VIEW UPCOMING WEBINARS
KENX is excited to offer you our upcoming complimentary webinars!
Each webinar focuses on relevant industry topics given by our leading subject matter experts.
Simply register below and you’ll also become a KENX member which will entitle you to complimentary bonus materials, SOPs, tools & templates, and much more!
Ensuring Data Integrity for GxP Spreadsheets – Issues and Solutions
September 16, 2020
11:00 AM — 12:00 PM
In the first part of this webinar, we will review the reasons for their popularity as well as interesting anecdotes about spreadsheet errors. We will understand common issues and problems, by analyzing warning letters related to spreadsheets, and go into much detail on what Part 11 compliance means when applied to spreadsheets.
Data Integrity Findings, 483 & Warning Letters – What is the FDA looking for?
September 3, 2020
10:00 AM — 11:00 AM
On December 2018, the FDA published the Final Guide for Data Integrity in the regulated industry. But even before that, the FDA has been pounding the industry with findings related to Data Integrity. All FDA-regulated companies are currently working on Data Integrity and everybody is talking about the topic. Are we really focusing on the facts we should be focusing? Which observations the FDA has been finding on the audits?
COMPLIANCE IN THE TIME OF COVID: EVALUATING PROMOTIONAL ACTIVITIES
August 18, 2020
11:00 AM — 12:00 PM
The COVID-19 pandemic has resulted in pharmaceutical and medical device manufacturers having to devise alternative, often remote or virtual methods to interact with health care providers and patients. Some of these activities had already raised heightened scrutiny from enforcement authorities before the pandemic. But the necessity of the situation continues to drive these interactions in increasing numbers, without tried and true compliance techniques to address potential risks.
SALES REPRESENTATIVES ON THE BRINK OF EXTINCTION? THE FUTURE OF MSLS & MEDICAL
September 2, 2020
11:00 AM — 12:00 PM
In recent years, the Medical function within pharmaceutical and biotech companies has grown exponentially—some say to the point of eliminating the need for sales representatives. Many health care professionals view MSLs and other Medical personnel as trusted resources, who are able to provide information not only about the company’s product, but also about current research and trends in the treatment of patients with a particular disease. Key opinion leaders look to MSLs to help them wade through the morass of published data and to provide insights on health outcomes and the real-world effectiveness of drugs that they can use in the exam room. As personalized medicine becomes the norm, the need for medical education from highly trained scientific professionals on the use of these complicated products will only grow.
CRITICAL STEPS IN CONTROLLING MICROBIAL CONTAMINATION
September 23rd, 2020
11:00 AM — 12:00 PM
With patients’ lives on the line, mitigating microbial risk contamination is imperative to pharmaceutical product quality and safety. The ultimate cost of inadequate microbial control within pharmaceutical facilities is tremendous as production may have to be shut down for lengthy periods of time in order to conduct investigations and identify the root cause to prevent reoccurrence, loss of potential profit or consumer death.