Free Webinar Download: Investigator Responsibilities - Protecting the Rights, Safety, and Welfare of Study Subjects
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Make sure you know and understand FDA expectations regarding supervision of clinical trials and protecting the rights and safety of study participants.
This half-hour webinar provides efficient and effective solutions in complying with the FDA guidance. Interactive features of the presentation include instant polls and a
question-and-answer session.
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Company-Wide Quality Management Systems: How Do They Differ? __________________________________________
Before discussing company-wide Quality Management systems, it is necessary to define the definition of Quality Management (QM). Many organizations and other groups of individual people have attempted to define QM.
There are several different operational definitions of quality that are commonly used in many industries. The most common definition of QM is that it is an integrated approach to achieve and sustain high quality output, focusing on the maintenance and continuous improvement of processes and defect prevention at all levels of the organization, in order to meet or exceed customer expectations.
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How to Avoid & Respond to FDA Warning Letters
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No regulated business wants to receive an FDA Warning Letter (or Form-483) of Inspectional Observations. In such controlled industries as food, agriculture and pharmaceutical, receiving a list of deficiencies can feel like a heavy blow to your quality system. Worse, with the 2009 increase in enforcement staff and the September 2009 change to the response time-now 15 days-the FDA appears to be ramping up its enforcement mandate.
Read complete article. |
Quality System Management: Re-Writing Procedures Alone is Not Always the Answer __________________________________________
Quality Management Systems, such as ISO 9001, serve as the foundational building blocks for an organization and provide well defined and documented procedures which improve the consistency of outputs. Yet, the Quality Management System alone cannot accomplish a system of closed loop corrective actions and instituted lessons learned.
Read complete article. |
Community Poll: What Percentage of Your Quality Investigations are Repeats?
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Repeat CAPA investigations are arguably one of the largest areas of concern for Life Science organizations today. Despite many firms taking the recommended corrective action, repeat investigations throughout the industry have accounted for as many as up to 30% of all open investigations- or 1 in every 3.
What percentage of your quality system investigations are repeats?
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Last Month's Poll Results: CAPA is Area of Quality System Requiring Most Improvement
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Last month, we issued a poll asking "Which area of your quality system requires the most improvement?"
Here are the results from the life science manufacturers worldwide:
#1 Corrective and Preventive Action (CAPA)
#2 Change Controls
#3 Design Control
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Monthly Newsletter
PathWise, Inc.
May 2010 |
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.
June 16-17, 2010
Boston, MA
Tokyo, Japan
September 15-16, 2010
Newport Beach, CA
October 27-28, 2010
San Francisco, CA
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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