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John Robinson
  • Fremont, CA
  • United States
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John Robinson posted blog posts
yesterday
John Robinson posted a blog post

Rising in one’s career through leadership management

Being a manager is an exercise in continuity. One does not become a manager and stop there. It is important to be, than to become managers. This means that management is a journey, not a destination. Because of this, continuous improvement is needed into this discipline from time to time.Leadership management is needed to improve both the manager’s own self, and with it, the growth of the organization. Leadership management may be defined as the means by which one identifies, manages and…See More
Wednesday
John Robinson posted a blog post

FDA and EU requirements on data integrity and implementation

Data integrity and its implementation in cGMP records are major requirements from the FDA. The FDA considers these as important requirements to ensure the integrity of data in these records. The FDA’s, as well as the EU’s requirements are set out for ensuring both data integrity and its implementation are set out in 21 CFR…See More
Monday
John Robinson posted a blog post

Applied Statistics for FDA Process Validation 2017

The pharmaceutical industry considers Applied Statistics for FDA Process Validation to be of very high importance. In 2011, the FDA set out this guidance for the industry. as part of this guidance, called “Process Validation: General Principles and Practices”, which sets the framework for Process Validation in the pharmaceutical industry, any organization in the pharmaceutical industry has to set up a three-stage process.These are the three stages:       I.           Process…See More
Apr 12
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Mar 2
John Robinson posted blog posts
Jan 17
John Robinson posted events
Jan 16
John Robinson posted a blog post

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
John Robinson posted blog posts
Jan 12
John Robinson posted blog posts
Jan 10
John Robinson posted a blog post

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
John Robinson posted events
Apr 21, 2016
John Robinson posted events
Dec 17, 2015
John Robinson posted events
Dec 9, 2015

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

Leadership Management Academy 201-202: Rising Through the Management Ranks 2017

Posted on April 20, 2017 at 7:20am 0 Comments

Overview:

Why Should You Attend?

By attending, you will take advantage of a great opportunity to advance as a manager to the next level!

Too often, we focus on getting things done and…

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


Good Day,

How is everything with you, I picked interest on you after going through your short profile and deemed it necessary to write you immediately. I have something very vital to disclose to you, but I found it difficult to express myself here, since it's a public site.Could you please get back to me on:( mr.frankkwabena@yahoo.com.hk ) for the full details.

Have a nice day

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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