September 2024

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INDUSTRY NEWS
Stability Considerations for Drug-Device Combination Products-21 CFR Part 4 Update

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Email: info@kenx.org
Phone: 858 649 3251

KENX Insight – A Peer-Reviewed Journal Focused on GMPs and Validation

In the ever-evolving landscape of the pharmaceutical industry, the need for stringent validation and adherence to Good Manufacturing Practices (GMPs) cannot be overstated. These practices ensure that products are consistently manufactured according to quality standards and safeguarding public health. Despite their critical importance, there remains a significant gap in the dedicated platforms for the exchange of knowledge, research, and innovations specifically focused on validation and GMP. This is where the inception of KENX Insight, a peer-reviewed journal dedicated to these topics becomes not only relevant but essential.
Currently, information on validation and GMP is scattered across various journals, industry publications, and regulatory documents. A dedicated journal would centralize this knowledge, making it more accessible to professionals in the field to stay updated with the latest research, regulatory changes, and technological advancements. KENX Insight can serve as a beacon for industry best practices. By showcasing case studies, success stories, and innovative solutions, organizations can drive towards more efficient and compliant operations.

In addition, KENX Insight can serve as a platform for collaboration among scientists, researchers, and industry professionals. The GMPs and Validation community can share insights and experiences, address common challenges, and foster a culture of innovation. Consequently, it will improve product quality and then patient safety. KENX Insight can provide invaluable educational resources for emerging trends in GMPs and validation.
Benefits of Supporting the Journal
Contributing to and supporting a peer-reviewed journal enhances the credibility of professionals and organizations. It demonstrates a commitment to the highest standards of quality and compliance, which can be a significant differentiator in the competitive pharmaceutical industry. Participation also means opportunities to influence industry standards and practices, which may in turns shaping the future of validation and GMPs.
Being involved with the journal provides numerous networking opportunities. We have an esteemed editorial board, with whom contributors can connect with leading experts, researchers, practitioners fostering relationships that can lead to future collaborations or career advancements.
How to Participate
One of the most direct ways to support the journal is by contributing high-quality articles. Sharing your research, case studies, and insights helps build a robust body of knowledge that benefits the entire community.
You can also join the Reviewer Team to ensure the journal maintains rigorous standards. Reviewers play a critical role in assessing the validity, significance, and originality of submitted work.
In brief, establishing a peer-reviewed journal focused on Validation and Good Manufacturing Practices is a necessary addition to the pharmaceutical industry. As the industry faces increasing scrutiny and higher standards, having a dedicated platform to disseminate information, facilitate collaboration and encourage innovation is crucial.
By supporting this initiative, professionals and organizations can play a pivotal role in advancing the field, ensuring the highest quality and safety remain at the forefront of pharmaceutical manufacturing.
We invite you to join us in this important endeavor and take part in shaping the future of pharmaceutical manufacturing. Together, we can build a comprehensive, accessible, and influential resource that will drive the future of validation and GMPs, benefiting the industry, and ultimately, the patients we serve.
Truly yours,
Kim Huynh-Ba
KENX Insight Editor-in-Chief
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RESOURCES
21 CFR Part 4 is a regulation established for combination products, which are products that combine drugs, devices, and/or biological products. This regulation clarifies how cGMP applying to this class of pharmaceutical products and provides a framework for manufacturers to develop new products.
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September's Dose of Knowledge

Embrace the Power of Time Management:
Refocusing This Fall with Time Blocking
As we transition into September and gear up for the fall season, it's the perfect time to reassess our priorities and refine our daily routines. With the hustle and bustle of summer behind us, now is the ideal opportunity to harness the power of effective time management to achieve our goals and maintain a balanced lifestyle.
Time blocking is the allocation of specific blocks of time for different tasks or activities throughout your day. This could include periods for focused work, meetings, breaks, and personal activities. By assigning dedicated time slots, you can maintain better focus and minimize distractions, ensuring a balanced and productive schedule.
As we enter this new season, commit to purposeful planning and watch your efficiency soar, setting the stage for a successful and fulfilling fall!
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