QA Oversight of Contractors

is being presented by Marion Weinreb, President, of Marion Weinreb & Associates, Inc and airs on Tuesday, August 24th, 2010. For more details or to register for this event, please visit our website at www.fxconferences.com

Managing contractors is key to successful operations. As companies continue to outsource processes, the quality agreement becomes critical to supply chain operations. Quality agreements are required by the EU GMPs and are recommended per the International Conference on Harmonization's (ICH) Q10, known as Pharmaceutical Quality System.

This audio conference discusses what a quality agreement is and how to use it as a tool in managing your contractors. It also identifies the key elements of what to include in the quality agreement so that if something goes wrong, responsibilities have been clearly delineated and corrective action can proceed smoothly.

QA Oversight of Vendor Management

is being presented by Marion Weinreb, President, of Marion Weinreb & Associates, Inc. and airs on Wednesday, March 17, 2010. For more details or to register, please visit our site at www.fxconferences.com

Managing vendors is key to successful operations. As companies continue to outsource processes, the quality agreement becomes critical to supply chain operations. Quality agreements are required by the EU GMPs and are recommended per the International Conference on Harmonization's (ICH) Q10, known as Pharmaceutical Quality System.

This conference discusses what a quality agreement is and how to use it as a tool in managing your vendors. It also identifies the key elements of what to include in the quality agreement so that if something goes wrong, responsibilities have been clearly delineated and corrective action can proceed smoothly.

Quality Testing for Complex Medical Devices

is being presented by Lura Wolfe, Technical Quality Engineer & Consultant and airs on Wednesday, March 3, 2010. For more details or to register, please visit our site at www.fxconferences.com

Testing in complex software and hardware environments presents unique challenges in product development, and it is vital that your QA team be being able to meet these challenges and ensure quality. Agile development methodologies were implemented for quick creation and delivery of software, but they introduce new challenges when deliverables keep changing, timetables are shortened, and development complexity rapidly increases.

This audio conference presentation examines the testing methods typically used with complex medical devices. The speaker draws on first-hand experience and provides examples of test plans, test cases, and test lists, and discusses how to use documentation to create, track, and report testing results.

Best Practices for Back Translation as a QA Tool

Back translation is the translation of an already-translated text back into its original language. The use of back translation as a QA tool is becoming more prevalent in the life sciences industries, as often required by regulatory industries. These translated materials include product information, labels, informed consent forms, websites, software strings and a variety of other written content.

The issues presented by this growing trend in back translation are complex and often misunderstood by those removed from the localization process. Back translation as a QA tool can be successfully accomplished when these issues are fully understood and the process properly applied.

Best Practices for Back Translation as a QA Tool was presented by Hilary Davies, Senior Project Manager, with ForeignExchange Translations, and aired on 2008-08-06. For more details or to download this conference, please visit our site at www.fxconferences.com

QA Oversight of Vendor Management

Managing vendors is key to successful operations. As companies continue to outsource processes, the quality agreement becomes critical to supply chain operations. Quality agreements are required by the EU GMPs and are recommended per the International Conference on Harmonization's (ICH) Q10, known as Pharmaceutical Quality System.

This conference discusses what a quality agreement is and how to use it as a tool in managing your vendors. It also identifies the key elements of what to include in the quality agreement so that if something goes wrong, responsibilities have been clearly delineated and corrective action can proceed smoothly.

QA Oversight of Vendor Management is being presented by Marion Weinreb, President, of Marion Weinreb & Associates, Inc. and airs on Tuesday, October 13, 2009. For more details or to register, please visit our site at www.fxconferences.com

Creating Policies and Procedures That Work

If you are a scientist, researcher, QA/QC, or product development expert, sooner or later you have to address critical quality and regulatory issues. And there is no more important component of sound quality and regulatory practices than well-thought-out and well-written policies and procedures.

Sub-optimal policies and procedures can have a significant deleterious effect on an organization -- not just in regulatory compliance but also in overall productivity. And even the most knowledgeable subject matter experts can struggle when creating policies and procedures.

Of course, this is not surprising – after all, framing policies and establishing procedures present significant challenges. What processes should have policies? Why? What procedures should be documented? And how extensively should they be documented? And what are the best approaches to drafting policies and procedures that will make them clear, easy to understand, easy to follow, and – perhaps most important of all – acceptable to regulatory authorities? In this audio conference, attendees learn important strategies to meet these challenges.

Creating Policies and Procedures That Work is being presented by Karl Keller, Principal, with Communication Partners and airs on Wednesday, Sept. 16, 2009. For more details or to register, please visit our site at www.fxconferences.com

Implementing QA Automation in an FDA-Controlled Software Environment

With major changes expected at the FDA, including increased scrutiny of complex medical devices, automating your QA process is more important than ever. This presentation provides medical device software engineering and QA professionals with practical guidelines on how to successfully implement QA automation. The speaker discusses how to select and implement the correct tools, how to validate those tools and how to work with technical teams to develop the cost justification.

This audio conference also looks at why the CDRH Software Forensics Lab recently acquired 5 different static analysis tools, and what this means to medical device makers.

Implementing QA Automation in an FDA-Controlled Software Environment is being presented by Ken Carson, Senior Vice President, Client Services, with Full Spectrum Software, Inc. and airs on Tuesday, August 11, 2009. For more details or to register for this audio conference, please visit our site at www.fxconferences.com

Microcycle Testing: Better eLearning QA in One-Fourth the Time

Conducting quality assurance testing is an important part of developing online courses. A new methodology called "microcycle testing," combined with online technologies, can help you achieve dramatic improvements in productivity during this important, but often overlooked, course development phase.

This audio conference explores how to dramatically compress the time it takes to conduct e-learning quality assurance testing, while at the same time, getting better results.

Microcycle Testing: Better eLearning QA in One-Fourth the Time is being presented by Garin Hess, CEO, with Rapid Intake and airs on Thursday, August 6, 2009. For more details or to register for this event, please visit our site at www.fxconferences.com

Best Practices for Back Translation as a QA Tool

Back translation is the translation of an already-translated text back into its original language. The use of back translation as a QA tool is becoming more prevalent in the life sciences industries, as often required by regulatory industries. These translated materials include product information, labels, informed consent forms, websites, software strings and a variety of other written content.

The issues presented by this growing trend in back translation are complex and often misunderstood by those removed from the localization process. Back translation as a QA tool can be successfully accomplished when these issues are fully understood and the process properly applied.

Best Practices for Back Translation as a QA Tool was presented on 2008-08-06 and is available for download at www.fxconferences.com