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John Robinson's Blog (62)

HIPAA compliance expectations from Small Healthcare Providers

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Added by John Robinson on June 14, 2017 at 6:27am — No Comments

Change Control is at the core of GMP Compliance

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Added by John Robinson on June 13, 2017 at 6:46am — No Comments

Quality by Design using Design of Experiments

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Added by John Robinson on June 8, 2017 at 6:47am — No Comments

Writing and implementing effective SOP’s

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Added by John Robinson on June 6, 2017 at 6:35am — No Comments

Validation the complies with ICH guidelines



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Added by John Robinson on June 5, 2017 at 7:24am — No Comments

Four years of the EU’s Cosmetics Product Regulation

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Added by John Robinson on June 2, 2017 at 6:17am — No Comments

Seminar Calendar of Upcoming Courses - June to July - 2017

 

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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Added by John Robinson on May 24, 2017 at 5:51am — No Comments

“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 specifications

o  Performing…

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Added by John Robinson on May 19, 2017 at 5:51am — No Comments

Knowledge of employment laws is absolutely crucial for organizations

As the new presidential administration settles in in the US, employment law…

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Added by John Robinson on May 17, 2017 at 5:56am — No Comments

Marketing and promotion of drugs and medical devices

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Added by John Robinson on May 16, 2017 at 6:22am — No Comments

Key issues in HR auditing

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Added by John Robinson on May 15, 2017 at 5:36am — No Comments

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…

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Added by John Robinson on May 11, 2017 at 8:23am — No Comments

Understanding the FDA’s GMP Expectations for Phase I and First-in-Man Clinical Trials

The establishment of the initial safety of a drug is the primary reason for which early clinical trials are conducted. Phase I of drug development consists of:

o  Research and drug…

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Added by John Robinson on May 9, 2017 at 6:04am — No Comments

Technical training in the life sciences

It is accepted that Training and Development is a highly developed area that bring its own body of knowledge. It uses a wide variety of techniques and approaches that are designed to meet the unique and complex challenges associated with training.…

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Added by John Robinson on May 8, 2017 at 7:57am — No Comments

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…

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Added by John Robinson on May 5, 2017 at 6:21am — No Comments

Validation in accordance with ICH guidelines

Chemical

Professionals in the field of statistical analysis need a clear and perceptive insight into how to understand and interpret statistical concepts used to investigate quantitative ICH Guidelines such as analytical methods validation, procedures and acceptance criteria in calibration limits. Along with these, process and quality controls, as well as ICH Q8 and Q9 also need to be properly and thoroughly understood.

The ICH tripartite-harmonized ICH…

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Added by John Robinson on May 3, 2017 at 6:18am — No Comments

The ingredients of a truly effective internal audit program

AFirst Slide n internal audit program of an organization’s Quality Management Systems is a core requirement from both the ISO and the FDA. At its barest, an internal audit system can be understood to be an assessment or inspection of an organization’s Quality System. Audits are a very beneficial and positive tool for continually ensuring that an organization’s internal management…

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Added by John Robinson on May 3, 2017 at 5:55am — No Comments

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Lawrence Behr added a discussion to the group RF Safety (Wireless & Industrial Risks)
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Lawrence Behr added a page to the group RF Safety (Wireless & Industrial Risks)
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Now, Get All Your RF Safety Equipment, Training and PPE In One Place

A first in RF compliance, we provide fast access to RF safety services, products, and technical support. With one click, you reach LBA’s wide resources for RF surveys, NIER audits, PPE, online safety training, certification and more - with the best…
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The Jacobson Group posted a blog post

10 Ways To Destress Your Employees (Infographic)

The Jacobson Group created the infographic below to showcase easy steps to help relieve stress for your employees during the work day. A more stress free environment can help build a relationship with your employees as well as a more efficient and productive workplace. Check out some of our tips below!10 ways to destress your employees infographic from…See More
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SQL Server Windows Management Instrumentation Tasks

Hello,SSIS includes two special tasks that enable you to query system information and monitor system events: the WMI Data Reader Task and the WMI Event Watcher Task. These tasks are especially useful…Continue

Tags: Task, WMI, Server, SQL

Started by Madison Quinn on Tuesday.

difference between NEBOSH and IOSH

NEBOSH “National Examination Board in Occupational Health and Safety”IOSH “Institution…Continue

Tags: kerala, IGC, NEBOSH

Started by mani May 31.

What's your favorite motivational/safety quote? 98 Replies

Favorite Motivational Quote: If you want something, you'll find a way - If not, you'll find an excuse.Favorite Safety Quote: Don't learn safety by accident!Continue

Started by Michelle Sears. Last reply by David R Snell Apr 26.

Feedback on a injury prevention product we're building.

Hi everyone!For full transparency ill tell you a little about myself and what I hope to accomplish. My name is Zuber and I'm an engineering student who founded a startup helping to build wearable…Continue

Tags: product, prevention, injury, back, safety

Started by Zuber Ahmed Apr 24.

Best overall personal safety book? 1 Reply

What do you think is  the best all-in-one book out there for optimizing personal safety and the safety of one's family?  Right now I have …Continue

Started by David R Snell. Last reply by David R Snell Apr 21.

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