is being presented by Marcus Yoder, Senior Manager, with Kalypso and airs on Tuesday, May 25th, 2010. For more details or to register, please visit our site at www.fxconferences.com
Many medical device companies today have multiple design and development sites performing globally but operating in separate quality management systems (QMS) for product-related processes such as design, manufacturing, distribution, and service. To improve efficiency, consistency, and ease of information transfer, companies should move to harmonizing these systems in one global QMS.
This audio conference discusses ways in which for medical device companies can establish and manage an effective global QMS. Drawing on the results of a research benchmark study involving leading medical device manufacturers, this session looks at how companies are optimizing QMS processes to deliver business benefits and measure quality performance globally.
Friday, April 30, 2010
Thursday, April 29, 2010
Best Practices for Managing In-Country Translation Reviews
is being presented by Andres Heuberger, President, of ForeignExchange Translations, and airs on Thursday, May 27th, 2010. For more details or to register, please visit our site at www.fxconferences.com
It's challenging enough for manufacturers to deal with evolving EU regulations, never mind that your head is spinning from coordinating the reviews of multiple translated components in numerous countries!
Internal politics, miscommunication across time zones, and vacation schedules can make translation reviews an expensive and time-consuming process. Rather than shifting responsibility overseas or skipping reviews altogether, attend this advanced audio conference.
With proper planning, open communication, and strong vendor relationships, it is possible to reduce turnaround time, keep translation costs manageable and even avoid a few headaches. This presentation shows you how.
It's challenging enough for manufacturers to deal with evolving EU regulations, never mind that your head is spinning from coordinating the reviews of multiple translated components in numerous countries!
Internal politics, miscommunication across time zones, and vacation schedules can make translation reviews an expensive and time-consuming process. Rather than shifting responsibility overseas or skipping reviews altogether, attend this advanced audio conference.
With proper planning, open communication, and strong vendor relationships, it is possible to reduce turnaround time, keep translation costs manageable and even avoid a few headaches. This presentation shows you how.
Monday, April 26, 2010
Process Validation for Medical Devices
is being presented by Dan O'Leary, President, Ombu Enterprises and airs on Wednesday, May 19th, 2010. For more details or to register, please visit our site at www.fxconferences.com
Process validation is an integral part of any manufacturing system, but is especially important for medical devices, where regulations (FDA QSR and ISO 13485) lay out the requirements manufacturers must follow. It applies when a company cannot, or does not, perform 100% verification of the process output – the product. Since you cannot verify all of the product produced by the process, you need another way to ensure the process produces good output – process validation. Regulators often expect process validation when a manufacturer uses sampling plans for verification.
This presentation helps attendees understand how to perform process validation. Our speaker defines the concepts, and divides process validation into three phases: Installation Qualification (IQ), Operational Qualification (OQ), and Production Qualification (PQ). The presentation explains how to develop protocols for each phase and write reports that document the results. In addition, the presentation explains the FDA QSR and ISO 13485 regulatory requirements for process validation, and uses FDA Warning Letters to point out some of the problems that can occur.
An effective process validation program can help reduce cost. Validated processes can operate at optimized points – points that eliminate or reduce the amount of nonconforming material. The presentation illustrates the concepts of controlling the process parameters and testing them at challenge points. This approach helps set the process parameters at optimum levels.
Process validation is an integral part of any manufacturing system, but is especially important for medical devices, where regulations (FDA QSR and ISO 13485) lay out the requirements manufacturers must follow. It applies when a company cannot, or does not, perform 100% verification of the process output – the product. Since you cannot verify all of the product produced by the process, you need another way to ensure the process produces good output – process validation. Regulators often expect process validation when a manufacturer uses sampling plans for verification.
This presentation helps attendees understand how to perform process validation. Our speaker defines the concepts, and divides process validation into three phases: Installation Qualification (IQ), Operational Qualification (OQ), and Production Qualification (PQ). The presentation explains how to develop protocols for each phase and write reports that document the results. In addition, the presentation explains the FDA QSR and ISO 13485 regulatory requirements for process validation, and uses FDA Warning Letters to point out some of the problems that can occur.
An effective process validation program can help reduce cost. Validated processes can operate at optimized points – points that eliminate or reduce the amount of nonconforming material. The presentation illustrates the concepts of controlling the process parameters and testing them at challenge points. This approach helps set the process parameters at optimum levels.
Tuesday, April 20, 2010
Optimizing Regulated Quality Systems with Design Thinking
is being presented by Michael Plishka, Principal, with ZenStorming Solutions, LLC and airs on Wednesday, June 2nd, 2010. For more detail or to register, please visit our site at www.fxconferences.com
Roger Martin, Dean of the Rotman School of Management, said, 'When it comes to innovation, business has much to learn from the world of design...business people need to be designers - to think and work like designers and embed design-shop characteristics in their organizations.'
You're in business to bring some product or service to market. Even with a common vision, various departments and their people have different needs. Add the constraints of regulatory requirements to the mix and sometimes it's a wonder anything gets done in an effective and timely manner. Design tinking is a process for understanding needs and embracing constraints, with the goal of synthesizing solutions that bring value. It goes beyond simple objective analysis of a system, to holistic understanding and empathy, arriving at better solutions through collaboration and experimentation. This audio conference will discuss the basics of design thinking and how it can be used to streamline your quality systems bring value to your business.
Roger Martin, Dean of the Rotman School of Management, said, 'When it comes to innovation, business has much to learn from the world of design...business people need to be designers - to think and work like designers and embed design-shop characteristics in their organizations.'
You're in business to bring some product or service to market. Even with a common vision, various departments and their people have different needs. Add the constraints of regulatory requirements to the mix and sometimes it's a wonder anything gets done in an effective and timely manner. Design tinking is a process for understanding needs and embracing constraints, with the goal of synthesizing solutions that bring value. It goes beyond simple objective analysis of a system, to holistic understanding and empathy, arriving at better solutions through collaboration and experimentation. This audio conference will discuss the basics of design thinking and how it can be used to streamline your quality systems bring value to your business.
Thursday, April 15, 2010
Recent Perspectives on Trial Design - Minimizing Patients for Oncology Trials
is being presented by Dr. John Constant, Vice President Scientific Affairs, with PRA International and airs on Wednesday, May 26th, 2010. For more details or to register, please visit our site at www.fxconferences.com
Oncology trials have long been at the forefront of novel design thinking, due in part to the extreme needs and historically toxic or complex therapies for cancer. With the regulatory Critical Path Initiatives and the general urgent need for more efficient clinical development adaptive and other patient – efficient designs are continuing to receive increasing attention and FDA has recently published their long-awaited Guidance on adaptive designs. This session will overview recent developments in oncology design thinking and issues related to adaptive, single arm and Phase I/II designs as used in practice in oncology trials.
Oncology trials have long been at the forefront of novel design thinking, due in part to the extreme needs and historically toxic or complex therapies for cancer. With the regulatory Critical Path Initiatives and the general urgent need for more efficient clinical development adaptive and other patient – efficient designs are continuing to receive increasing attention and FDA has recently published their long-awaited Guidance on adaptive designs. This session will overview recent developments in oncology design thinking and issues related to adaptive, single arm and Phase I/II designs as used in practice in oncology trials.
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