The Cutting Edge of Medical Technology Content, Community & Collaboration
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
In today’s globalized world, competition has increased multifold for most businesses. As globalization brings it with both opportunities and challenges, the marketplace has evolved to a point where it is imperative for companies to become global. This is an opportunity they can ignore at their own peril. International sales should become an essential part of an organization’s business plan.
The cost advantages that accrue from producing overseas, the revenue opportunities from foreign…
ContinueAdded by Joseph Wilcox on March 29, 2019 at 7:16am — No Comments
The successful launch of pharmaceutical products and their processes is directly related to the success of another factor: their transfer. It is only through successful transfer of these processes that the pharmaceutical company can ensure that its products are not only of the highest quality, but also get delivered to the patients and meet the business demands of the company. Expectedly, the execution of this transfer is not very simple and straightforward. It involves the interactions and…
ContinueAdded by Joseph Wilcox on March 27, 2019 at 7:09am — No Comments
Technically, all FDA inspections include a Standard Operating Procedures (SOPs) review. Deficiencies in the SOP constitute a large number of the FDA's inspectional observations of organizations. The reason for this occurrence is that although SOPs are required for companies in the regulated industries, there are no clear-cut guidelines laid out by the regulatory bodies on the ways of writing, maintaining, and updating SOPs.
In the absence of these guidelines, many organizations end up…
ContinueAdded by Joseph Wilcox on March 14, 2019 at 8:21am — No Comments
Technically, all FDA inspections include a Standard Operating Procedures (SOPs) review. Deficiencies in the SOP constitute a large number of the FDA's inspectional observations of organizations. The reason for this occurrence is that although SOPs are required for companies in the regulated industries, there are no clear-cut guidelines laid out by the regulatory bodies on the ways of writing, maintaining, and updating SOPs.
In the absence of these guidelines, many organizations end up…
ContinueAdded by Joseph Wilcox on March 12, 2019 at 8:44am — 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
If you have a colleague who gets down to hairsplitting detail at every work she undertakes, to the extent that she takes half a day to complete a task that can be done in half an hour, you have a person with OCD in your midst. Obsessive Compulsive Disorder is a psychological condition in which the person with it is too obsessed with perfection. This penchant for perfection in everything they do can be painstaking for others who interact with them, but for those with…
ContinueAdded by Joseph Wilcox on March 7, 2019 at 6:54am — No Comments
Fortune 500 companies and small family businesses alike share a business need - insuring that they have the talent necessary to effectively lead their organizations in the future. One of the most significant contributions a leader can make is insuring his/her business'continuity and sustainability - by having employees who are willing and capable of filling each key position with a plan for doing so when the need arises.
Succession Planning is a:
Added by Joseph Wilcox on March 5, 2019 at 7:00am — No Comments
Traininng.com, a leading provider of professional training for all the areas of regulatory compliance, is organizing a 60-minute webinar on the topic, “Why & How do we Fail an FDA Inspection”. Vikram Kulshreshta, a Senior Management Professional with a strong experience in Quality Assurance & Regulatory Affairs, will be the speaker at this session. Please visit…
ContinueAdded by Joseph Wilcox on February 27, 2019 at 4:48am — No Comments
Traininng.com, a well-known provider of professional training for all the areas of regulatory compliance, will organize a 60-minute webinar on the topic, “The New EU Medical Device Regulation”, on February 21. Dr. Salma Michor, who is the founder and CEO of Michor Consulting Schweiz GmbH, who teaches regulatory affairs and clinical strategies at the University of Krems, Austria, and is an independent expert to the European Commission, will be the speaker at this valuable…
ContinueAdded by Joseph Wilcox on February 25, 2019 at 6:49am — 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
Traininng.com, a leading provider of professional training for all the areas of regulatory compliance, will organize a webinar on the topic of HPLC Analytical Method Development and Validation, on February 21. John Fetzer, a senior professional in HPLC methods, will be the speaker at this session.
Please visit http://bit.ly/2SEmev3 to enroll for this webinar and gain insights into the core aspects of how to carry out…
ContinueAdded by Joseph Wilcox on February 21, 2019 at 6:14am — No Comments
This course will provide an overview of the requirements for aseptic and bulk manufacturing operations, including facility design, contamination controls and acceptable personnel behaviors.
Cleanroom classifications and the techniques for proper cleaning and disinfection are presented; along with a high-level overview of microbiology in regards to cleanroom environmental monitoring and the associated impact to product and patient health and safety.
This course will also review…
ContinueAdded by Joseph Wilcox on February 20, 2019 at 6:33am — 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
The aim of this webinar is to provide an introductory overview of the requirements demanded by the FDA and EMA (arguably the two most important regulatory authorities for drug developers) for EIM (the IND and IMPD) and to provide an brief review of where the agencies differ as well the commonalities of approach for their EIM dossiers.
Although each regulatory authority publishes guidelines and instructions regarding the requirements for the Entry Into Man (EIM) of a new…
ContinueAdded by Joseph Wilcox on February 18, 2019 at 5:21am — 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
Preliminary risk assessment (e.g., Likelihood X Impact) and the results of previous audits (e.g., number of NCs) are often used to help prioritize the audit schedule. While these are worthwhile to consider, they do not necessarily reflect the real-time performance of the processes that could be included in the audit plan. This means many audits are likely investing time and human resources in looking at processes that are performing adequately, while others that might be at greater risk are…
ContinueAdded by Joseph Wilcox on February 13, 2019 at 6:13am — No Comments
Traininng.com, a leading provider of professional training for all the areas of regulatory compliance, is organizing a webinar on the topic, “Tax Evasion and Tax Fraud. What it means to you when monitoring BSA and filing SARs”.
Doug Keipper, a Certified Anti-Money Laundering Specialist (CAMS) and a former Bank Secrecy Act officer and compliance officer, will be the speaker at this webinar. Please visit…
ContinueAdded by Joseph Wilcox on February 6, 2019 at 6:33am — No Comments
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