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Critical Medical Device Compliance Training to be held at Disneyland Resort!
Expert Consultants ready to assist with your compliance needs!
Medical Device Regulatory Submissions cleared quickly!
Welcome
Over 25 years of hands-on experience allows us to help our clients navigate the regulatory and compliance issues faced on a daily basis as well as occasional unwanted surprises encountered.
Consulting
Our experience working with FDA / ISO / International compliance & regulatory issues allows us to help our clients meet their regulatory challenges. Quality systems, submissions, technical, audits, etc. 
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Training
10 Courses, July 14-18 at the Disneyland Resort. Important Medical Device compliance topics. Prepare before your next FDA Inspection or Notified Body audit. See our list of one day courses. Take one or more. 
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On-site Training 
Clients find on-site or in-house, private training to be very beneficial  and cost effective for their teams. Courses can be taught specific or customized to the company, products, and processes. 
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Submissions & Audits
510(k) Submissions
CE Mark Technical Files /Dossier 
PMA, IDE, De Novo, etc.
Internal Audits, Vendor audits, Mock FDA Inspections 
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Training Program at Disneyland Resort will cover many critical regulatory topics!
Over a period of 5 days from July 14-18, ten (10) courses will be taught in Southern California on a variety of critical regulatory topics that the U.S. FDA and international regulatory bodies have on their radar during inspections. The subject matter of these courses show up as the top Warning Letter citations and FDA 483 observations after an FDA inspection. Topics range from Quality system compliance (FDA, ISO 13485, Canada), Design Control, Risk Management, Software V&V compliance strategies, Complaint Handling & MDRs, CAPA, Process Validation, Auditing, and Submissions (510(k) and CE Marking). Meet your training requirements and be prepared for your next inspection. Attendees may register for one or more courses. Discounts available. 
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Training / Course Highlights
07.14.2014
Details of FDA Quality System regulation (21 CFR Part 820) will be discussed and followed by how to integrate multiple quality systems (FDA, ISO 13485 & Canada) into one quality system
07.15.2014
Design Control compliance for FDA & ISO will be followed by Risk Management in which both courses will discuss proven techniques for compliance. ENISO14971:2012 discussion will be included.
07.17.2014
Complaint Handling, MDR, CAPA, Process Validation, and Software V&V are very high on FDA's list of Warning Letter citations every year. These are areas you ca