplier may have considerable involvement in the process. Regulated companies wish to leverage supplier knowledge and documentation". Regulated companies are unsure what and how much validation support they can expect and ask for, suppliers on the other hand are unsure what the exact expectations of the regulated users are. In this presentation the audience will learn about responsibilities of vendors and users for equipment qualification and software validation; FDA and international requirements for supplier/user agreements; criteria for selecting the right supplier for regulated environments; claims vendors can make about software compliance; what suppliers should offer to regulated users; help during design qualification of equipment and computers; assistance for supplier assessment; leveraging suppliers hardware and software testing for users tests; the importance of vendor services for (preventive) maintenance and documents that should be provided by the supplier.
Dr. Ludwig Huber, Chief Advisor - Global ISO 17025 and FDA Compliance, LabCompliance, Germany |
"Master Planning Established Multi-Product Secondary Pharmaceutical Manufacturing and Development Facilities”
The presentation will identify a proven three step methodology for facility master planning involving data gathering, option development, selection, and costing. It will discuss the importance of involving key stake holders, canvassing opinion and achieving common consensus on numerous subjects, including the identification of the issues concerning existing products and technologies, and the impact of the introduction of new products, new emerging technologies and manufacturing volumes on existing facilities. The presentation will also highlight the importance of using production forecast and process route data to generate capacity models of future manufacturing operations, and hence identify potential facility development road maps.
Mr. Austin Lock, Biopharma Technical Specialist, PM Group |
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| 1730hrs |
- End of Conference - |