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John Robinson
  • Fremont, CA
  • United States
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ISO 14971: 2012 and IEC 62304: 2006 mitigate risks in medical device software

ISO 14971:2012 and IEC 62304:2006 are related but different global standards for risk management pertaining to software used in medical devices. Judicious application of these two standards is the way to go for medical device companies.ISO 14971 and IEC 62304:2006 are global standards that govern risk…See More
Jan 13
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Jan 10
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Software Validation Process for 21 CFR Part 11

Software Validation Process for 21 CFR Part 11 is all about authenticity and integrity of electronic signatures and records. Care should be taken to avoid confusion and get validation right.The FDA’s Code of Federal Regulations (CFR) is a collection of laws that regulate the various government agencies. Different…See More
Jan 6
John Robinson posted an event
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GMP requirements for quality control and contract laboratories 2017 at The Leela Mumbai,Andheri Kurla Road, Sahar Village, Andheri-Kurla Road, Mumbai, Maharashtra 400059

January 23, 2017 at 9am to January 24, 2017 at 6pm
Overview:Quality control and related contract laboratories are considered at high risk because after testing and approval, drug products and Active Pharmaceutical Ingredients (APIs) are released to the market without further check. That's the reason why the FDA and other agencies put highest emphasis on inspections of QC laboratories. Even though cGMP regulations have been in place since long time, the large number of QC related 483's and warning letters demonstrate that companies have problems…See More
Aug 9, 2016
John Robinson posted a blog post

Effective Steps for Validation and 21 CFR Part 11 Compliance (CSV)

If one were to define validation; it can be considered the deed of testing an item or system for the level or extent to which it complies with a standard that it has to show compliance with.In the case of computer systems, validation is a major requirement for these regulatory bodies/practices:o The US FDAo European Medicines Agency (EMA)o Good Manufacturing Practices (GMP)o Good Laboratory Practices (GLP)o Good Clinical Practices (GCP)o All the Predicate RulesReasons for which Computer Systems…See More
Jun 6, 2016
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Profile Information

Area of Expertise or Interest?
GlobalCompliancePanel focuses primarily on providing extensive and quality training in these core areas and anything related to them:
Risk Management
Regulatory Compliances
Corporate Governance
Quality Management
Type of Affiliation?
Industry
Years of Experience in MedTech Field
10

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John Robinson's Blog

How to build a complete Safety, Health & Environment Management System through Standards & Practices 2017

Posted on February 15, 2017 at 6:24am 0 Comments

 

Course "How to build a complete Safety, Health & Environment Management System through Standards & Practices" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC…

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The Design History File (DHF), the Technical File (TF) and the Design Dossier (DD)

Posted on February 13, 2017 at 7:29am 0 Comments

The Design History File (DHF), the Technical File (TF) and the Design Dossier (DD) are core regulatory documents for a medical device. This is how one can understand the central difference between them: the Design History File (along with Design Control), is the most important among the regulatory documents that the FDA requires for medical devices, while the Technical File and Design Dossier are documents that serve the same purpose, however, within the EU’s regulatory…

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Preparing premarket submissions that win regulatory approval

Posted on February 10, 2017 at 4:19am 0 Comments

Preparing premarket submissions that win regulatory approval is a complex task, even for the most seasoned professional in the medical devices industry. This is because of the highly stringent nature of the regulatory approval pathways, namely the Premarket Approval (PMA) process and…

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At 10:49am on October 31, 2014, FRANK KWABENA said…


Good Day,

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Thanks God bless.

Mr Frank.

At 8:52am on August 20, 2014, David Hurley said…

Hello my good friend,

How are you? I have something very vital to disclose to you, but I found it difficult to express myself here, since it's a public site. contact me through my email: david.hurley27@yahoo.com

David Hurley.

 
 
 

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