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Corrective and Preventive Action (CAPA) is the foundation of a robust Quality Management System (QMS). Building a compliant, effective, and solid CAPA process into the QMS is the only way by which a company's QMS can guarantee safe and effective products.
A weak CAPA process invites disastrous consequences like complaints, recalls, 483s, and Warning Letters. It is a fact that CAPA is one of the most frequently cited reasons by the FDA for issuing 483’s and Warning Letters. Moreover, a…
ContinueAdded by Adam Fleming on February 7, 2020 at 5:54am — No Comments
Corrective and Preventive Action (CAPA) is the foundation of a robust Quality Management System (QMS). Building a compliant, effective, and solid CAPA process into the QMS is the only way by which a company's QMS can guarantee safe and effective products.
A weak CAPA process invites disastrous consequences like complaints, recalls, 483s, and Warning Letters. It is a fact that CAPA is one of the most frequently cited reasons by the FDA for issuing 483’s and Warning Letters. Moreover, a…
ContinueAdded by Adam Fleming on February 7, 2020 at 5:54am — No Comments
Corrective and Preventive Action (CAPA) is the foundation of a robust Quality Management System (QMS). Building a compliant, effective, and solid CAPA process into the QMS is the only way by which a company's QMS can guarantee safe and effective products.
A weak CAPA process invites disastrous consequences like complaints, recalls, 483s, and Warning Letters. It is a fact that CAPA is one of the most frequently cited reasons by the FDA for issuing 483’s and Warning Letters. Moreover, a…
ContinueAdded by Adam Fleming on February 7, 2020 at 5:54am — No Comments
The webinar begins with a discussion of relevant regulatory requirements, as motivation for calculating "confidence/reliability". Then, some vocabulary and basic concepts are discussed.
Next, detailed descriptions are given for how to calculate confidence/reliability for data that is either pass/fail (i.e., "attribute" data), normally-distributed measurement data, non-normally distributed measurement data that can be transformed into normality, or non-normally distributed measurement…
ContinueAdded by Adam Fleming on February 7, 2020 at 5:52am — No Comments
Consumer Safety is paramount in the food industry, which an industry that is heavily regulated by domestic and international authorities such as the FDA, EPA etc.
Failing to maintain consumer safety in the food industry, is extremely costly both in human life and / or suffering and in terms of the costs for recalls, fines levied against the company responsible for the lapse in safety, and impact to the reputation of the company, which can become irrevocable.
While consumer…
Added by Adam Fleming on February 7, 2020 at 5:51am — No Comments
Consumer Safety is paramount in the food industry, which an industry that is heavily regulated by domestic and international authorities such as the FDA, EPA etc.
Failing to maintain consumer safety in the food industry, is extremely costly both in human life and / or suffering and in terms of the costs for recalls, fines levied against the company responsible for the lapse in safety, and impact to the reputation of the company, which can become irrevocable.
While consumer…
Added by Adam Fleming on February 7, 2020 at 5:51am — No Comments
Consumer Safety is paramount in the food industry, which an industry that is heavily regulated by domestic and international authorities such as the FDA, EPA etc.
Failing to maintain consumer safety in the food industry, is extremely costly both in human life and / or suffering and in terms of the costs for recalls, fines levied against the company responsible for the lapse in safety, and impact to the reputation of the company, which can become irrevocable.
While consumer…
Added by Adam Fleming on February 7, 2020 at 5:51am — No Comments
Surely, no pharma company can overlook the world’s second largest pharmaceutical market: China. Its huge population has a high demand for healthcare products. In tune with this growing requirement, many changes have been brought in into the healthcare system, which is now more attractive than ever to foreign companies that want to bring in new products to market.
On the one hand, factors such as incentives, such as market…
Added by Adam Fleming on October 9, 2019 at 7:29am — No Comments
Focus on how to avoid the pitfalls that may occur during FDA inspections and help eliminate 483 observations. Learn how to identify and avoid potential pitfalls during deviation investigations.
One of the foremost common authority 483 and Warning Letter citations continues to be inadequate investigations. The authority uses the investigation reports and investigation trends to spot potential quality issues altogether areas…
Added by Adam Fleming on August 12, 2019 at 8:35am — No Comments
A few sciences are changing our lives in more ways than we could have imagined a few decades ago. Artificial Intelligence (AI) is at the forefront of these. Although a few decades old, it has received a huge boost of late with the emergence of the cloud, which is set to help it overcome one of its biggest stumbling blocks, namely space, the added power of computing, and wider methods of algorithms.
While one would like to…
Added by Adam Fleming on May 16, 2019 at 7:05am — No Comments
Nothing perhaps rattles a regulatory professional as much as an FDA inspection! It can send the regulatory professional who is in charge of compliance into panic mode for a variety of reasons. As the one who faces the heat from the FDA directly, the regulatory professional is answerable to the FDA, most of whose questions are challenging and awkward. If anything goes wrong at any stage, it is the company that suffers.
Yet,…
Added by Adam Fleming on March 11, 2019 at 8:57am — No Comments
Near-Infrared Spectroscopy, NIR or NIRS, is considered a superior method assay to traditional ones, which are destructive and also reduce the number of doses for sale. It overcomes these drawbacks by being both rapid and nondestructive, which helps it respond to the pressures in the pharma industry for generating more and more data, which leads to more assays that bring these inevitable…
Added by Adam Fleming on February 21, 2019 at 7:40am — No Comments
The Final Rule for Clinical Trials Registration and Results Information Submission (42 CFR Part 11) clarifies and expands the regulatory requirements and procedures for submitting registration and results information for certain clinical trials to ClinicalTrials.gov, in accordance with Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801).
The Final Rule has been in effect since January 18, 2017. The…
Added by Adam Fleming on February 18, 2019 at 6:22am — No Comments
Compliance4All, a leading provider of professional training for all the areas of regulatory compliance, is organizing a webinar on the topic, “Complaint Handling” on February 6. Peggy J. Berry, President & CEO at Synergy Consulting, will be the speaker at this webinar.
Please visit http://bit.ly/2GFGiXr to enroll for this webinar.
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A complaint says a lot about a product. It helps the…
ContinueAdded by Adam Fleming on February 15, 2019 at 6:54am — No Comments
Compliance4All, a leading provider of professional training for all areas of regulatory compliance, is organizing a 90-minute webinar on the topic, “Dietary Supplements CGMPS – 21 CFR 111 Compliance”, on February 5. John E. Lincoln, a medical device and Regulatory Affairs consultant, will be the expert at this webinar.
Please visit http://bit.ly/2DIk8lf to enroll for this webinar.
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How to find the…
ContinueAdded by Adam Fleming on January 30, 2019 at 7:07am — No Comments
If you work with data, you’re likely already familiar with common frustrations with Microsoft Excel like size limitations and manually entering data from multiple sources. Luckily there are two Microsoft tools- PowerPivot and PowerQuery-that solve ALL of these issues, right inside Excel.
In today’s world, there is tons of data to manage. Data is coming from many different sources. It is very important to be able to process that data quickly and then summarize it into meaningful…
ContinueAdded by Adam Fleming on December 5, 2018 at 7:05am — No Comments
Let us face it. A cyber incident could happen to any organization that has a computer system that is connected to the Net. Well, the next question is, does such an organization exist? Almost no organization in today’s world, no matter of what size and which part of the world it could be in, can function without a cyber system. So, this means that simply any organization is vulnerable to a cyberattack and every organization should have a cyber…
ContinueAdded by Adam Fleming on November 16, 2018 at 7:02am — No Comments
The Food and Drug Administration (FDA) is the US’ regulatory agency for a variety of products that concern the health of their consumers. The FDA regulates everything concerning food, medicine, medical devices, veterinary products and cosmetics, as well as products that emit radiation. In addition to directly regulating all these through its set of regulations, the FDA also encourages innovation in the products and processes of products in these…
Added by Adam Fleming on November 2, 2018 at 6:30am — No Comments
A medical device inspection. Ah! Is there a more dreaded exercise for a medical device manufacturer? If I were given a choice between taking up the world’s toughest rated examination and facing a medical device inspection, I would gladly opt for the former. A medical device inspection should rank right there ahead of the most difficult examination or task.
Alright. We knew this fact all along. So, why should I intimidate you by casting such aspersions on a medical device inspection?…
ContinueAdded by Adam Fleming on October 30, 2018 at 6:29am — No Comments
Trade and logistics, despite its relatively recent development, has gone on to become a global one. It is one of the many industries that have benefited in immeasurable ways by the growth of technology and globalization. It is no exaggeration to say that trade and logistics has exploded following these developments.
First, a basic understanding of the two:…
ContinueAdded by Adam Fleming on October 15, 2018 at 6:04am — No Comments
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