How to Comply with ICH Q7
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The Active Pharmaceutical Ingredients Committee recently issued a "how-to" document that outlines the actions needed to comply with ICH Q7.
Specific guidance is provided in the areas of validation, change control, compliant handling and quality management to better assist pharmaceutical companies in meeting this requirement.
Download the guide. |
A Sneak Preview of FDA's Human Factors Standard
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For nearly two decades, the Association for the Advancement of Medical Instrumentation's (AAMI) human factors standard, HE 48, has been the only existing medical device user interface design standard.
With increased emphasis by global regulatory agencies on eliminating and controlling use error in devices, a new human factors standard with more direct relationship to healthcare contexts has been developed by the AAMI Human Factors Standards Committee. In this article, Pat Patterson and Robert North offer a preview into the new standard and how it applies to manufacturers.
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FDA Increases Warning Letters for Pharmaceutical Companies
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The increasing trend in the frequency of issued warning letters referring to CFR Part 211 continues: In Fiscal Year 2009, even more pharmaceutical companies received a warning letter than in the previous fiscal year. Investigation & documentation discrepencies continue to prove most common problem areas.
Read the full report. |
Community Poll: What is the most common tool your investigators use when conducting a root cause analysis?
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Analysis of root cause is a primary area of concern when addressing nonconformaties and deviations in life science organizations today.
In your opinion, what is the most common tool your investigators use when conducting a root cause analysis?
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Last Month's Poll Results: FMEA Most Common Tool for Managing Risk
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Last month, we issued a poll asking "What tool do you find most useful when managing risk?"
Here are the results from the life science manufacturers worldwide:
#1 Failure Modes Effectiveness Analysis - 72%
#2 Fault Tree Analysis - 11.1%
#2 Risk Mapping - 11.1%
#3 SWOT Analysis - 5.6%
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Due to local demand, PathWise is now offering it's 2-day Corrective and Preventive Action training in Boston. The event, to be held April 14-15, will cover such areas as Issue Review, Root Cause Analysis, Vertification and Effectiveness Checking and include insight from MasterControl and former FDA Investigator, Dannie Rowland.
View the workshop agenda | |
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Monthly Newsletter
PathWise, Inc.
February 2010 |
CAPA Workshop for Life Sciences
April 14-15, 2010
Boston, MA
This 2-day course, taught by former FDA Investigators, PathWise, and MasterControl industry experts, is designed to meet the requirements mandated by regulatory agencies to effectively investigate and locate causes and correct them.
For more information or to register.
Effective Risk-Based CAPA Investigations Based on the New GHTF Guidance Document
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.
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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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