Online Safety Community

John Robinson's Blog (53)

“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…

Continue

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…

Continue

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

Marketing and promotion of drugs and medical devices

Continue

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

Key issues in HR auditing

Continue

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…

Continue

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…

Continue

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.…

Continue

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…

Continue

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…

Continue

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…

Continue

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

FDA requirements on data integrity and its implementation

The phrase “data integrity” seems to be everywhere. It is used in a number of places and situations, and the FDA has its own definition of the term. At its plainest, data integrity is defined as the assurance that data is complete, consistent and accurate. FDA requires this data to be…

Continue

Added by John Robinson on May 3, 2017 at 5:29am — No Comments

Article on “A Tour of the FDA”

Continue

Added by John Robinson on April 27, 2017 at 5:50am — No Comments

Good Manufacturing Practices are essential for ensuring quality

Key Takeaway:

GMPs are critical for the manufacture and distribution of foods, drugs and other pharmaceutical products. These need to be implemented diligently by organizations that are involved in these products.

Quality is a great concern for a manufacturer and consumer of any product. To ensure that quality is maintained across a variety of products ranging from foods to pharmaceutical products; a few guidelines are required. These guidelines…

Continue

Added by John Robinson on April 26, 2017 at 8:06am — No Comments

Article on “Statistical Sampling Plans for Medical Devices”

Continue

Added by John Robinson on April 21, 2017 at 6:04am — No Comments

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

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…

Continue

Added by John Robinson on April 20, 2017 at 7:20am — No Comments

Rising in one’s career through leadership management

Continue

Added by John Robinson on April 19, 2017 at 5:09am — No Comments

FDA and EU requirements on data integrity and implementation

Continue

Added by John Robinson on April 17, 2017 at 5:49am — No Comments

Applied Statistics for FDA Process Validation 2017

Continue

Added by John Robinson on April 12, 2017 at 5:29am — No Comments

Take our poll!

Take our poll!

Latest Activity

Nicole J Gomez posted a blog post

Answers to 5 FAQs Related to Establishing a Drug-Free Workplace

It is not uncommon for workplaces to deal with employees using illicit substances. Employee substance abuse is a problem that is beyond the abuser. Drug and alcohol abuse can easily lead to workplace accidents caused by negligence.Research conducted by the National Council on…See More
3 hours ago
Roger Steven posted a blog post

MentorHealth Webinar Calendar of Upcoming Courses

MentorHealth webinars are designed to offer professionals in the healthcare industry the knowledge they need in all the areas of the healthcare industry that enables them to excel in their professions. MentorHealth’s trainings bring experts from all the core areas of healthcare and impart learning to help professionals understand and implement all the important issues that matter to their professions. To keep updating your knowledge of regulatory compliance in the healthcare industry, all that…See More
20 hours ago
Profile IconShannon Case, Billy, Jane Otterson and 4 more joined Online Safety Community
21 hours ago
kate smith posted a blog post

The importance of onboarding

The importance of onboarding can be understood from the fact that it starts with the induction of the new hires and acclimatizes them with all the important aspects of the new organization, such as the culture, environment, people, and the business. In the light of the important elements that go into onboarding; it is a fallacy and a misconception to assume that it is yet another ritual that HR has to perform with new employees, hand them a cup of coffee and carry out the paperwork.Onboarding…See More
22 hours ago

Forum

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.

Fire codes for residential buildings

Hi,Can anybody kindly give me a hint how to find Fire Codes for residential buildings in different cities in the United States?Continue

Started by Darren Asad Apr 14.

OSHA and Machine Guard Door Safety???

We have what we feel is not a unique situation and were wondering if anyone might of run across this challenge and know more about the requirements.  We are building a small machine system that…Continue

Tags: electric, osha, air, door, interlocked

Started by Scott V Mar 24.

Badge

Loading…

© 2017   Created by Safety Community.   Powered by

Badges  |  Report an Issue  |  Terms of Service