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…
Added by Adam Fleaming on May 5, 2017 at 6:45am — No Comments
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
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…
Added by Adam Fleaming on May 4, 2017 at 6:14am — No Comments
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…
Added by Adam Fleaming on May 3, 2017 at 6:23am — No Comments
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
A 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
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
The health and safety sector and the green sector now thankfully meet with a selection of products that are effective in preventing harm to workers, while also benefitting the environment. Such developments are important factors in the modern workplace, which wants to keep employees safe and now also…Continue
Added by Alex on April 28, 2017 at 7:00am — No Comments
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…
Added by Adam Fleaming on April 27, 2017 at 6:29am — No Comments
Added by John Robinson on April 27, 2017 at 5:50am — No Comments
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…
Added by John Robinson on April 26, 2017 at 8:06am — No Comments
Added by John Robinson on April 25, 2017 at 6:17am — No Comments
Added by John Robinson on April 21, 2017 at 6:04am — No Comments
Shrink investigation is essentially about examining the causes of shrink (loss) in retail businesses. Although retail is one of the fastest growing areas of business, the possibility of shrink is very high in this area. It is also an overlooked area, because of which many shrinks that could otherwise have been prevented, do not get prevented.
Controlling losses is as important…
Added by Adam Fleaming on April 21, 2017 at 6:02am — No Comments
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
In the area of GMP regulations, procedures are very vital, for both execution and audits. It is always true that the greater the clarity and comprehensiveness with which these procedures are written; the easier it becomes for users to use them without missing important information for regulators.
Despite the advent of technology into almost all the areas of GMP regulations; there is still the existence of the human factor. It is still the major…
Added by Adam Fleaming on April 19, 2017 at 6:43am — No Comments
Added by John Robinson on April 19, 2017 at 5:09am — No Comments
Packaging and labeling of commercial and clinical products are very important aspects to an organization involved in a business that relates to these products. While the packaging and labeling of commercial products is important, it is more so with clinical products, because these products play an important role in a clinical trial and also in the very life of a patient or subject.
Commercial products have their own value over time. The FDA has guidances for…
Added by Adam Fleaming on April 17, 2017 at 8:41am — No Comments
Added by John Robinson on April 17, 2017 at 5:49am — No Comments
The FDA considers verification and transfer of Test Methods a subject worthy of 483 observations and issuance of Warning Letters. Test method verification is also required by the GMPs, and USP has a whole chapter dedicated to test method verification. This makes comprehension of the requirements for the verification and transfer of a test method into a laboratory imperative for Laboratory Managers and other personnel.…
Added by Adam Fleaming on April 12, 2017 at 6:42am — No Comments