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All Blog Posts (1,003)

How does the FDA scrutinize Promotion and Advertising Practices?

The FDA has strict requirements on the way promotion and advertising practices are to be implemented by the industries that it regulates. Section 906 of the Food and Drug Administration Amendments Act (FDAAA), which came into effect in 2008 and amended the section that pertained to this topic previously, namely Section 502(n) of the Federal Food, Drug, and Cosmetic Act (FDCA); now requires that published Direct to Consumer (DTC) advertisements for prescription drugs should…

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Added by Compliance4all on May 11, 2017 at 6:23am — No Comments

Thorough understanding of the CERT program is necessary to fix error rates

The Comprehensive Error Rate Testing (CERT) is a program used by the Centers for Medicare & Medicaid Services (CMS) for calculating the rate or extent of improper payments of Medicare Fee-for-Service (FFS). The method used by the CMS under CERT is to pick up a stratified random sample of some 40,000 claims that are statistically valid and calculate and audit it to determine if the payments were made in accordance with the rules relevant to items such as coding, Medicare coverage, and…

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Added by Roger Steven on May 10, 2017 at 8:45am — No Comments

Overcoming the pain of HIPAA enforcement

In many years that it has been in existence, one of the noticeable changes that HIPAA has undergone is in its attitude. The earlier phase of advice and counseling has now given way to hardboiled and unforgiving enforcement. The Office of Civil Rights (OCR) no longer uses the cajoling and persuasive method. It wants to impose super harsh penalties on healthcare organizations which violate its rules.

For starters, healthcare organizations have to reckon with new, ominously higher fines,…

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Added by Roger Steven on May 10, 2017 at 8:43am — No Comments

How to implement technology transfer in pharmaceuticals

Technology transfer is a process that has gained widespread acceptance and prominence in many areas of knowledge all over the world today. Technology transfer can be broadly defined as the way in which technology is transferred from the source of its origin of creation to sources from where it can be developed and/or distributed to a wider area.

Technology transfer is carried out in a number of…

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Added by Compliance4all on May 10, 2017 at 6:41am — No Comments

Understanding cash management in ERP systems and setting up and reconciling bank statements

Cash management is a major component in ERP systems such as Oracle. It is a module that offers information about the most critical component of the business, namely cash flow. Cash management processes and analyzes all of the business’ cash and bank transactions from a number of sources such as:…

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Added by Compliance4all on May 9, 2017 at 6:19am — 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

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

All about human error and ways of reducing it

There is the saying that after all is said and done, to err is human. In a philosophical sense, it can have numerous interpretations, but in the field of Good Manufacturing Practice, it cannot be taken with a pinch of fatalism. GMP requires everything to be precise and scientific to a T. GMP is not an area that leaves anything to human error. Being an area of science, GMP has no place for imagination and chance.…

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Added by Compliance4all on May 8, 2017 at 7:48am — No Comments

Understanding the FDA’s thinking behind 21 CFR Part 11 inspections

21 CFR Part 11 is an FDA regulation that deals with electronic records and electronic signatures. 21 CFR Part 11 has a set of FDA regulations that define the various parameters that need to go into electronic records and electronic signatures for them to be considered genuine, that is, for these records to have the same trustworthiness, reliability and equivalency as those of paper records.

Any organization has to comply with the requirements set out in…

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Added by Compliance4all on May 5, 2017 at 6:45am — 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

Learn how to future-proof VLOOKUP by using Excel’s Table feature versus referencing static ranges

Professionals in a wide number of industries and businesses find the VLOOKUP function in Excel very useful. Why this is so is that it helps in locating an exact value. Using VLOOKUP, an MS Excel user can find a specific piece of information in the spreadsheet. This is very useful when there are very many values in a grid. In other words, the VLOOKUP…

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Added by Compliance4all on May 4, 2017 at 6:14am — No Comments

Proper handling of Out of Specification (OOS) result is the hallmark of a robust investigation

The whole exercise of drug making is incomplete and unthinkable without laboratory testing. There is no better indicator of success on the part of the drug manufacturer than this activity. This is absolutely essential as a means for confirming that all the ingredients that make a laboratory product, such as the raw materials used in it, the in-process materials as well as the finished materials that go into it, and containers as well, all kowtow to the set, required…

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Added by Compliance4all on May 3, 2017 at 6:23am — 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

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…

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

The art of writing effective audit observations

Audits are a means of evaluating operations and other functions of an organization. ISO 19011:2011 Guidelines for Auditing Management Systems describes audits as a process used for gathering the evidence of verifiable documents and map their suitability, alignment and fulfilment with the company’s policies and procedures.

An audit is an important tool that helps organizations to analyze opportunities, implement best practices, and assess all the important factors in…

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Added by Compliance4all on April 27, 2017 at 6:29am — No Comments

Article on “A Tour of the FDA”

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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…

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

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