Temperature Mapping Got You Stressed? | Let me help | Follow for Temp Mapping & Validation Insights ✨

What if I told you temperature mapping isn’t really about temperature?

It’s about protecting lives, ensuring compliance, and preserving trust.

While temperature is the data you’re measuring, the true goal lies beyond the numbers. It’s about safeguarding product integrity, ensuring patient safety, and upholding your organization’s reputation. Temperature mapping isn’t just a technical requirement—it’s a critical step in delivering life-saving products to those who need them most.

For over 24 years, I’ve helped life sciences companies elevate their validation processes—not just meeting global regulations but exceeding them. As a recognized thought leader in temperature mapping and equipment qualification, I’ve shaped industry standards, contributed to ISPE guidelines, and trained professionals worldwide.

Some highlights of my work include:
✅ Helping 100+ pharmaceutical and biotech companies achieve FDA & EU GMP compliance.
✅ Optimizing validation strategies to reduce timelines by up to 30% without compromising quality.
✅ Authoring industry-leading content and best practice guides.
✅ Educating and empowering professionals through training, articles, and thought leadership in validation, calibration, and compliance.

📈 With over 18K LinkedIn followers, I’m also an ISPE Good Practice Guide co-author and the author of Six Steps to Effective Temperature Mapping. My thought leadership has driven business wins, secured global speaking engagements, and positioned me as a trusted expert in the field.

So why isn’t temperature mapping about temperature? Because it’s about something far greater—the lives you’re protecting, the products you’re preserving, and the trust you’re building every step of the way.

Let’s connect to explore how we can take your validation process beyond compliance to deliver real impact.

🔍 #CQV | #Validation | #Qualification | #ISPE | #Entrepreneurship | #ContentCreation | #TemperatureMapping | #QualityAssurance | #LifeSciences | #ColdChain | #GMPCompliance

Nathan Roman 📈

Had a great week collaborating with my colleagues from Denmark, Switzerland and UK/Ireland! 

→ Strategy. 
→ Campaign planning. 
→ And... just a little bit of fun. 

When we align on what truly matters, share insights with openness, and stay committed to creating value, we build more than results - we build traction. Whether in business or life, clarity and connection turn vision into momentum. ☺️ 

Excited about the opportunities we are mapping for Ellab and the journey ahead!

#Ellabers #Strategy #Growth #Validation #Innovation

I help life science leaders reduce risk and increase confidence through proven CQV, calibration & asset management strategies - turning compliance headaches into operational wins with Ellab’s end-to-end solutions.

Quality and business performance are inseparable.

When a company faces an FDA inspection or a major audit,
it’s not just a test of systems -

it’s a test of trust.

And the people watching most closely aren’t always regulators or investors.
→ They’re your customers.
→ They’re your employees.

Recently, a vaccine manufacturer confronted serious FDA findings -
right in the middle of a pending acquisition.

Yet operations continued.
Customers stayed loyal.
Employees stayed focused.

Why?

Because leadership didn’t hide.
They stepped into the spotlight - owned the issue, communicated clearly, and moved fast to correct it.

That’s the real story:

Regulatory resilience isn’t built during a crisis.
It’s built every day before one.

It’s built every time your team:
✅ Updates documentation before an audit notice arrives.
✅ Treats CAPA as a process for learning, not blame.
✅ Communicates openly - inside and outside the company - when something needs fixing.

These daily habits build trust.
They protect not just your license to operate -
but your license to lead.

Because when confidence is shaken,
it’s not the process that saves you - it’s the people who believe in it.

I help life-sciences teams gain confidence and control in validation, calibration, and temperature mapping through clear, practical guidance that removes confusion, reduces risk, and strengthens quality outcomes.

Calibration & Validation — What's the Difference?

If you're working in — or breaking into — biotech, pharma, or lab operations, you'll hear these terms constantly. And they're not interchangeable.

✔️ Validation shows that a process or system consistently performs as intended.
✔️ Calibration ensures an instrument is accurate compared to a reference standard.

I wrote an article that breaks both concepts down in simple terms — when they're needed, how they're performed, and why they matter for quality and patient safety.

👉 Read the full article here: https://lnkd.in/eM6TiGeB

The table below gives you a side-by-side comparison to make the distinctions even clearer.

P.S. Does this structure make the distinctions clearer for your team or clients?

Nathan Roman: Validation & Calibration

My biggest lesson from the last 20+ years in validation?
We can’t keep using yesterday’s methods for tomorrow’s problems.

(Especially when the industry is becoming more digital by the day.)

Next month, I’m co-hosting an ISPE webinar with Michelle Vuolo and Tatiana Illgen called: 

"Unlocking Innovation: Embracing Validation 4.0 for a Digital Pharma Future"
 
And if your team is feeling the pressure to move faster while staying compliant - this one matters.

Because Validation 4.0 isn’t an upgrade. It’s a paradigm shift.

It moves us from:
❌ Fixed, static validation runs
❌ Paper-heavy documentation
❌ One-time “prove it once” thinking
❌ Slow evidence generation that delays release

To a model built for a digital pharma future:
✅ Real-time, data-driven evidence
✅ Scalable digital systems
✅ Continuous learning and improvement
✅ Stronger, leaner verification of control

And the best part?
It doesn’t replace fundamentals - it builds on them:
• Quality by Design
• Quality Risk Management
• Knowledge Management

We’ll walk through how this shift helps teams avoid bottlenecks, accelerate timelines, and maintain verifiable control in an increasingly digital environment.

What you’ll learn:
✔️ How Validation 4.0 removes traditional validation bottlenecks
✔️ How digital, real-time evidence speeds product release
✔️ 1–2 case studies showing this approach in practice
✔️ Why modern data systems are essential for GxP integrity
✔️ How to prepare your operations for this shift today

If your site, team, or projects still feel “stuck” in older validation ways - this is a good place to start fresh.

Register here: https://lnkd.in/eX9ZfSDf

👉 If you want to see more posts on CQV, temperature mapping, and validation strategy, be sure to follow me, Nathan Roman 📈.

#Validation40 #CQV #LifeSciences #AI #DataIntegrity #GxPCompliance #DigitalTransformation #ISPE

Every day there are professionals out there looking for clear, practical guidance.

❌ Not theory
❌ Not vague advice

But steps they can use on the job — today.

And here’s what often gets overlooked:

I don’t just talk about temperature mapping.

I talk about how work really moves across a GMP lifecycle — from concept → design → commissioning → qualification → monitoring → continuous compliance.

I speak across the entire compliance lifecycle:

→ Regulatory standards
→ Industry guides
→ Risk management
→ Process design
→ Validation strategy
→ CQV
→ Commissioning
→ IQ/OQ/PQ
→ Monitoring
→ Data integrity
→ Documentation

These are the areas teams wrestle with every day — and they deserve straightforward support, not complicated answers.

This new 9-step ULT freezer mapping guide is just one example of that commitment.

It’s for the people who want to work correctly, confidently, and without guesswork.

If you want the guide, be sure to click here: https://lnkd.in/drxZUuSs

🎯 Streamline your Next Validation or Qualification Project

Every successful ULT freezer qualification starts with a clear, structured process - one that saves time, reduces risk, and ensures compliance every step of the way.

At Ellab, we combine global expertise with local support to help life science companies navigate qualification and validation efficiently and confidently.

Our 9-Step Guide breaks down the full process from preparation to final reporting, helping you:
✅ Strengthen data integrity and audit readiness
✅ Reduce downtime and complexity
✅ Gain consistency across sites and teams

📘 Download the full guide and see how to optimize your validation and qualification projects here: https://lnkd.in/drxZUuSs

If you have doubts, ask the author Nathan Roman 📈 directly in the comments!

A 9-Step Guide to Temperature Mapping an Ultra-Low Freezer

Last night, I had the privilege of leading a remote session with professionals at Ellab Academy Singapore.

Participants didn't just attend - they got the chance to really take a look into temperature mapping and CQV fundamentals:

→ From foundational strategy → to flawless execution.

A big thank you to Nerissa Low, Nevil Ng, Roger Sanson and Bhavesh Panchal for the invitation and for including me in such a meaningful, global program. 🙏

It's truly inspiring to connect with professionals who share the same crucial mission:

- Improving quality
- Ensuring compliance
- Elevating patient safety

Even from across the globe, the curiosity, engagement, and unwavering commitment to doing things the right way was encouraging. That’s the power of Ellab Academy!

In this session, we focused on connecting principles with practice and building true confidence in data and systems.

We covered key topics that directly impact data integrity and successful validation:

✅ Determining sensor locations & numbers
✅ The role of mapping inside the CQV lifecycle
✅ Common mistakes that compromise data integrity
✅ How documentation turns data into defensible proof

P.S. 👇 If your team is planning an equipment qualification or a temperature mapping study and needs expert guidance on:

→ Protocol design
→ Sensor strategy
→ Execution support
→ Compliance documentation

Let’s talk!

👉 Send me a DM or book a short call - I’d be happy to help you plan your next successful study.

#Ellab #TemperatureMapping #CQV #Validation #Compliance #EllabAcademy #LifeSciences #Pharma

📸 Here’s a glimpse from the session in Singapore. If you missed this one, stay tuned for future Ellab Academy events around the world!

Happy Thanksgiving, LinkedIn Fam 🦃

Just waiting for the other family to show up.

In our house, we still have the adult table…
…and the “kids” table.

Except the kids are now 16, 17, and 18.
Time really does move fast.

Are you sitting at the adult table or the “kids” table this year? 😂 

Grateful today.
Grateful always.

Enjoy the day, however you’re celebrating.

No alternative text description for this image

Most companies don’t need another validation vendor.

They need a better outcome from the work they already pay for.

Here’s the question I always ask:

“If nothing changed with your current vendor, what would the next 12 months look like?”

If the answer is delays, rework, or qualification anxiety…

You don’t have a vendor problem. You have a system problem.

My solution:

The Vendor Upgrade Framework:
	1.	Identify friction
	2.	Map risk
	3.	Replace weak processes
	4.	Standardize documentation
	5.	Deliver predictable outcomes

This isn’t about switching vendors.
It’s about switching to predictability.

Want your validation done right the first time? I’m the easiest upgrade you’ll make this year—and the one that sets you up for a winning year ahead. 

Let’s work together! ✌️

Stop treating Commissioning and Qualification as separate hurdles.

Embrace an integrated C&Q process from day one.

A single, risk-based verification plan saves time, reduces cost, and accelerates your speed-to-market. It's that simple.

Legacy thinking keeps them apart. Modern practice brings them together. For detailed guidance, refer to the ISPE Baseline® Guide: Volume 5 – Commissioning and Qualification (Second Edition).

#CQV #Validation #Commissioning #ISPE #Ellab #Lean #Efficiency #ProjectManagement

They say you can't succeed alone, and these past couple of years proved it. 

These guys are the definition of 'all in.' 

They embody the energy, the strategy, and the heart brought to every single challenge we tackled.

I’ve been lucky to have partners who support me and who bring that unmatched 'Rod Tidwell' energy—pure loyalty and heart.

Help me help you... celebrate these guys! 🙌

Thank you for helping me accomplish so much. Here’s to your continued success—you guys deserve it all.

🎥: Gordie Tamayo and Joe Wilde

LinkedIn

JSESSIONID

Sign Up | LinkedIn

li_at

(3) Feed | LinkedIn

You don’t find the right team. 
You build it.

(And that changes everything about how you lead.)

Everyone talks about finding the “right people.”

The truth?

Leadership shapes the team into being right.

In honor of our vets this week, I’d like to share a story Mark O'Donnell once wrote on leadership and team performance.

https://lnkd.in/e_GxeGui

He said something that stuck with me: “There are no bad teams, only bad leaders.”

In the story, he shared how a struggling Navy SEAL team turned things around the moment their leader changed.

Same people. Different outcome.

It wasn’t talent that made the difference — it was leadership.

Mark also shared an example close to home: my own journey leading validation teams over the years.

He talked about how belief, humility, and teamwork built a high-performing group that’s stayed together for years and outperformed by 20% margin.

It’s wasn’t luck.
It’s not credentials.
It’s leadership — the kind that inspires, enables, and stays connected.

When leaders take full responsibility for outcomes, something powerful happens:

• Trust grows
• Performance rises
• Potential turns into proof

There are no bad teams — only leaders who haven’t found their rhythm yet.

Read more here: https://lnkd.in/e_GxeGui

If you’re leading a CQV, validation, or compliance project and need a partner who brings both leadership and technical depth — I can help.

Send me a DM or book a quick call to learn how I can help.

Who owns your state of control - and do they know it? 💡

Part 5 of our 'Temperature Matters' series reveals how to build and sustain a culture of thermal compliance. Empower your teams with targeted training and reinforce ownership across operations, QA, and facilities.

📖 Read now: Temperature Matters | Building a Culture of Control

Welcome to the final edition of Temperature Matters, closing our five-part series on the foundations of thermal compliance. Across the past four editi

Open article: Part 5: Building a Culture of Control by Nathan Roman 📈 • 9 min read

What if the risks you're managing during qualification are already too late? 

Part 4 of our 'Temperature Matters' series explores integrating QRM into every phase of mapping and qualification. Discover how ICH Q9 principles and performance data drive lean, robust strategies. 😁👍 

📖 Read now: Temperature Matters | The Role of Risk Management

Welcome to the latest edition of Temperature Matters, part four of our five-part series on the foundations of thermal compliance. Last time, we explor

Open article: Part 4: The Role of Risk Management by Nathan Roman 📈 • 9 min read

Most CQV delays aren’t technical failures.
They’re scheduling failures.

I’ve seen $2M+ projects sit idle because no one planned for CQV upfront.

Here’s what gets missed…

→ Document generation and review cycles
→ Execution windows and resource availability
→ Final report approvals

The 3 mistakes that kill timelines:

1. Late involvement

▪️Validation gets looped in after equipment is ordered.
▪️Now you’re retrofitting requirements instead of building them in.

2. No clear definition of “done”

▪️When is equipment qualified? When is the area validated? When can production start?
▪️Without defined acceptance criteria, you’ll debate this at the finish line.

3. Incomplete turnover packages

▪️Engineering hands off equipment without:
→ Calibration records
→ As-built drawings
→ Vendor documentation
▪️Now validation is chasing paperwork instead of executing.

The fix: CQV isn’t a phase at the end.

It’s a workstream that runs parallel to your entire project.

→ Budget for it. 
→ Schedule for it. 
→ Staff for it.

If you’re making these mistakes right now, you’ve got two choices:

1️⃣ Keep hoping the next project goes better (it won’t).
2️⃣ Or bring in someone who’s done this 1,000+ times.

I help pharma and biotech companies:

→ Build CQV into project plans from day one
→ Define turnover criteria that eliminate finish-line chaos
→ Execute qualification strategies that pass audits without drama

The companies I work with don’t scramble at the end.

They don’t delay production starts.

They don’t get audit findings on qualification gaps.

DM me “PROJECT” and I’ll show you exactly where the landmines are in your timeline. 👍🏻

Quality isn’t supposed to clean up everyone else’s problems.

Yet that’s exactly what happens.

If QA is discovering the issues, the process already failed.

Quality shouldn’t be the first to find the problem.

They should be the last.

Good systems make QA a confirmation step — not a rescue operation.

When QA is constantly firefighting, you don’t have a quality problem.

You have a process problem.

P.S. Does QA at your site spend more time preventing or reacting?

inglasia pharma solutions

Provision of GMP, GDP related consultancy and training services.
Advisor to private investors on the acquisition and setup of Pharmaceutical manufacturers and distributors
Interim Quality Director, Head of Quality and Senior QA Specialist titled roles responsible for:
Managing Global and local QA department Personnel and Quality System
Conduct GMP audits (Sterile, solid dose, liquids and API manufacturing)
Conduct GDP audits (Distributors, Wholesalers, Affiliate offices, carriers and brokers)
QA validation review & approval of ATIMP/ATMP manufacturing equipment and process
Support with acquiring EU GMP certification.
Support with acquire Wholesale Dealer Authorisation.
Inspection readiness and remediation.
Supply Chain Mapping Strategy and Risk Assessment
Named as Responsible Person on Wholesale Dealer Authorisation
Implementing Pharmaceutical Quality Systems in ATMP, sterile, solid dose and liquids manufacturing sites to meet MHRA/FDA regulatory requirements.
Implementing Pharmaceutical Quality Systems at distributor sites.
Support in completing User Requirement Specification (URS), design, qualification and validation and commissioning of R&D, commercial manufacturing and distribution facilities.
Developing creative and engaging GMP/GDP training courses.

Co-Founder /  Global Quality Advisor to the Pharma & Biotech Industry

Gilead Sciences

Managing audits of Gilead Affiliates and contracted warehouses in Europe, Middle East and Australasia (EMEA).

Supporting Affiliates in preparation for local GDP Regulatory Inspections.

Performing due diligence audits of potential new contract warehouses and submitting recommendations as part of the selection process.

Conducting GDP training to Affiliates and the Gilead manufacturing facility and distribution warehouses.

Auditing Gilead global manufacturing facilities to EU GMP standards.

Sr. Manager, Corporate Quality

United Therapeutics Europe Limited

Reporting to US Senior GMP/GDP Manager. Responsibilities include:

Implementing a robust QMS for managing all UK and European storage and distribution operations.

Manage comprehensive GMP/GDP compliance in Europe, for R&D and commercial. Manage direct report and track objectives and performance.

Planning and conducting external vendor audits. Drafting, implementing and maintaining Technical Agreements with vendors.

Review master assembly specs and completed packaging records prior to QP approval.

Pepare and maintain SOPs and systems required to comply with regulatory requirements. 

Manage product complaints and recalls from the European market.

GMP/GDP Manager

sanofi-aventis

Reporting to UK Head of Quality, and acting as designate UK Affiliate Quality Officer for Corporate sanofi-aventis. Role involved:

Releasing products to market from the UK distribution centre. I  was often delegated duties of the Responsible Person.

Understanding the regulatory authority requirements for marketed and clinical trial medicines and devices. Worked with UK Regulatory department to ensure variations implemented in a timely manner for legal compliance and patient safety.

Initiated and maintained technical agreements with subcontractor and company sites for cGMP, GCP and GDP activities. 

Managing a team handling product technical complaints on UK marketed and clinical trial medicines and devices. Identifying improvements to products and services to patient.

Implemented the internal and external audit programme and auditing of subcontractors to cGMP, GCP and GDP standards.
	
Raising the awareness of cGMP, GCP and GDP within the Head Office by providing training on quality SOPs.
	
Working closely with external customers, DOH, MHRA/DMRC, EMA and corporate quality colleaugues on identifying out of stock situations, ensuring that counterfeit products are investigated and assist with identification of defective medicines and devices within the UK and European market.

Led numerous projects in process improvement and communicating to all departments the importance of maintaining consistent quality standards through procedures and validated systems.

QA Manager

Generics UK Limited

Managed team checking batch records; Worked cross-functionally resolving deviations and out of specifications prior to QP review; Improved efficiency of existing QMS; Performed internal and external audits; Team player in gaining MRA for the site. Customer certificate generation;   Solving external customer queries. Checking and approving method validation work.

Senior QC Officer

Lanes Health

Performed internal/external cGMP and themed audits; Compliance review of manufacturing documents prior to QP release.

Designed and implemented qualification/validation studies; Performed root causes/corrective action investigations; Co-ordinated, controlled and performed cleaning validation activities; Maintenance of QMS documentation.

Compliance Officer

Novartis

QC laboratory work; Analytical testing; Stability testing; Wrote SOPs; Reviewed testing methods; In charge of service contracts; Worked on transfer projects.

QC Analyst

A pragmatic, efficiency and compliance driven professional striving to achieve the best Quality solution for his clients. a motivated team player, often working cross-functionally to ensure patient and product safety is consistently maintained.

Experienced Quality professional working with various clients in Pharmaceutical & Biotech industry.  Possessing a broad-based, detailed understanding and working knowledge of Global regulations on manufacture, storage and distribution of pharmaceutical medicines, cell and gene therapy (ATMP) and devices. 

Founder of a very successful discussion forum on Linkedin aimed at Pharmaceutical Quality Professionals globally (https://www.linkedin.com/groups/4107350). 
 
Leading successful projects  to implement and educate on the importance of Product Quality and Pharmaceutical Quality Management Systems and validation at Manufacturers, Warehouses, Affiliates and at Corporate levels. 

Some of the global clients served: Gilead, GSK, Autolus Therapeutics, Procter and Gamble, Galderma, Nestle, Crescent Manufacturing, Johnson & Johnson, CaligorRx, Lonza Biologics, Clovis Oncology, Aimmune Inc., Diversis Capital LLC, Candesic, Alexion, Yusen, PDP Courier, Xellia, AirLiquide, Hellmann Healthcare Logistics, Nippon Express and Yusen Logistics.

Aside from working profession, a motivational speaker, keen to support others to succeed in all areas of their lives - It's not who you are, it's who you become that matters.

Sanjay  N.

Another recall in the UK in 2025, due to rogue tablet in some blisters🤦‍♀️

Majority of medicinal product recalls are packaging related. Inadequate controls within the GMP processes and lack of attention from operators, due to poor management commitment to staff, results in these failures. 

Such mix ups can also cause cross contamination and adversely impact the wider batch and the end patient. Factors that may cause rise to this and other types of mix ups are listed below.

👉The close proximity or location of similar items;
👉Items having the same colour or combination of colours;
👉Multiple products handled at the same time/packaging;
👉Use of the same apparatus or equipment for multiple products;
👉Operator not vigilant during packaging and/or repackaging of products due to poor training/management support;
👉Mistakes made when dispensing;
👉No proper line clearance procedure;
👉Unused labels or earlier production left in the production area;
👉Improper documentation and labelling;
👉No ID code on materials or products;
👉Failure of the processing equipment;
👉Manual packaging and repacking;
👉Inadequate control or procedures;
👉Rejection of handling;
👉Improper affixing of labels;
👉Reprocessing;
👉Improper or lack of proper communication;
👉Same personnel handling two machines or equipment at the same time;
👉Lack of proper validation.

The above contributory factors should be considered within a risk assessment that looks at the likelihood of mix ups and cross contamination in packaging. This will provide data on where are the areas of risks and the mitigation actions to be implemented. This will significantly help in reducing the chances of having a recall in your hands!

If you would like to learn more on this topic, please like, share and follow me on LinkedIn.

www.inglasia.com

GMP/GDP Global Advisor l CEO l Founder of Largest Pharma/Biotech Quality LinkedIn Group l Motivational Speaker

taplio

The Battle

Nathan Roman 📈

Sanjay N.

Followers

Posts

Engagements

Likes

Performance ScoreNathan Roman 📈's LinkedIn Performance

Performance ScoreSanjay N.'s LinkedIn Performance

Ready to grow your LinkedIn presence?

taplio

The Battle

Nathan Roman 📈

Sanjay N.

Followers

Posts

Engagements

Likes

Performance Score.css-goub6s{font-size:var(--chakra-fontSizes-md);font-weight:500;color:var(--chakra-colors-gray-600);display:block;margin-top:var(--chakra-space-1);}Nathan Roman 📈's LinkedIn Performance

Performance ScoreSanjay N.'s LinkedIn Performance

Ready to grow your LinkedIn presence?

Performance ScoreNathan Roman 📈's LinkedIn Performance