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ComplianceOnline, Online Event
2013-02-08
This CAPA training related to managing human error in regulated industries will explain the approach used in commercial, nuclear and aviation industries. It will help attendees understand effective CAPA implementation to successfully manage human error in regulated pharmaceutical, biotech and medical device companies.
Long Description: Ensuring effective CAPA and monitoring for assurance has been achieved successfully in two major high-risk industries, North America Commercial Nuclear and Commercial Aviation and Military Aviation. To obtain effective CAPA success it is essential to understand how to manage human errors and commercial nuclear and aviation have invested the time, money and resources to have expertise within their workforce.
This pharmaceutical CAPA training will discuss the effective Corrective and Preventive Actions learned by understanding the evolution of managing human error in nuclear and aviation industries and how to implement these actions in regulated pharmaceutical, biotech and medical device companies and all respective regulatory agencies.
This pharmaceutical, biotech and medical device CAPA training will cover the following topics:
- Deviation reduction (Goal: 0 deviations / batch)
- Achieve effective CAPA (Does “retraining or counseling work?”)
- Understand what is needed to achieve effective CAPA.
- Know why it is critical to manage human error.
- Begin to understand how to manage human error,
- Lessons learned from industries that have used this knowledge for success for 20+ years
- MOST IMPORTANTLY: Ensure PATIENT SAFETY; create cost savings for business / customer
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Organized by:
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ComplianceOnline |
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Invited Speakers:
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Amy M. Peterson, MS has 18 years of Quality Assurance experience in the biotech / pharmaceutical industry. Her most recent years have been focused on bringing an understanding of how to take quality to the next level, which must occur for cost savings and safety alone. She has designed some of the most initial and robust CAPA effectiveness systems; which requires expertise in managing human error.
She adapted, implemented and evaluated engineering and psychology based approach to managing human error in the industry with parallel success to the North America commercial nuclear industry where the approach was developed by academics and industry experts; now proven successful for over 20+ years. She was trained by her colleague with 25+ years of experience working in commercial nuclear, particularly as an expert in creating, training and implementing how to manage human error.
This specialized expertise with its application to CAPA effectiveness has tremendous benefits for the health industry to provide error free medical care, devices and patient care.
Her background also includes evaluating and creating new quality systems; enhancement during urgent product recalls and Consent Decrees utilizing CAPA effectiveness and enhanced internal auditing approaches / system implementation along with principles and tools from Six Sigma, Lean Manufacturing
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Deadline for Abstracts:
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2013-02-07
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Registration:
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http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=702736?channel=Hummolgen
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E-mail:
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referral@complianceonline.com
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