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John Robinson's Blog (58)

Which universities are pushing the boundaries in life sciences?

If you had to name the branch of university research that has the most tangible impact on mankind’s day-to-day activities, it is likely that the life sciences would be near the top of the list: not many days go by without the announcement of a new drug or gene discovery that has the potential to change lives or tackle disease.

Much of the best research in these fields takes place in the ultra-elite universities that excel in subjects across the…

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Added by John Robinson on July 25, 2017 at 6:14am — No Comments

Implementing ICH guidelines-compliant validation

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Professionals in the field of statistical analysis need to possess clarity on understanding and interpreting statistical concepts used to investigate quantitative ICH Guidelines, such as:

  • Analytical methods validation
  • Procedures and acceptance criteria in calibration limits…
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Added by John Robinson on July 24, 2017 at 6:07am — No Comments

An integrated approach is needed for Complaints Handling, Adverse Event Reporting, and Recalls

Adverse Event Reporting, and Recalls4

The fact that medical device manufacturers work and operate in various regulatory systems whose requirements are different and not always consistent with each other is recognized and empathized by the…

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Added by John Robinson on July 21, 2017 at 5:56am — No Comments

Training and Development is a highly developed and evolved, broad body of knowledge. Many employees place themselves at a disadvantage vis-à-vis their colleagues in the absence of the right professio…

Development of technical training in the life sciences3

Training and Development is a highly developed and evolved, broad body of knowledge. Many employees place themselves at a disadvantage vis-à-vis their colleagues in the absence of the right professional training and development. If employees have to consistently close gaps in their learning, they need to keep…

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Added by John Robinson on July 19, 2017 at 6:21am — No Comments

The ways of applying ISO 14971, IEC 62304 and IEC62366-1 to medical device software

The ways of applying ISO 14971, IEC 62304 and IEC62366-1 to medical device software 3

Diligence, complete and proper examination and assessment of the gaps, and correction of the gaps right from the very start of product development are the core characteristics that need to go into implementing risk management of software used in medical devices.

These are the reasons for it:

  1. Lack of proper and complete implementation and gaps in them lead to major drawbacks such as production delays or…
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Added by John Robinson on July 13, 2017 at 6:47am — No Comments

Do human factors matter in medical devices?

Do human factors matter in medical devices1

Is there a relationship between medical devices and human factors? This is a question that is seriously worth exploring. According to the ANSI/AAMI HE75:2009 document, human factors is an endeavor for optimizing the production of devices, systems, and many others concerned with them through the use of emotional, intellectual,…

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Added by John Robinson on July 12, 2017 at 6:21am — No Comments

Knowing what to expect in a HIPAA audit is the key to passing it

Knowing what to expect in a HIPAA audit is the key to passing it Healthcare professionals have to mandatorily carry out HIPAA audits in a way that satisfies the regulatory authorities. This needs a thorough understanding of the exact meaning and import of words contained in HIPAA. They also need to get a grasp of the purpose and intent conveyed in HIPAA’s language. This is absolutely essential for both the…

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Added by John Robinson on July 7, 2017 at 6:09am — No Comments

Safety Management and OSHA Compliance

Safety Management and OSHA Compliance 1

Why is Occupational Safety and Health Administration (OSHA) compliance necessary? For a simple reason: OSHA compliance is the surest legal way of ensuring safety at the workplace. Safety management and OSHA compliance go hand in hand and are deeply connected to and intertwined with each…

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Added by John Robinson on June 28, 2017 at 6:15am — No Comments

Documenting Software for FDA Submissions

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The Agile methodology is an important tool for software project management. It emerged out of the gradual efforts at arriving at a team based methodology of iterative software development. Its close association with software makes it as suitable to this field as Lean is to manufacturing.…

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Added by John Robinson on June 27, 2017 at 6:15am — No Comments

All about biosimilars –from development to registration

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Biosimilars can be described as near-copies of an original pharmaceutical product that another company may have manufactured. These products are versions of an original or innovative product, but are officially approved.

There is a misconception that they are similar to or are the same as generics, but this is not so in…

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Added by John Robinson on June 27, 2017 at 6:01am — No Comments

HIPAA compliance expectations from Small Healthcare Providers

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Added by John Robinson on June 14, 2017 at 6:28am — 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 6:48am — No Comments

Writing and implementing effective SOP’s

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Added by John Robinson on June 6, 2017 at 6:36am — No Comments

Validation the complies with ICH guidelines



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Added by John Robinson on June 5, 2017 at 7:26am — No Comments

Four years of the EU’s Cosmetics Product Regulation

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Added by John Robinson on June 2, 2017 at 6:18am — 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 5:52am — No Comments

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