A Peer-Reviewed Journal Focused on GMPs and Validation
April 2025

Featured Article

FEATURED BOARD MEMBER
Ken Shitamoto, MS
Senior Director IT
Gilead Sciences
READ FULL BIO

Unleash the Technology Disruptors and Revolutionize Lab Workflows

Kim Huynh-Ba, Managing Director, Pharmalytik, LLC

Efficiency in laboratory operations is essential for maintaining accuracy, reducing turnaround time, and ensuring compliance with regulatory requirements. As technology advances, laboratories can leverage automation, artificial intelligence (AI) and machine learning (ML), cloud-based Laboratory Information Management Systems (LIMS), and real-time analytics to streamline workflows, optimize processes, and improve product quality. These innovations enhance productivity, improve data integrity, and support better decision-making. This paper explores how these four key technological advancements contribute to laboratory efficiency and demonstrating their impact.

Read More
Complimentary Webinar
Strengthening Laboratory Data Integrity: Regulatory Frameworks for Control and Security
Wednesday, April 9 | 11AM - 12:00PM EST
Presenter:
Kim Huynh-Ba, M.S., FAAPS, Managing Director, Pharmalytik LLC; Adjunct Faculty, RAQA Program, Temple University
Overview:
  • Review current regulatory expectations for Data Integrity
  • Spot common lab data issues and how to avoid them
  • Strengthen documentation and record keeping practices
  • Improve system controls and data security measures
  • Promote a culture of accountability and data ownership
REGISTER
Industry News
FDA Finalizes Rule Aligning Medical Device GMP with ISO 13485:2016
New QMSR Regulation to Take Effect February 2026
On January 31, 2024, the U.S. FDA issued its long-anticipated final rule amending the current good manufacturing practice (CGMP) requirements for medical devices. The updated Quality Management System Regulation (QMSR) formally aligns FDA’s regulations with ISO 13485:2016, marking a significant step toward global harmonization. This move is intended to reduce compliance burdens for manufacturers and enhance global supply chain efficiency, with the rule scheduled to take effect on February 2, 2026.
👉 Read the full FDA QMSR Final Rule and FAQ
This Month's Dose of Knowledge
April Insights: Tips to Thrive This Spring
April, marking mid-spring in many regions, offers a blend of opportunities and challenges. As unpredictable weather and rising pollen levels become the norm, it’s wise to dress in layers and keep allergy remedies handy. The month also brings vibrant plant growth and seasonal produce ready to be enjoyed. Whether navigating school projects or changing work priorities, these tips help optimize health and productivity during this dynamic time of the year.
  1. Increased Daylight and Mood Improvements
    Longer days and more sunlight can uplift mood and reduce symptoms of seasonal affective disorder (SAD).
    Tips: Spend time outdoors to soak up sunlight, which can boost vitamin D levels and improve energy. Take up activities like walking or gardening to leverage the mood-enhancing qualities of spring.
  2. Seasonal Allergies
    Blooming plants and pollen can trigger allergies, causing sneezing, runny noses, and itchy eyes.
    Tips: Monitor pollen forecasts and limit outdoor activities on high pollen days. Consider using air purifiers indoors, and talk to a healthcare provider about over-the-counter or prescribed allergy medications.
  3. Wildlife and Outdoor Activities
    Wildlife becomes more active, and warmer temperatures encourage outdoor activities such as hiking and cycling.
    Tips: Use this time to increase physical activity for better health. Stay safe by wearing appropriate gear, staying hydrated, and being aware of local wildlife.
  4. Flooding Risks
    Melting snow and spring rains can lead to flooding in some areas.
    Tips: Stay informed through local news. If you live in a flood-prone area, prepare by having an emergency kit ready and knowing the evacuation routes.
  5. Allergies and Spring Cleaning
    Spring cleaning can stir up dust and allergens, despite the need to refresh and declutter homes.
    Tips: Use masks and hypoallergenic cleaning products during cleaning sessions. Regularly change air filters and vacuum with a HEPA filter to minimize allergens indoors.
By being aware of these changes and taking preventative measures, you can enjoy the positive aspects of spring while minimizing any physical discomforts!
Upcoming Events
In-Person Conferences
Laboratory University: Mastering Analytical Methods,
Stability Testing, And QC Excellence
May 14-15, 2025
ATTEND VIRTUALLY OR IN SAN DIEGO!
DOWNLOAD AGENDA
REGISTER
CSV & CSA University Europe 2025
Ensuring Compliance and Integrity Across Traditional,
Digital, and AI-Driven Systems
June 4 - 5
ATTEND VIRTUALLY OR IN CORK, IRELAND!
DOWNLOAD AGENDA
REGISTER
Harness The Power Of AI In GxP:
Use Cases, Process Optimization, And Validation
June 11-12, 2025
ATTEND VIRTUALLY OR IN PHILADELPHIA!
DOWNLOAD AGENDA
REGISTER
Sterility Assurance University: Advancing Microbiology, CCS, Cleaning Validation, EM & Digital Tools
August 5-6
ATTEND VIRTUALLY OR IN PHILADELPHIA!
DOWNLOAD AGENDA
REGISTER
REVIEW OUR CALENDAR FOR ALL CONFERENCES, WEBINARS & ON-DEMAND TRAININGS

Elevate Your Career - Become A Member​
Are you looking to learn from industry leaders?
Do you need insights on the current issues in the life sciences industry?
Become a KENX Member and gain access to webinars, articles, and networking opportunities with like-minded industry professionals. Join us today!
DISCOVER THE BENEFITS OF MEMBERSHIP

Join Our Dynamic Peer-Led Newsletter Team
Meet The Editorial Advisory Board
Contribute by writing insightful articles, becoming an Article Reviewer, or explore our Speaker Opportunities.
Your participation not only enhances your own expertise, but positions you as a sought-after subject matter expert.
Get Involved!
Showcase Your Talents!
START NOW!
LEARN MORE ABOUT OUR BOARD MEMBERS HERE

CONTACT US
info@kenx.org
858-649-3251
Making the life science industry a safer place…and loving every minute of it!

We have spent the past three decades on an epic ride through the life science industry. With early beginnings in the FDA and globally-regulated environment, we understand the importance of exchanging knowledge to make drugs and devices safer, and equipment and processes more scientifically sound. In the end, exchanging knowledge not only improves lives, but also saves them.
Whether you attend one of our interactive conferences or webinars, or take advantage of our valuable free process documents; our goal is to provide tools and techniques that will have an instant impact on your core responsibilities.

CONFERENCES
WEBINARS
MEMBERSHIP
ALLIANCES
Connect With Us!
LinkedIn
Facebook

31 E Kings Highway , 2nd Floor, Haddonfield, NJ 08033
Email by Solutions for Growth
© 2024 KNEX. All Rights Reserved
No longer want to receive these emails? {% unsubscribe %}.
{{ organization.name }} {{ organization.full_address }}