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

Featured Article

FEATURED BOARD MEMBER
David W. Vincent
MPH, Ph.D.,
CSO
VTI Life Sciences
Read Bio

Evolving from ALCOA+ to DYNAMIC+:
A Modern Framework for Data Integrity
Reshma Kodumuru, Principal CSV, KBI BioPharma

Abstract
With the rapid rate of digital change nowadays, ensuring data is secure and intact across complicated systems is the biggest challenge for the pharmaceutical industry. Government agencies such as the FDA, EMA, MHRA, and ICH all emphasize that trustworthy data, being complete, consistent, and accurate, is the foundation of product quality and patient safety. Audit trails are mentioned here as a basis for data integrity to facilitate 'who, what, when, and why' reconstruction of any change to the records.
Read More
Upcoming Complimentary Webinars
Microbial Contamination: Common Pitfalls and How to Avoid Them

June 25, 2025 | 11AM - 12 PM EST
REGISTER NOW
AI in Medical Device Validation: How to Automate and Optimize Compliance

July 9, 2025 | 11AM - 12 PM EST

REGISTER NOW
Preparing for GMP Inspections: What Regulators Are Looking For

July 23, 2025 | 11AM - 12 PM EST

REGISTER NOW
Industry News

ICH Q1 Guideline Under Revision:
Major Changes Ahead for Stability Testing

The ICH has released a draft revision of the Q1 guideline last April, marking a significant update to global expectations for stability testing of drug substances and products. This revision consolidates previous Q1A–Q1F guidance and introduces enhanced considerations for bracketing, matrixing, and predictive modeling. It also emphasizes lifecycle management and alignment with risk-based principles. Stakeholders are encouraged to review the draft and submit comments during the public consultation period. Stay tuned—these changes could reshape how companies design and manage stability programs.
READ MORE
This Month's Dose of Knowledge

Staying Motivated and Productive During Summer in Life Sciences

As summer approaches, life sciences professionals can enhance their productivity and motivation by implementing strategies that foster focus while still embracing the joy of time off.

Set Clear Goals and Objectives: As the summer begins, it’s easy for focus to drift with vacations and long weekends on the horizon. To combat this, set clear, attainable goals for the season. For example, a team might aim to complete a specific research project before the summer holiday rush. By breaking down tasks into manageable steps and implementing a timeline, you can maintain productivity while still enjoying your time off guilt-free.

Foster Open Communication: With schedules becoming more varied during summer, open communication becomes vital. Consider implementing a “summer check-in” routine where team members share their project status and summer plans. For instance, if someone is going on vacation, they can outline how their responsibilities will be managed, ensuring that workflows remain steady even when they’re away. This transparency helps maintain team cohesion while allowing everyone to relax during their time off.

Invest in Continuous Learning: Summer can also be an excellent opportunity for learning, but make it enjoyable! Encourage team members to attend workshops or conferences that coincide with their vacation plans—like a local biotech conference near a beach. By integrating learning with leisure, you can make professional development feel less like an obligation and more like an enriching experience. Sharing fun summer learning experiences can also foster team bonding.

Recognize and Celebrate Achievements: Use the summer vibe as a reason to celebrate accomplishments! Perhaps after submitting a critical report, the team could enjoy a picnic or a casual barbecue. Sharing highlights at summer team gatherings helps acknowledge hard work while reinforcing camaraderie. Plus, it allows everyone to unwind together, blending productivity with relaxation.

Promote Work-Life Balance: Summer is meant for enjoying the outdoors, long evenings, and brief escapes. Encourage your team to embrace this by setting flexible working hours that accommodate summer schedules. For example, if someone prefers to work early in the morning to enjoy sunny afternoons, allow for flexible hours. Lead by example by taking time off for a family trip or a hiking adventure, showing that it’s vital to recharge. This promotes a culture where everyone feels empowered to find their balance.

By incorporating these strategies, life sciences professionals can maintain focus during the summer months while also enjoying the well-deserved breaks. Striking a balance between productivity and leisure can lead to a more motivated team that feels energized and connected.

Upcoming Events
In-Person Conferences
Sterility Assurance University
Advancing Microbiology, CCS, Cleaning Validation, EM & Digital Tools Across the Lifecycle
August 5-6 | Attend Virtually or Philadelphia, PA

LEARN MORE

Medical Device University

AI • QMSR • Global Compliance • Cybersecurity • CSA
September 18-19 | Attend Virtually or Philadelphia, PA

LEARN MORE
GMP University

Modernizing GMP Processes from Risk to Inspections

October 8-9 | Attend Virtually or La Jolla, CA

LEARN MORE
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 }}