Audits -both internal and external -are a vital tool for ensuring that a medical device or biotechnology product and its manufacturing operations meet prescribed regulatory requirements. Medical device and biotechnology auditors have guidelines on how to establish that the manufacturer has met standards such as ISO 13485, ISO 14971, or regulations such as 21 CFR Part 820.Apart from going by these guidelines; the auditor also uses her intuition and observation gained from personal experiences to ensure that the facility she has visited is putting in place the right mechanisms to ensure what a state of control looks like. Given that a medical device audit can happen at just about any time; it is imperative for an organization in the medical device industry to be prepared for an audit any time, all the time.What are the points that the manufacturer has to bear in mind to ensure compliance, so that the medical device audit goes on smoothly without events? What processes and methods should…See More

A recent admission by The U.S. Department of Agriculture’s Office of the Inspector General of its failure to review required documents for products labeled as “organic” indicates a lack of controls at U.S. borders, increasing the likelihood of nonorganic products entering the U.S. under false “organic” labels.This opens the floodgates for the entry of dubious products into the market and getting passed off as organic, without being that. In fact, many imported products that carry the organic label are not only completely non-organic; they contain GMO and pesticides.There is no guarantee that those who consume what are labeled as organic food are consuming food that is free of adulteration by pesticides, cross contaminants, and other hazards. This, despite the establishment in 2002 of the National Organic Program (NOP) standards, which prohibit the use of sewage sludge, GMO, ionizing radiation, synthetic pesticides, synthetic fertilizers, antibiotics, growth hormones, artificial…See More