How to Interpret 21 CFR Part 820
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Consumers often must trust their life to a medical device. To ensure such devices are safe and effective, the Food and Drug Administration (FDA) established quality system regulations under the Code of Federal Regulations, Title 21, Part 820. According to Part 820, the quality requirements apply to "the methods, controls and facilities involved in the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished medical devices intended for human use." Following the requirements also ensures compliance with the Federal Food, Drug and Cosmetic Act.
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Continuous Manufacturing in Pharma: Beginning to Snowball? _________________________________________________________
Christine Moore, PhD, Deputy Director for Science and Policy for CDER's Office of New Drug Quality Assessment, recently delivered a presentation whose mission was clear: to convey that the regulatory framework is in place to adopt continuous manufacturing methods, and that FDA is in full support of manufacturers who wish to do so.
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Differentiating Between Validation Testing and Other Usability Testing _________________________________________________________
In March 2010, IEC 62366:2007, "Medical Devices-Application of Usability Engineering to Medical Devices," went into effect, and compliance to this standard is now required by the European regulatory bodies.According to this document, medical device manufacturers must demonstrate that all potential use-related hazards in their devices have been identified, tested, and mitigated. The device must also be shown to be usable by the target population in the intended environment.
These requirements reflect an overall movement toward reducing risk to patients by ensuring that medical devices incorporate good human factors engineering practices. This in turn has prompted device manufactures to learn the differences between typical usability testing and usability testing for regulatory approval.
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Corrective and Preventive Actions: Closing the Loop _________________________________________________________
Implementing effective and comprehensive CAPA in a timely manner continues to be a major problem among medical device, pharmaceutical and biological companies. The lack of follow-up and close-out are frequently mentioned. According to recent trends, approximately 30% to 50% of all citations are CAPA-related.
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Registration is Open! 2-day Workshops on CAPA and Documentation __________________________________________
Is your company ready for an FDA audit? Do you need assistance correcting and preventing non-conformances or conducting a root cause analysis? Or how to write an effective investigation report? PathWise public training workshops can help.
This coming year, we are pleased to offer a suite of Documenting Investigations and Corrective and Preventive Action quality training workshops, located across the globe to fit any schedule or budget.
View events in your area.
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Community Poll: Failure to Document is most common reason for Form 483 issuance in CAPA
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A warning letter has the potential to create disastrous effects for quality management teams and life science companies in general.
Last month we issued a poll asking the most common reason for FDA Form 483 issuance in CAPA. Here are the results from life science organizations worldwide:
1 - Failure to document all required activities (38.9%) 2 - Failure to verify or validate (27.8%) 3 - Failure to investigate the root cause of nonconformities (16.7%) 4 - Failure to identify actions needed to correct and prevent recurrences (11.1%)
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Monthly Newsletter
PathWise, Inc.
November 2010 |
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Upcoming Events
CAPA Workshops for Life Sciences
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.
February 16-17, 2010
Orlando, FL
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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