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 —
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 —
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.
Added by Adam Fleming on March 11, 2019 at 8:57am —
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 8:40am —
Compliance4All, a leading provider of professional training for all the areas of regulatory compliance, is organizing a webinar on the topic, “Onboarding Employees in a GMP Environment: Best Practices for Foundational Employee Success” on February 6. Michael Esposito, a senior professional with rich experience in the pharmaceutical industry, GMP training and document management, will be the speaker at this webinar.
Please enroll for this webinar by visiting… Continue
Added by Adam Fleming on February 19, 2019 at 8:08am —
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 7:22am —
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.
A complaint says a lot about a product. It helps the… Continue
Added by Adam Fleming on February 15, 2019 at 7:54am —
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.
How to find the… Continue
Added by Adam Fleming on January 30, 2019 at 8:07am —
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… Continue
Added by Adam Fleming on December 5, 2018 at 8:05am —
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… Continue
Added by Adam Fleming on November 16, 2018 at 8:02am —
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 —
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?… Continue
Added by Adam Fleming on October 30, 2018 at 6:29am —
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:… Continue
Added by Adam Fleming on October 15, 2018 at 6:04am —
Microsoft Excel is a wonder package, and in saying this, I am not exaggerating or taking sides with Mr. Gates’s developers. They have created a program that is so versatile and so tailor-made for just so many industries that you would wonder from where they got the idea to do this. I reckon they must have worked extensively with the industry closely in understanding its needs and implemented all the details with devilish diligence.… Continue
Added by Adam Fleming on October 10, 2018 at 3:13am —
Wondering if you should attend clinical compliance trainings? The following paragraphs will explain to you the criticality of clinical compliance trainings. We hope this article will help you understand why you should attend clinical compliance trainings.
First, let us… Continue
Added by Adam Fleming on October 8, 2018 at 5:46am —
Formally known as the “Public Company Accounting Reform and Investor Protection Act” in the US Senate and as the “Corporate and Auditing Accountability and Responsibility Act” in the House of Representatives, Sarbanes Oxley (SOX) is a landmark legislation that the American Congress passed in 2002. Named for the sponsors of this Bill, senators Paul Sarbanes and Mike Oxley, it was passed in the wake of the financial scandals of huge American… Continue
Added by Adam Fleming on October 5, 2018 at 3:18am —
The food and beverages industry, a global one, is an interesting bag of surprising and often contradicting facts. The food and beverages industry is a really global one, meaning there is almost no place on this planet that this industry does not cover. You are as likely to find a food joint in Mongolia as you are in Mozambique. The reason is simple: we can live without many things, but not without food. Any surprise that this industry is a giant,… Continue
Added by Adam Fleming on October 1, 2018 at 5:39am —
Trainings are a necessary ingredient for excellence in organizations. On-the-job training is almost a must for most employees at various levels in organizations. Trainings are necessary for a variety of reasons. Many employees who are just out of college may sometimes feel the need to get trained to help them understand the organization and the job better because the actual work the organization does may not be part of the curriculum they may…
Added by Adam Fleming on September 24, 2018 at 5:41am —
Like any other industry, the food and beverage industry too, is unique in its own way, carrying its own set of characteristics. It is a curious mix of the big and the small, not only in terms of the size of companies in it, but also the reach of these companies.
In a sense, the food and beverage industry is…
Added by Adam Fleming on September 19, 2018 at 6:27am —
What makes risk management critical? Well, business that comes with no risk is no business at all. It is like the side effect of a medicine. It is impossible to think of the medication without the side effects. Risk being inhered into a business and intricately woven into it; it is necessary to understand why you must keep carrying out risk management throughout your business’ lifetime. This places risk management right up there at the very top… Continue
Added by Adam Fleming on September 17, 2018 at 7:49am —