Some of the biggest names of India’s hospitality industry descended at the Hyatt Regency Hotel Gurgaon on Wednesday evening to celebrate the fourth season of ‘The Big F Awards’ – undoubtedly, Gurgaon’s biggest & most popular food awards.
The gala event was marked with the presence of bigwigs from the food & beverage…
Added by Adam Fleming on September 22, 2017 at 5:55am — No Comments
TRENTON, N.J. (AP) — The Food and Drug Administration issued new warnings Wednesday about the dangers of combining medication for opioid addiction with anti-anxiety medicines and other drugs that also slow breathing and brain activity.
The FDA warned that mixing such drugs can cause difficulty breathing, coma or death, so it should be done with caution.
The agency said…
Added by Adam Fleming on September 21, 2017 at 6:03am — No Comments
In late 2016, the FDA published the revised the Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients, Guidance for Industry. The aim of this revision is to address Good Manufacturing Practices (GMPs) for a Quality Management System for Active Pharmaceutical Ingredients (API’s). Another of its aims is to help companies ensure that they meet the requirements of API quality and purity characteristics. While replacing Q7A Good Manufacturing Practice…
Added by Adam Fleming on September 20, 2017 at 6:27am — No Comments
About Nitinol-based Medical Devices
Nitinol-based medical devices are made of nitinol, an alloy of nickel and titanium. The use of nitinol-based stents and guidewires has improved procedural outcome. The nitinol alloys are corrosion resistant and are highly accepted in the medical device industry. The global medical devices market has been growing extensively over the years. With increasing investment in research and development (R&D) for manufacturing…Continue
Added by Adam Fleming on September 19, 2017 at 6:04am — No Comments
Some of the functions of medical device manufacturers include:
o Analyzing complaints
o Processing data
o Evaluating nonconformances
o Utilizing other quality data sources.
The main purpose of this analysis, done using appropriate statistical methodology, under §820.100, is to identify the cause of nonconforming products and other quality problems. Time series analysis is one such family of these tools. Also called trending analysis,…
Added by Adam Fleming on September 18, 2017 at 6:49am — No Comments
The core of successful operation by a drug maker is laboratory testing. current Good Manufacturing Practices (cGMP) regulations require a drug manufacturer to use laboratory testing as a tool to validate that everything that goes into a laboratory product, such as in-process materials, finished materials, and containers adhere to set specifications. When all these are done, a major challenge for laboratories is in how to deal with a test that shows an…
Added by Adam Fleming on September 12, 2017 at 5:58am — No Comments
Bloodborne pathogens are those microorganisms present in the human blood that carry infection. These infections can cause disease in humans. The major bloodborne pathogens that cause infections in humans are:
o Hepatitis B (HBV)
o Hepatitis C (HCV)
o Human immunodeficiency virus (HIV)
Although these are the main disease causing pathogens; there are many more. So, hospital staffs who deal with patients who are infected by…
Added by Adam Fleming on September 8, 2017 at 5:45am — No Comments
Form FDA 1572 is one of the primary documents needed when carrying out a clinical trial. Also called the Statement of Investigator; Form FDA 1572, called just 1572 informally, is a contract between the Principal Investigator (PI) and the FDA. This form contains all details of the subjects, as well as commitments from the PI.
It is a contract in which the Principal Investigator, the person who is…Continue
Added by Adam Fleming on September 6, 2017 at 6:11am — No Comments
An internal audit, as we all know, is carried out for a number of specific purposes, the main one among which is to assess the adherence to the industry guidelines for quality and processes. Helping the organization meet the requirements of processes and standards, which are usually issued by regulatory agencies and other relevant bodies and boards, is the main aim…Continue
Added by Adam Fleming on September 4, 2017 at 5:36am — No Comments
Of late, the FDA has been turning on the heat on manufacturers in the FDA-regulated industries that violate its regulations. It has a penchant for going after manufacturing facilities that show laxity in implementing current Good Manufacturing Practices (cGMP). This ardor is understandable. cGMP violations affect the quality of the product; hence the strictness, considering that it is patients who consume these products.
There are ways of ensuring that the product…Continue
Added by Adam Fleming on September 1, 2017 at 6:05am — No Comments
Auditing is a very important aspect of quality in all the areas of the medical sciences. An audit is the most reliable and foolproof method for evaluating the extent to which the various activities in an organization comply with the requirements and expectations the principal has from those to whom various processes are outsourced. Audits are the main tools for a quality unit to monitor and ensure that those activities are performed in compliance with the manufacturer commitments for quality…Continue
Added by Adam Fleming on August 29, 2017 at 5:26am — No Comments
Corporate revenue account fraud and account manipulation are serious issues for businesses in many parts of the world today. Although legislations such as Sarbanes Oxley have been passed with the intention of making corporates more accountable; corporate accounting is still vulnerable to manipulation and fraud. A company’s financial statement is a primary area in which a fraud can happen.
A financial statement is the elementary piece of documentation which reflects a…Continue
Added by Adam Fleming on August 22, 2017 at 5:28am — No Comments
The General Data Protection Regulation (GDPR), which has been codified as Regulation (EU) 2016/679, is a very powerful law regarding the protection of data of the half billion people who live in the European Union (EU). Having come into effect as a result of the European Commission having adapted the proposal for its creation on January 25, 2012; it will replace Directive…Continue
Added by Adam Fleming on August 16, 2017 at 5:31am — No Comments
The FDA’s regulations on cleanroom environmental monitoring (EM) are based on the assumption that any person who enters a cleanroom is likely and almost certain to have brought contaminants in one or another form with him. The FDA’s regulations on cleanroom environmental monitoring are built on the thinking that microorganisms can assail even the cleanest of systems, which is why its regulations on cleanroom…Continue
Added by Adam Fleming on August 9, 2017 at 5:39am — No Comments
Quality controls in laboratories are a major area for which the FDA issues 483’s. A laboratory is the venue for many activities, all of them of varying importance to the product. When controls in laboratories are not up to the standard, such a laboratory could produce products that do not meet quality and processes expectations, and hence invite 483’s.
Issues with drug quality, drug integrity and data integrity, as well as data fabrication and human errors…Continue
Added by Adam Fleming on August 8, 2017 at 5:35am — No Comments
To say that the manufacturing industry is huge is to make a huge understatement. It is an activity that spans entire industries and is the lifeblood of many economies, right from advanced to developing ones. Despite the advancement in automation in the processes of many industries, manufacturing is still heavily dependent on human labor.
This makes manufacturing an activity that is prone to human error, because wherever there is human involvement, there is scope for human error. Why…Continue
Added by Adam Fleming on August 7, 2017 at 5:40am — No Comments
The Hazard Analysis and Critical Control Point (HACCP) is a process control system that is aimed at identifying the points or areas at which hazards (dangers) may arise in the food chain. It prescribes strict measures for manufacturers and transporters of food products to prevent contamination and the resultant hazards. Control of hazards in the food chain has always been a need, but HACCP assumes added significance in today’s…Continue
Added by Adam Fleming on August 4, 2017 at 5:31am — No Comments
In any industry, compliance is everything; be it highly specialized fields such as the life sciences, healthcare, medical devices or non-technological areas such as food and clothing. Why do companies need to be compliant? It is simply because being in compliance with the required regulatory requirements helps the organization to achieve the most positive outcomes needed for a business:
Added by Adam Fleming on August 3, 2017 at 5:48am — No Comments
Mastering MS Excel formulas and functions can make a miracle out of this program. When used optimally, MS Excel can be a wonderful tool for carrying out umpteen functions and optimizing work related to a number of departments. For example, the Accounts Department can do a number of important functions such as loan repayment calculation, generating a profit and loss statement, solve complex mathematical and engineering problems, and carry out anything that involves addition, subtraction,…Continue
Added by Adam Fleming on August 2, 2017 at 5:35am — No Comments
Hazard Analysis and Critical Control Point (HACCP) is an important system aimed at bringing down the risk of safety hazards found in food consumed all over the world. It is an internationally recognized system. When it was enacted in January 2011 as part of the FDA’s Food Safety Modernization Act; it was considered a very sweeping piece of legislation for the food industry.
Identification and control of…Continue
Added by Adam Fleming on August 1, 2017 at 5:38am — No Comments