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In this program you will learn how to apply the best QbD and risk management practices to ensure compliance, patient safety and corporate reputation.
In this program Hedley Rees discusses best practices in world-class contractor management and procurement, and how they can be woven into the fabric of your organization.
More than 20 on-demand webcast presentations from industry experts and leading solutions providers. NIR, Raman and Particle Characterization technologies and applications that are improving pharmaceutical product and process quality.
Hear from insiders how modular construction, new production platforms and single-use technology are reducing the risk, and time, required for new biopharmaceutical manufacturing facility construction and startup. Learn true cost vs benefits, and distinguish between myth and reality in terms of equipment and platform capabilities and versatility. Manufacturing floor issues will also be discussed in depth, individual facility installations will be analyzed, sharing best practices and lessons learned.
Join us for a review and moderated discussion of the issues and technologies driving new pharmaceutical manufacturing facility design and construction, both in the U.S. and in growing Asian markets. Among the questions, in the U.S. are: where are the facilities being built and how will that affect industry employment trends? How are they being designed?
Recent high-profile product recalls and counterfeiting cases have drawn attention to the need for drug manufacturers to work across the entire supply chain to ensure product safety and quality. Join Brian Johnson, Pfizer Senior Director of Supply Chain Security, and consultant Russ Somma, in a webcast discussion of best practices for ensuring supply chain security.
Biopharmaceutical manufacturing is often described as "data rich, but information poor." Focusing on essential data, and making it accessible to those who need it, in the format most useful to them, is the key to improving product quality, ensuring compliance and reducing time to market. What do manufacturers need to do, and how are forward-thinking companies tackling this problem? Join us for a program exploring issues, presenting today's best practices and exploring future solutions.
In this program, Pfizer’s Ciarán Crosbie and BSM’s Lorcan Mannion illustrate how pharmaceutical laboratories can master the concepts and tools of levelling and flow and achieve significant gains. The presentations are based upon successful implementations at Pfizer’s Grange Castle, Ireland facility.
Hear from the legal team that represented whistleblower Cheryl Eckard (Lesley Ann Skillen and Neil Getnick) and from qui tam expert Ken Nolan of Nolan and Auerbach on how to prevent legal liability and what employees need to know before considering whether to blow the whistle on noncompliant practices.
Join us on February 17, 2011, at 11 a.m. ET to learn more about why cleaning validation issues have ranked in the top five for FDA warning letters. With the advent of new online technologies and changes in the regulatory approach to validation, traditional cleaning validation can move more towards a mode of cleaning verification. This presentation will describe the whys and wherefores of cleaning validation with recommendations of procedures and interpretation. Data on a new approach for screening and specific analysis using charged aerosol detection with FIA and UHPLC will be presented. Live Q+A will follow-bring your questions for the experts.
You know you cannot afford to handle the complexities of chargebacks, scalability, and compliance with solutions that don't add value to your bottom line. Considering moving forward with a new ERP solution? Watch this on demand webcast to learn how to avoid the pitfalls, and manage the risk, during all stages of your ERP project, so that you can enjoy the payoffs quickly and (relatively) painlessly.
During this webinar Jeff O'Connor from Lonza will discuss a new approach to plant scheduling operations that enabled the company to reduce batch cycle time 25-30%, increase production throughput 20%, reduce manufacturing risk, improve production leveling and identify and alleviate process bottlenecks. Learn how companies like yours are utilizing this advanced solution to schedule real-world production processes, resulting in more agile and efficient manufacturing-and a healthier bottom line.
Although individual companies are achieving results by implementing Toyota Production System and other Lean methodologies, the pharmaceutical industry's Lean progress has been slow so far. In this program, McKinsey's Ulf Schrader, St. Gallen's Thomas Friedli, and NIPTE's Prabir Basu discuss what's holding pharma back from achieving true operational excellence, and what can be done to achieve lasting results and culture change, especially in an atmosphere dominated by mergers and acquisitions, downsizing, outsourcing and offshoring.
For those considering incorporating the PTS/MCS into their manufacturing and testing processes, this webcast will cover the details of implementation and its benefits. Attendees will also hear from a Charles River customer about their experiences switching to these rapid testing technologies, including how it impacted decision-making, validation and final outcome.
As expectations for product quality and safety have risen, contract partners must maintain a seamless and compliant working relationship—with the ultimate goal of jointly minimizing risk via comprehensive risk assessment, and effective risk control. This one-hour program features presentations by three industry experts on the topic: consultant Russ Somma, Abbott's Richard Poska, and Roche/Genentech's Franco Pasquale.
Pharmaceutical manufacturers today are challenged to keep up with market growth and changes. A quick look at FDA's reporting on "out of stock" pharmaceuticals gives some indication of the size of the problem. A preconfigured information management solution is now available to meet the needs of pharmaceutical businesses as they grow. In this live webcast, Convatec CIO William Compton explains how his company implemented this solution, under an aggressive schedule, and what has been achieved so far.
Webcast: Taking a "Real World" Approach to Analytical Method Validation and Transfer: Best Practices from GSK
Disconnects between laboratory and plant floor lead to millions of dollars in wasted pharmaceutical analytical method validation and transfer efforts each year. However, using Quality by Design principles, and taking a life-cycle approach can help ensure that method validation and transfer are right the first time, every time.
To avoid costly shutdowns, product seizures, and warning letters, drug firms need effective raw material controls and critical supplier auditing procedures. Imagine how effective your controls would be if you were using the same exact field sampling techniques and tools FDA investigators use. If you’d like to learn some of the lessons the FDA has adopted in the wake of the contaminated Heparin and Glycerin scandals, then attend this free webinar hosted by Thermo Fisher Scientific.
SAP is helping Life Science companies implement comprehensive and proven industry specific solutions that manage business processes in one preconfigured Life Science industry solution. Join us to learn how Convatec implemented an SAP Life Science industry solution using industry best practices and rapid deployment methodologies to meet an aggressive implementation timetable and develop a solid foundation to support future growth in the highly regulated Life Science Industry.
Design for manufacturing is helping to drive continuous improvement in most industries today. Quality by Design, driven by ICH, FDA and other regulatory agencies, aims to take that approach to drug development, to reduce the time and cost of bringing new drugs to market. The past few years have seen pilot QbD programs, case studies for small molecules and biopharmaceuticals and the sharing of information. How far has the concept come in the pharma industry? What will be needed to drive it forward in the future?
Toyota methods may have been designed for the shop floor, but they are leading to significant improvements in the way pharmaceutical quality and even research labs operate. Hear leading consultants--Tadgh Prendeville, BSM USA and Bikash Chatterjee, Pharmatech Associates as well as Margaret Wyche, Director of QC, Allergan share their experiences on increasing efficiency, decreasing waste and improving quality in the lab.
Early adopters of single-use technologies in the biopharmaceutical industry have done so at the expense of some process analytics and process control. As the industry has acquired more experience with disposable bioprocess sensors and systems and as single-use technologies have matured, what has been learned? What advancements and challenges are on the horizon? In this panel discussion format, join experts in discussing the challenges and opportunities that lie ahead as single-use technologies continue to develop to meet the needs of the biopharmaceutical industry.
This program is dedicated to a discussion of maintaining competitiveness and operational advantage in a rapidly changing environment. Three industry experts, Thomas Panzer, VP Global Supply Chain, Bayer Biotech, Hans Engels, CEO, DSM Pharmaceuticals Inc., moderated by Nari Viswanathan, VP Supply Chain Research, Aberdeen Group, will share their thoughts and potential solutions for managing ever increasing industry pressures.
This Oracle and PRISYM ID Webinar examines how serialization helps defend against counterfeiting: using labeling and management solutions to deliver secure and compliant printing for mass serialization, enhancing existing equipment and production lines to cope with changes, and tracking products through the supply chain to improve efficiency.
This webinar featuring Drs. Ian Mutton, PhD, formerly of Glaxo SmithKline, now Founder and Member IEXA100, Rick Cooley, PhD, formerly of Eli Lilly, now Market Development Manager Process Analytics, Dionex Corporation and Bruce Bailey, PhD Product Applications Manager, Dionex Corporation focuses on the challenges of PAT in moving on-line HPLC measurements from QC to process; and addresses the problems of non-UV absorbing analytes using Charged Aerosol Detection.
Outsourcing affords life sciences manufacturers greater flexibility and market responsiveness, and the freedom to focus on core competencies. Outsourcing strategies, however, can vary widely. This webcast will provide an overview of trends and challenges influencing life science companies' outsourced manufacturing strategies, as well as review outsourced manufacturing enabling solutions and technology. The featured speaker will be Tom Blake, who will share outsourcing strategies, processes, KPIs and future direction at Eli Lilly.
Follow-on biologics, or biosimilars, will soon become reality in the U.S. Given their inherent complexity and the current state of analytics, how will their safety and quality be ensured? Will they boost or diminish competition and innovation in biotech? Join us for a thought-provoking presentation and panel discussion of these issues.
Failure to transfer an analytical method or to move a process from lab to plant can cripple drug development efforts, wasting millions of dollars each year. Why do tech transfer projects fail? How can one ensure their success, whether one is transferring to another department or to a contract manufacturing organization? Join us for a controversial presentation and panel discussion of these issues.
Webcast: Fix the Mix: Why Wyeth Turned to SAP Enterprise Inventory Optimization to Meet Supply Chain Targets
The pharmaceutical industry has not been shielded from the competitive dynamics of a "flat world." To remain ahead of their competitors, Wyeth Pharmaceuticals turned to Enterprise Inventory Optimization (EIO) to effectively manage inventory levels, service levels and costs. Join Allen Jacques, leader of Wyeth’s biopharma supply chain, and other speakers in this webcast to learn how Wyeth has leveraged SAP Enterprise Inventory Optimization by SmartOps.
Economic realities and market pressures demand agility in pharmaceutical manufacturing as never before. What technologies promise to transform laboratories and manufacturing facilities as we know them today? What will the typical pharma plant look like in twenty years? In this webcast, experts share their views on transformative technologies, existing facilities that set new benchmarks for the industry and what the future holds. Q & A to follow the speaker's presentations.
Webcast: An Off-the-Shelf SAP and E-Pedigree Solution for Small and Midsize Pharmaceutical Companies
This webcast, sponsored by IdhaSoft and SAP, will share information, ideas and case study experiences for improving operational efficiencies, reducing time to market and maintaining e-pedigree compliance.
In this webcast, companies that are in Lean Six Sigma for the long haul share best practices and the financial results that you can expect. They also address how to get management buy-in for programs that will withstand the test of time.
Webcast: Pharmaceutical Outsourcing: Operational Excellence and QbD for Building Better Partnerships
OpEx and QbD, particularly the ideals of performance metrics and risk management, can be used to strengthen the relationship between partners in all pharmaceutical supply and contract situations. This webcast provides novel ideas and tangible suggestions for improving pharmaceutical partnerships. Speakers include: Russ Somma, PhD, president of SommaTech, LLC; Rakesh Kishan, president of UMS Advisory, Inc.; and Ron Perry, Co-Champion, Wyeth Supplier Quality Excellence Team.
Webcast: Quality by Design and Product Purity: Breaking through Standard Method Validation with the Corona CAD Universal HPLC Detector
Watch this webcast to learn how a new universal HPLC detector, the Corona CAD, has been evaluated for the development of validated methods by several pharmaceutical and biotech companies. Details of the validation of methods will be presented for two sample sets: accurate measurements of a traditional small molecule drug substance, and impurity determinations of a peptide drug product formulated in a mixture of lipids and phospholipids. The Corona CAD methods were rigorously and successfully validated against standard method validation criteria. The data presented here demonstrate that not only can validated methods be developed using the Corona CAD, but that the Corona CAD enables previously difficult analyses, saving time and resources.Back to Top