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View Track: Basics & Building Blocks
Basics & Building Blocks
Wednesday, March 26, 2008
B-1: Materials of Construction for the Biopharmaceutical Industry 9:00AM - 10:00AM (Wednesday, March 26, 2008)
The biopharmaceutical industry requires reliable and high quality materials and procedures for the fabrication of components and the erection of systems that include equipment, instrumentation, and piping components. This seminar will focus on aspects of material selection (metallic and non-metallic systems), their performance parameters, the various industry standards, codes and regulations related to the fabrication and application of components, and more importantly, what are the myths and realities associated with these aspects of the industry. We will visit controversial and sometimes misunderstood subjects such as flow velocities, joining methods, product contact surfaces issues such as passivation of stainless steel, the phenomenon of “rouge”, electropolishing, etc.
B-2: Understanding Powder Flow for Formulation Development and Production Process Design 10:15AM - 11:15AM (Wednesday, March 26, 2008)
Powder flow through bins, hoppers and feeders has an enormous impact on common problems such as “no flow” due to stable powder arches and ratholes, erratic flow or a feed rate limitation . Poor flow can lead to reduced production rates and reliance on operators for process control. Understanding powder flow is critical avoiding these problems, and can be used as the basis for new equipment purchases or assigning product production to existing process areas. Examples behavior for common powders will be discussed, including some typical materials of interest to the biopharmaceutical community such as cell culture medias and buffers , as compared to more common powders such as (e.g., sugar, microcrystalline cellulose).
Speaker:
Roger Barnum - Senior Consultant, Jenike & Johanson, Inc.
B-3: Basics and Building Blocks of C & Q 2:00PM - 3:00PM (Wednesday, March 26, 2008)
Commissioning and Qualification (C&Q) costs and schedules are of increasing concern for capital projects. The paradigm is shifting with the increased focus on science and risk based approaches to C&Q and the new ASTM Standard for specification design and verification of pharmaceutical manufacturing facilities and equipment. This paper provides an insight into these new developments and their impact on the execution of C&Q and the potential for cost reduction. The increased focus on risk and risk assessment, use of good engineering practices and implication of the standard will be discussed with some examples.
This session provides an overview of cleaning validation strategies and methods for pharmaceutical processes. Principles and concepts employed in the design and implementation of an effective cleaning validation program, cleaning validation study design and implementation, analytical techniques, establishment of acceptance criteria, and single versus multi-product issues will be presented. This session is designed to provide a basic knowledge of cleaning validation for personnel who are new to the industry or experienced personnel who want to review cleaning validation technology. Validation personnel, engineering, operations and quality assurance personnel and anyone who designs, executes and evaluates cleaning processes and cleaning validation studies will benefit from this program.
B-5: Beyond CAPA: Using Risk Assessment to Streamline your CAPA Process 9:00AM - 10:00AM (Thursday, March 27, 2008)
In this session, we will talk about how to reduce the number of CAPAs within a quality and compliance system using Risk Assessment Methods. Session covers the concept of how applying Risk Assessment can filter out the critical from non-critical issues, techniques for identifying and automating Risk, the concept of Risk mitigation as a measure of verification and effectiveness, and real-world examples of how this Risk-Based CAPA process is being used.
B-6: PAT: The Key to Successful FDA Regulated Manufacturing in the 21st Century 10:15AM - 11:15AM (Thursday, March 27, 2008)
There have been a great many changes in the FDA's guidance for manufacturing in the past 5 years. The publication of their “Pharmaceutical cGMPs for the 21st Century” in 2002 caused the greatest change in compliance guidance since the issuance of the original GMP documents in the late 1970s. Gone are the requirements for mounds and mounds of paperwork that were required to show the exhaustive testing needed to meet the “old” GMP guidance, replaced by the new “design quality in” concept. This concept is not new, but the new guidance documents from the FDA give direction and insight into how the agency expects manufacturers to design this quality into their processes. The need to understand the manufacturing process and provide that feedback into the control system is at the core of this new approach, and PAT is the methodology that gives manufacturers this understanding and control. This presentation describes how PAT supports the quality by design, continuous operation in a regulated industry and real time product release initiatives that are being driven by the new FDA guidance
Supply Chain excellence has become a core requirement in today’s global outsourced pharmaceutical industry. This course covers the basics and summarizes best practices.
• Pharmaceutical Supply Chains unique challenges • Supply Chain Visibility, Trace & track, E-Pedigree • Cold Chain and condition monitoring • RFID and sensors • Regulations and Standards
B-8: RFID in Pharma and Life Sciences: What You Need to Know 3:15PM - 4:15PM (Thursday, March 27, 2008)
This one hour session will give you a comprehensive overview of what RFID is and how it works. You will learn what are the essential components needed to make up an RFID system, such as tags, readers, antenna, printers and software and how they interoperate with each other. We will discuss why RFID is being talked about so much and how it can potentially change your business. Topics covered include how RIFD can be used for Improved Inventory Management (Including Product Life Cycle), Mass Serialization, Product Authentication and E-Pedigree, Chain of Custody, Anti-Counterfeiting, Contamination Control, Compliance with Government Regulations and Product Recall Management. This session will showcase all of the latest Case Studies on how and where RFID is being piloted and deployed by some of the biggest and most innovative pharmaceutical companies in the world. Come and see for yourself how pharmaceutical companies around the world are using this powerful technology to transform their businesses, save money and insure patient safety.
Speaker:
John Jordan - President, WW Field Operations, TAGSYS RFID
