Global Compliance Trainings, 201,N Squirrel road, Suite 1007, Auburn Hills, Michigan United States - 48326.
11-03-2014
Webinar Description :
Describe the North America Commercial Nuclear successful method used method greater than twenty years and how it is applied in any industry using SOP (controlled and regulated) documents to describe instructions to complete work tasks.
Objectives of the Presentation:
Understand the method to achieve SOP adherence
Learn what steps are needed to implement the method to achieve SOP adherence
Bring your organization into compliance with following SOP, as well as, other controlled instructions, such as job aids.
Why you should attend: “Not Following SOP” is and has been a predominant top 10 (ten) finding by the FDA over the past twenty years. North America Commercial Nuclear for has used a successful method greater than twenty years; learn how to apply and achieve SOP adherence for your organization. Without SOP adherence your organization lacks proper control and is out of compliance with federal regulations. Areas Covered: Quality Assurance, Human Factoring, Technical Writing, SOP Adherence, Auditing for non-compliance to SOP adherence Who will benefit: All organizational staff and consumers Instructor Profile Amy M. Peterson, MS has 18 years of quality assurance (QA) experience in the biotechnology / pharmaceutical industries. Her most recent years have been focused on bringing an understanding of how to take quality to the next level of robustness. She has extensive expertise in: - MANAGING HUMAN ERROR - Designing robust QA systems, including the enhancement of a systems to MEASURE EFFECTIVE CORRECTIVE ACTION/PREVENTIVE ACTION (CAPA) - Designing quality systems which account for human system interaction, preventing human error from leading to a deviation (i.e., event, excursion, exception) that carries consequences. She has adapted, implemented and evaluated an engineering and psychology based approach to managing human error in industry with parallel success to the North America Commercial Nuclear Industry where the approach was collaboratively developed by academics, industry and regulatory experts; now proven successful for 20+ years. Trained/mentored by a colleague with 25+ years of experience working in North America commercial nuclear. MENTOR is a: Senior Reactor Operator (SRO) Nuclear Regulatory Commission (NRC) Certified expert in Human Error Management This specialized expertise with it’s application to CAPA effectiveness has tremendous benefits for all high risk industries to provide error free services. Amy’s background also includes: evaluating and creating new quality systems, product and system data analyses, Consent Decree remediation, product recall management, 483 responses, designing and implementing training systems, technical writing for controlled, instructional documents Live Session for one participant Price: $225.00 Corporate Live Session 4 to 10 participants in single location. Price:$885.00 Recorded Session Access recorded sessions only for one participant unlimited viewing for 6 months. Price: $275.00
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