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

Upcoming FDA FSMA Rules on the Sanitary Transportation of Human and Animal Foods

The process of finalizing new food safety rules by the U.S. Food and Drug Administration (FDA) is underway. The accent of these upcoming FDA FSMA rules on the sanitary transportation of human and animal foods is the ways by which scientific and safe transportation and logistics involved in food transportation can be bettered. The FDA is required to establish rules for improving, auditing and enforcing new rules relating to food transportation. Congressional instructions have been issued for…See More
5 hours ago
John Robinson posted an event
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Seminar Calendar of Upcoming Courses - June to July - 2017 at INTERCONTINENTAL HONG KONG

June 1, 2017 at 9am to July 28, 2017 at 6pm
GlobalCompliancePanel’s seminars are a wonderful opportunity for professionals in the regulatory compliance areas to understand the latest happenings and updates in the regulatory compliance areas and to implement them, something they need to climb in their professions. GlobalCompliancePanel brings together a few of the best recognized names in the field of regulatory compliance on its panel of experts. The result: Learning that is effective, valuable and helpful. GlobalCompliancePanel’s…See More
Thursday
John Robinson posted blog posts
Thursday
John Robinson posted a blog post

“Understanding the practical application of statistics?”

The application of statistical methods is specified all through 21 CFR and guidance documents for the pharmaceutical, biopharmaceutical, and medical device industries for these activities:o  Setting validation criteria and specificationso  Performing Measurement Systems Analysis (MSA)o  Conducting stability analysiso  Using Design of Experiment (DOE) for process…See More
May 19
John Robinson posted blog posts
May 17
John Robinson posted a blog post

Key issues in HR auditing

The importance of HR auditing can be gauged from the fact that it is about employees, an organization’s most valuable resource. It is through HR audits that an organization evaluates its strengths and weaknesses of its most important resource. HR audits have come a long way from the earlier times, when they were considered a set of checklists to be ticked. Today, HR…See More
May 15
John Robinson posted a blog post

HIPAA’s compliance expectations from Business Associate

The Health Information Portability and Accountability Act (HIPAA) regards the Business Associate as a major player. HIPAA defines the Business Associate (BA) as either an organization or a person who works with or provides service to a Covered Entity, who in turn is defined as one who handles or discloses Protected Health Information (PHI).So, a Business Associate is any person or entity that is involved in creating, receiving, maintaining or transmitting PHI to a Covered Entity for a purpose…See More
May 11
John Robinson posted a blog post

Article on “Human factors as a factor in medical devices 2017”

The ANSI/AAMI HE75:2009 document describes human factors as the way in which the elements of human knowledge, such as emotional, intellectual, and physical and the sensory are used to optimize the production of devices, systems, and many others concerned with them. Human factors take not only the ways in which these human elements are used to…See More
May 10
John Robinson posted blog posts
May 9
John Robinson posted a blog post

Wrong hiring and ways of avoiding it

A perfect hire is a boon to any organization. At the other extreme, a bad hire can bring the inverse result to the organization: It can not only impede productivity; it can even result in drawing the organization into legal issues associated with wrong hiring. Problem employees create employee problems, which is why HR professionals need to be aware of what steps to take and what scenarios to avoid if they have to take hiring decisions that are legally defensible. A hire that is weak from the…See More
May 5
John Robinson posted blog posts
May 3
John Robinson posted blog posts
Apr 27
John Robinson posted a blog post

Tips and Suggestions on interacting with FDA Officials and Premarket Approval (PMA)

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 FDA regulatory 510(k)…See More
Apr 25
John Robinson posted blog posts
Apr 21
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
Apr 19
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
Apr 17

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

Seminar Calendar of Upcoming Courses - June to July - 2017

Posted on May 24, 2017 at 5:51am 0 Comments

 

GlobalCompliancePanel’s seminars are a wonderful opportunity for professionals in the regulatory compliance areas to understand the latest happenings and updates in the…

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“Understanding the practical application of statistics?”

Posted on May 19, 2017 at 5:52am 0 Comments

The application of statistical methods is specified all through 21 CFR and guidance documents for the pharmaceutical, biopharmaceutical, and medical device industries for these activities:

o  Setting validation criteria and specifications

o  Performing…

Continue

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


Good Day,

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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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