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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 Compliance4all 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
Advertising is a highly challenging and creative field. However, when making claims about the efficacy and effectiveness of products, especially drug products, advertising professionals need to comply with strict compliance guidelines which set out the limits of claims. The US government lays considerable stress on the veracity aspects of the advertising claims.
An ad for a drug product must state not just the benefits of a product, but also its side effects, risk…
Added by Compliance4all on April 25, 2017 at 6:22am — No Comments
Added by John Robinson on April 25, 2017 at 6:18am — 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 Compliance4all on April 21, 2017 at 6:03am — No Comments
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By attending, you will take advantage of a great opportunity to advance as a manager to the next level!
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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 Compliance4all on April 19, 2017 at 6:44am — 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 Compliance4all on April 17, 2017 at 8:42am — 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 Compliance4all on April 12, 2017 at 6:43am — No Comments
Added by John Robinson on April 12, 2017 at 5:30am — No Comments
In this interconnected, interdependent global world, the need for contracting procurement of any goods or services is strong and indispensable. However, the benefits of this feature notwithstanding, there are several loopholes in the procurement and contracting activity. Outsourcing and contracting, by their very nature, are vulnerable to fraud. Fraud can happen at any stage of the procurement and contract process.…
Added by Compliance4all on April 6, 2017 at 6:00am — No Comments
Regulatory agencies such as the FDA conduct inspections for product-related Good Manufacturing Practice (GMP) in the course of assessing an application for marketing approval. The basic purpose of product-related GMP inspections is to check for compliance with the GMP guidelines set out in the International Conference on Harmonization (ICH) and national and local GMP regulations. GMP is the slightest standard that a manufacturer has to mandatorily meet in its production…
Added by Compliance4all on April 3, 2017 at 6:29am — No Comments
Regulatory agencies the world over have put in place stringent requirements for ensuring that cleaning validation procedures for analytical equipment are effective. Even if putting these practices in place involves expense and effort, it is worth the trouble, because the cost of noncompliance is much, much higher than that of compliance.
Noncompliance with regulations for cleaning validation procedures for analytical equipment has a serious consequence: Regulatory…
Added by Compliance4all on March 30, 2017 at 6:43am — No Comments
Establishing Quality Systems is one of the central aspects of a medical device and/or pharmaceutical organization. Establishment of Quality Systems is also a regulatory requirement, as set out by the FDA and the ISO.
The process of establishment of Quality Systems for FDA-regulated medical devices industries is set out in 21 CFR Part 820. Further, the ISO has its standard for how to establish Quality Systems in medical devices industries –the ISO 13485 standard…
Added by Compliance4all on March 28, 2017 at 9:06am — No Comments
Medical device hazard analysis is of vital importance to a medical device. Medical device hazard analysis is at the heart of medical devices because if the device is not analyzed thoroughly for the hazard, or danger, that it poses, it is likely to cause problems of any kind to the user. Many a time, it becomes a matter of life and death. This is why medical device hazard analysis is of foremost importance.…
Added by Compliance4all on March 27, 2017 at 8:31am — No Comments
Quality and compliance are vital issues for any medical devices company. Despite the fact that the FDA’s regulatory compliance requirements are the same across the industry; many medical device companies are shocked when they receive a 483, or a Warning Letter, or even a consent decree. Is meeting the FDA’s regulatory requirements something of a chance, which some organizations get by fluke and others don’t?…
Added by Compliance4all on March 24, 2017 at 6:31am — No Comments