Behind the Scenes: My Role in Commissioning, Qualification and Validation

Welcome To Our Latest Edition of "Temperature Matters"

In this edition, I wanted to provide you a behind the scenes looking to my background in Temperature Mapping and Validation.

Whether you're a newcomer to the concept of temperature mapping or seeking to enhance your existing protocols, "Temperature Matters" is your go-to resource for all things related to temperature control in the critical environments of the Health & Life Science sector.

Firstly, a heartfelt thank you to our incredible sponsors, whose support allows us to share this knowledge on LinkedIn at no cost. Your dedication to our community is deeply appreciated.

Today's issue is brought to you by:

Did you know that even a slight variation in temperature can compromise the integrity of pharmaceutical products? Accurate temperature mapping is essential, but many professionals find it challenging to execute effectively.

Temperature mapping involves measuring and documenting temperatures within a storage area to ensure consistency and compliance. Yet, many struggle with placing sensors correctly, developing proper protocols, and meeting industry standards.

Navigating the complexities of temperature mapping can be overwhelming. Inconsistent data, unclear guidelines, and the risk of non-compliance can leave you feeling uncertain and frustrated.

That’s why I created Six Steps to Effective Temperature Mapping. This eBook breaks down the process into clear, manageable steps. Whether you're defining temperature mapping, conducting equipment inspections, or generating qualification protocols, this guide has you covered.

Introducing the eBook: In Six Steps to Effective Temperature Mapping, you'll find:

• Clear and Concise Format: Information presented straightforwardly and accessibly.
• Learning Objectives: Goals for each chapter to help you track your progress.
• Step-by-Step Guidance: Detailed instructions on essential topics like sensor placement and protocol creation.
• Practical Tools: Templates and tools to streamline your mapping efforts.
• Industry Best Practices: Proven methods to ensure compliance and efficiency.
• Regulatory References: Guidance aligned with ISPE, USP, and WHO standards.

This eBook is a valuable resource for anyone looking to improve their temperature mapping practices. It's designed to adapt to your facility’s unique needs, ensuring accurate mapping, resource optimization, and product safety.

Ready to enhance your temperature mapping skills? Get a copy of Six Steps to Effective Temperature Mapping today and gain the confidence to ensure your controlled environments meet the highest standards.

Because when it comes to temperature, Temperature Matters.

Get Your Copy

If you would like a FREE PDF copy of my Temperature Mapping eBook, please reach out to me directly, and I will be happy to forward it to you. Don't miss this opportunity to enhance your temperature mapping skills with expert guidance.

Leading the Way in Pharmaceutical Validation and Commissioning

Since 2000, I've been at the forefront of supporting key pharmaceutical clients, starting with pilot plant startup and commissioning to lab equipment moves, cybersecurity, and remediation of GLP and GMP equipment. Over the years, my commitment to excellence has driven me to generate and execute various qualification protocols, such as FAT/SAT, commissioning protocols, and IQ/OQ/PQ, ensuring the highest standards of quality and compliance. Here's just a small glimpse into my extensive support:

Key Contributions:

• Building Process Control Systems (PCS)
• HVAC Systems
• Warehouse Mapping
• Water for Injection (WFI) Systems
• Clean Air (CA) Systems
• Pilot Plant Support Equipment: Autoclaves, glass washers, and CIP skids
• Process Equipment: Bioreactors, mixing & holding tanks, transfer panels, and more

Lab and Equipment Support:

• Controlled Temperature Units (CTUs)
• Centrifuges
• Plate Readers/Washers
• Biological Safety Cabinets (BSC)
• Disposable Wave Bioreactors
• Tube Welders

My role extends beyond equipment; I've been pivotal in every major equipment relocation and have fully validated and managed GLP laboratories across multiple sites. My ongoing validation support spans several locations, including several countries. I am proud to support GMP and GLP functions and Global Engineering initiatives for my clients.

Major Milestones:

• 2000 Process Validation Project – Retrospective Validation: I served as a key member of the validation team, specifically focusing on the LOC (Liquids, Ointments, and Cream) department. This project was critical for ensuring that all manufacturing processes met the required standards and were properly documented.
• 2003 Pilot Plant Commissioning and Qualification: I served on the validation team and provided resources to the QA Validation department.
• 2009 Manufacturing Center Commissioning and Validation: I served on the construction management team, led a group of engineers, and provided resources to the Global Engineering and Validation teams.
• HVAC Dehumidification Project: Showcased my expertise in commissioning and qualification (C&Q) processes by writing and executing test scripts to verify the controls and alarms of the air handler on the building management system (BMS).
• 2010 Research Validation Department: Provided validation support services and project management for multi-site regulated Research labs (Gaithersburg, Mountain View, and Cambridge). Supported GLP-trained validation services to meet Translational Sciences equipment qualification objectives and Research Validation program management requirements, all in compliance with FDA GLP regulations (21CFR58 Good Laboratory Practice for Nonclinical Laboratory Studies).
• 2017 SME/Compliance Lead: Provided consultative guidance to overcome project obstacles and inefficiencies, peer-reviewed validation SDLC documentation, and mentored junior personnel. I drove standardization in service delivery, ensuring quality and compliance, while fostering synergies between the validation and lab computing teams. Additionally, I managed project strategy, planning, and implementation, ensuring compliance, monitoring progress, and continuously seeking process improvements for successful project delivery.
• 2020 Large Scale Cell Processing Modular Facility: My contributions were instrumental in the successful commissioning and qualification of this groundbreaking project, being the first large-scale, fully prefabricated, and modular multi-module cGMP manufacturing facility in the US, supporting its mission to deliver innovative cancer treatments.

My dedication to validation and commissioning is unwavering. As I continue to support my clients, I’m always ready to assist with any upcoming needs, including LinkedIn questions about temperature mapping and validation.

Current Focus:

In my current role, I am deeply involved in temperature mapping and validation. This includes developing content, training professionals, and ensuring compliance with industry standards. My eBook, "Six Steps to Effective Temperature Mapping," provides a comprehensive guide for conducting temperature mapping studies efficiently. Additionally, as a co-contributor to the ISPE Good Practice Guide for Controlled Temperature Chambers, I am committed to sharing valuable insights and best practices with the industry.

I regularly contribute articles to Lab Manager and other industry publications, aiming to educate and inspire professionals globally. My mission is to drive efficiency, integrity, and excellence in validation and temperature mapping, ensuring a safer, healthier future for all.

Stay tuned for more behind-the-scenes updates and insights into our ongoing projects and initiatives. Together, we continue to set the standard for quality and compliance in the health and life sciences industry.

Quote: "Everyone knows what needs to be done, but they’re not always sure how to get there. We know how to get there because that’s what we do, over and over again. We employ proven methods to guide our clients towards better solutions." - Nathan Roman ??

Stay Tuned:

Stay tuned for more insights and reflections in our upcoming editions. As we continue to navigate the complexities and advancements in our field, we'll share experiences, challenges, and successes that connect us all. Your engagement and feedback are not just welcomed; they are essential in shaping our journey together. So, let's keep the conversation going, learning from each other and striving towards excellence in everything we do. Thank you for being a part of this community.

Ready to Elevate Your Temperature Mapping Expertise?

Whenever you're ready, there are 3 ways we can assist you in mastering temperature mapping studies:

?? Explore Expert Insights: Subscribe and discover actionable tips, industry trends, and expert knowledge to enhance your skills.

?? Join the Pharma Temp Mapping LinkedIn Group: Gain access to in-depth content, practical workshops, and a community of fellow temperature mapping enthusiasts. Join here: Pharma Temp Mapping

?? Book a Call with Me: Schedule a personalized 30-minute call designed to help you take the next step in your temperature mapping journey. Receive tailored advice and insights to overcome specific challenges and enhance your expertise. Book A Call

Choose your path to temperature mapping excellence, and let's embark on this journey together. We're committed to your success in temperature mapping and look forward to journeying together.

I hope you're able to find value in this article. If you did, please subscribe to this newsletter and follow me on LinkedIn.

Warm regards,

Nathan Roman ??

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