August 2008

Feature Article:

FREE REPORT AND WEBINAR FROM THE ABERDEENGROUP: The Cost of Quality - A Study on Life Sciences

For Pharmaceuticals:

An Analysis of Heparin, Accountability and Pre-emption Where Are We Now? Part II

For Medical Device:

Global Harmonization Task Force Final Document: Role of Standards in the Assessment of Medical Devices

For Blood & Biologics:

Choosing the Right Tool for Quality Improvement Labs

For Quality Groups and Auditors:

Harmonization of Quality Groups and Automated Quality Audit Systems

Playing Havoc:

Are you prepared to handle the impact of severe weather conditions on the biological products in your workplace?

Did You Know?

Did you know that using software-as-a service will serve as a primary submission management solution?


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FREE REPORT AND WEBINAR FROM THE ABERDEENGROUP

The recently published report, The Cost of Quality: a Study on Life Sciences, is a benchmark study by the AberdeenGroup. The report compares the quality standards and tactics of life science companies from the pharmaceutical, biotechnology, blood/biologics and medical device industries with those of Best-in-Class manufacturers. According to the report, "Aberdeen surveyed 169 companies identifying themselves as life science manufacturers."
In The Cost of Quality: a Study on Life Sciences, Aberdeen set out to determine where life science companies stand in terms of Best-in-Class status and what they can do to "improve performance while still conforming to regulatory bodies so that they may take advantage of practices used by Best-in-Class. The study also addresses the distinct pressures life science manufacturers face in relation to other manufacturer types (i.e., their mandate to provide continual traceability).


For Pharmaceuticals: An Analysis of Heparin, Accountability and Pre-emption: Where Are We Now? Part II

The discussion draft of the FDA Globalization Act of 2008 has stimulated a great deal of conversation about ensuring the safety of the U.S. food, drug, medical device and cosmetic supply in the global marketplace. In the second of a two-part series, Christine Humphrey addresses the FDA's inspection initiatives for foreign manufacturers and the agency's stance on pre-emption.



For Medical Device: Global Harmonization Task Force Final Document: Role of Standards in the Assessment of Medical Devices

Q&A discusses the new GHTF final guidance document: Role of Standards in the Assessment of Medical Devices. Multiple questions are also addressed and include the following:

  • What medical devices does the text of the RSAMD final document apply to?
  • Does the RSAMD final document update any previous guidance documents?
  • How are international standards defined in the RSAMD final document?
  • What principles are mentioned in the document for the achievement of harmonization?
For questions about the RSAMD final document contact the Study Group 1 chairperson via the GHTF website.


For Blood & Biologics: Choosing the Right Tool for Quality Improvement

The most important question to ask when selecting a quality improvement tool is,What am I trying to do? What is my purpose? There are five fundamental purposes of an improvement team effort--break down, link together, build up, compare and innovate. For each purpose there are one or two basic tools that make those tasks simple.

For Quality Groups and Auditors: Harmonization of Quality Groups and Automated Quality Audit Systems

The term harmonization has become a buzzword in the life science sector and doesn't just refer to the harmonization of international standards created by various regulatory (or voluntary) bodies but can also refer to the harmonization of company-wide cultural and political differences as well as the harmonization of varying policies and procedures introduced by company mergers and acquisitions.


Playing Havoc: Impact of Severe Weather Conditions in Regulated Environments

Are you prepared to handle the impact of severe weather conditions on the biological products in your workplace?


Did You Know?

Did you know that using software-as-a service will serve as a primary submission management solution?


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