FDA Plans Modest Changes to Medical Device System _________________________________________________________
The Food and Drug Administration is laying out plans to update the 35-year-old system used to approve most medical devices, which has been subject to increasing criticism by public safety advocates.
The agency announced a series of changes it plans to make this year, including streamlining the review process for some low-risk devices. But regulators said they will delay a decision on the most drastic proposals, which would give the government new power to police device makers. Read complete article. |
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Curious about ICH Q9 and ISO 14971 but don't have time to read the fine print? In this webinar, industry experts Ed Bills and Siobhan Yeh share the key differences between the most common pharmaceutical and medical device risk management guidances and what aspects companies should be aware of.
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How Risky is Risk for Regulated Life Science Companies? _________________________________________________________
The simple word "risk" is certainly one of the most frequently used terms in the life science companies today. It has become a cliché to say that the FDA advocates a "risk based approach." Risk Management, Risk Assessment and Risk Mitigation are staples on the menus of virtually every life science conference and exhibition.
But what the heck is "risk"? Should the very nature of "risk" in and of itself really matter to life science companies on a level beyond scenarios of potential harm, SOP creation and record generation?
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Pharma: If QbD is the Map, then PAT is the GPS _________________________________________________________
There have been a number of recent articles highlighting the disappointing adoption rates of PAT and QbD within the pharmaceutical industry. With most new ideas and new technologies, making the leap from innovators and early adopters to the early majority requires the complexity of the product to be significantly reduced to make the product accessible and the value obvious.
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Suggested Reading for Life Science Manufacturers _________________________________________________________
Few things in life are predictable, but there is one event that you can certainly bet on. If your firm manufactures drugs or devices for sale in the United States, the FDA will, at some time, inspect your company. A negative determination could affect your ability to sell products in the United States and damage relationships with your stakeholders.
There are numerous publications that regulatory and quality officials should read to prepare for an inspection. These are just a few of them.
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Poll: Which area of your quality system needs the most focus in 2011? _________________________________________________________
With every new year comes opportunity for improvement, and as quality system professionals, we have a pretty good idea where our efforts should be aimed.
Which area of your quality system needs the most focus in 2011?
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Monthly Newsletter
PathWise, Inc.
January 2011 |
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Upcoming Events
CAPA Workshops for Life Sciences
These 2-day courses, taught by former FDA Investigators, PathWise, and MasterControl industry experts, are designed to meet the requirements mandated by regulatory agencies to effectively investigate and locate causes and correct them.
February 16-17, 2011
Orlando, FL
March 23-24, 2011
Salt Lake City, UT
August 3-4, 2011
Boston, MA
PathWise Webinars
Integrating ISO 14971 and ICH Q9 into the Quality System
This webinar provides insight into the necessary industry standards and offers meaningful techniques that risk management professionals can use to implement ISO 14971 and ICH Q9 into their quality system.
For more information or to purchase.
_________________ Integrating FDA and Trending Requirements into your CAPA System
This session offers attendees a "how-to" approach to effectively integrate the FDA's CAPA and Trending requirements, providing them with the skills necessary to develop a strong, sustainable and compliant CAPA system.
For more information or to purchase.
Conducting OOS and Non-Conformance Investigations This webinar provides a process to effectively expedite and document OOS and non-conformance investigations to increase compliance in your organization.
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