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John Robinson's Blog (247)

Where does GMP Training end and HR training begin?

That pharmaceutical companies need to hire professionals with the requisite qualifications is beyond question. This is not only required for the smooth conduct of activities in their course of their day-to-day work, but also because the FDA has set out its requirements for the proper educational and skill set qualification of employees in this profession in 21 CFR 211.25(a).

This FDA section underlines the need for educational qualifications, training and experience to carry out their…

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Added by John Robinson on April 24, 2018 at 7:29am — No Comments

RBI's latest norms makes Paytm happy, leaves Google, Amazon upset

digital payment industry could be thrown into disarray due to the demand by the Reserve Bank of India (RBI) that all user data be stored within the country, fears an industry grouping, which has termed the decision as “heavy-handed”, even as others, including the country’s largest digital payment provider Paytm, have hailed the move.

In a bid to narrow the growing schism, the industry is planning to send a formal…

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Added by John Robinson on April 19, 2018 at 7:25am — No Comments

Immunotherapy transforms lung cancer, the biggest cancer killer

Immune therapy drugs can transform lung cancer treatment, giving patients years of extra life, doctors reported Monday.

They found that pre-treating lung cancer patients with immune therapy drugs before they have surgery can help melt away the tumor and at the same time limit or even stop its spread.

And combinations of immunotherapy drugs have helped other lung cancer patients get off more toxic standard chemotherapy while also extending their lives.

The results are so…

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Added by John Robinson on April 17, 2018 at 7:47am — No Comments

Which can leave the work of meeting regulatory requirements to FDA Services

FDA consulting services are those services that are offered by independent, mostly private companies in helping to meet FDA requirements. FDA consulting services are offered to organizations that have to meet FDA regulatory requirements. Many companies across the US and many other parts of the world specialize in offering FDA consulting services and these are often the main business for these…

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Added by John Robinson on April 12, 2018 at 6:46am — No Comments

What happens when an FDA Form 483 is issued?

One of the chief aims of the FDA is to ensure the protection of public health and making sure that select types of organizations comply with the provisions of the Food, Drug and Cosmetic Act. It enforces these aims by conducting periodic inspections of the facilities and types of organizations that come under its purview. The FDA is empowered by the terms of the Federal Food, Drug, and Cosmetic Act, Sec. 704…

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Added by John Robinson on April 10, 2018 at 7:07am — No Comments

Safe and effective as a non PMA-subjected legally marketed device

A medical device has to mandatorily make a submission for premarket approval (PMA) to the FDA to demonstrate that the device to be marketed is substantially equivalent or at least as safe and effective as a non PMA-subjected legally marketed device. This submission is called 510 (K).

A medical device company has to submit a product for PMA when it manufactures or makes changes and modifications that could substantially affect safety and effectiveness requirements under 21 CFR 807 and…

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Added by John Robinson on April 5, 2018 at 7:00am — No Comments

PharmAbcine Announces FDA Orphan Drug Designation Granted to TTAC-0001

PharmAbcine Inc., a clinical-stage biotech company developing novel antibody therapeutics for multiple cancer indications, announced today that U.S. Food and Drug Administration (FDA) has granted orphan drug designation to its leading clinical compound TTAC-0001 for “treatment of Glioblastoma Multiforme.”

“We are very pleased with this Orphan Drug Designation from FDA for TTAC-0001 for GBM treatment since we have been preparing for clinical studies of TTAC-0001 plus KEYTRUDA®…

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Added by John Robinson on April 2, 2018 at 7:29am — No Comments

How to understand the Pharmaceutical Regulatory Affairs

Regulatory Affairs sit at the center of an industry like pharmaceuticals. Given the importance this industry and the products its manufactures have on the health of human beings; it is imperative that there should be regulations in the industry at every stage of the process of manufacturing and marketing of pharmaceuticals.

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Added by John Robinson on March 26, 2018 at 6:54am — No Comments

Virtual healthcare has to be understood and used for what it can offer

Among the many offshoots of the growth of technology; virtual healthcare is a very recent and important development. In simple language, virtual healthcare, a term easy enough to understand, is the use of technologies that enable remote consultation and monitoring of healthcare.

Putting technologies to remote use has been in use for a while now, what with corporate entities carrying out conferences and virtual conferences at the push of a button. Virtual…

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Added by John Robinson on March 22, 2018 at 7:34am — No Comments

Good Documentation Practices Relating to USP

Good Documentation Practices (GDP) is a quintessential part of regulated manufacturing and laboratory environments. GDP has to be adhered to in the regulated industries because it is the only truly authentic method of ensuring that documents are audited and accounted for. GDP is also essential to keep track of and maintain control at all stages of the process and the product. GDP is thus a core requirement of a thoroughly developed Quality System.…

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Added by John Robinson on March 20, 2018 at 7:13am — No Comments

Stephen Hawking’s secret to surviving his terrible condition

The late-night comic had found his perfect straight man. In June 2014, John Oliver sat down with renowned theoretical physicist Stephen W. Hawking for an interview.

“You’ve stated that there could be an infinite number of parallel universes,” the host of HBO’s “Last Week Tonight,” asked Hawking. “Does that mean there’s a universe out there where I am smarter than you?”

“Yes,” Hawking…

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Added by John Robinson on March 14, 2018 at 7:23am — No Comments

Pharmaceutical Water Systems have to be Designed with a Lot of Common Sense

The effectiveness of a pharmaceutical water system depends on its design. The design is the soul of the system. Any pharmaceutical water system design should come equipped with the ability to serve its most basic purpose, which is to help the pharmaceutical organization meet the set quality.

The importance of water can never be overemphasized. Apart from the emotional, spiritual and cultural value it has; water also enjoys a position of complete primacy in the…

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Added by John Robinson on March 12, 2018 at 5:48am — No Comments

Deaths in Dundalk

Suddenly. Beloved husband of Katherine and dear father of Mary, John and Kevin. Jerry had a long and personally rewarding career as a dedicated nurse, taking him into contact with many who truly appreciated his care. He will be sadly missed by his loving wife, sons, daughter, son-in-law Alan, daughter-in-law Grace, grandchildren Molly, Emma, Séan and Āine, brother Tommy, sister Betty, sisters-in-law, brothers-in-law, nephews, nieces, relatives, nursing colleagues, patients and many friends.…

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Added by John Robinson on March 7, 2018 at 5:22am — No Comments

FDA inspection is not going to invite an FDA action such as a 483 or a Warning Letter

If there is one common cause for apprehension between the smallest and biggest, and the best known and least known organizations; it has to be an FDA inspection! Any organization that is subject to an FDA inspection has to get absolutely everything of everything about its activities right to a T, to such an extent that it should be sure simply all the time, through all its processes, that an…

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Added by John Robinson on March 1, 2018 at 6:16am — No Comments

Concerned about health and safety on the job?



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Added by John Robinson on February 20, 2018 at 4:55am — No Comments

Risk Management in the Global Economy and outlook for 2017



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Risk management in the global economy is a highly challenging field for risk managers from any part of the world. With most of the world’s countries almost…

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Added by John Robinson on February 19, 2018 at 4:34am — No Comments

An understanding of Risk Management and Analysis for Medical Device Manufacturers



Risk Management and Analysis1.jpg https://globalcompliancepaneltraining.files.wordpress.com/2018/02/risk-management-and-analysis1.jpg?w=914&h=620 914w,…

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Added by John Robinson on February 16, 2018 at 5:29am — No Comments

Benefits of Risk Management in all Industries 2018



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Added by John Robinson on February 15, 2018 at 4:35am — No Comments

Ways of managing risk in construction projects



Ways of managing risk in construction projects 1

The ways of managing risk in construction projects need to be drilled down into the systems that are used in construction projects. Managing risk in…

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Added by John Robinson on February 14, 2018 at 4:59am — No Comments

How is Risk Management Important to Project Success?



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The answer to how risk management is important to project success is best illustrated by the fact that no project has ever succeeded without proper risk…

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Added by John Robinson on February 13, 2018 at 5:06am — No Comments

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