MedTech I.Q.

The Cutting Edge of Medical Technology Content, Community & Collaboration

John Robinson's Blog (41)

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…

Continue

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…

Continue

Added by John Robinson on May 19, 2017 at 5:52am — 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 5:57am — 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 5:30am — 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

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

© 2017   Created by CC-Conrad Clyburn-MedForeSight.   Powered by

Badges  |  Report an Issue  |  Terms of Service