About Me (Extended Remix)

Brendan Hyland
M. Eng., RQAP-GLP

I have been working in the GxP world since the early 2000's, when the engineering consultancy I worked for asked me to start

"researching into this GLP thing"

for a cost and scope estimate.

I had lucked into being the junior member of a talented engineering team that included some of Canada's foremost experts in drug development and manufacturing. We were managing a multi-million dollar international project to develop a nerve agent antidote.

Nerve. Agent. Antidote.

This was a three-in-one therapy for use by first-responders and soldiers in the field after exposure to a range of nasty chemical weapons. It was a dream project - full of technical problems to solve, multi-discipline, and a great team of experts to learn from.

As you might imagine though, there were a few unique complications to this project.

To start with, there was no supplier of the main active pharmaceutical ingredients (API). Besides not being commercially relevant, one of the chemicals for synthesizing that API was banned in all OECD countries for being highly explosive and carcinogenic.

The medicine was to be delivered in a novel three-compartment autoinjector, also not available off the shelf. The autoinjector needed to be usable by and on someone in full PPE, wearing thick gloves. It also needed to be quick and effective.

Into the Deep End

To top it all off there was literally one lab in the whole world who could do the GLP and 'animal rule' safety studies on this product - studies that would be needed for regulatory approval in any of the countries that wanted to stockpile the product. And that one lab wasn't 'available' to us.

So the team decided to see what it would take to roll our own! Specifically, to take a decades old Canadian government research laboratory in the middle of the prairie, and

"just make them"

GLP compliant.

Easy, right?

Of course with everything else going on, this simple side project fell to the junior member of the team. Me.

And Now you Have a Shark Problem

So I got busy and wrote a gap analysis, cost and scope estimate to bring GLP study capability to the research laboratory. It included a new laboratory, instruments, a full quality system and training for the staff. We had to target both OECD and FDA compliance since Canada at the time didn't have a monitoring authority for health studies.

We eventually also grew the scope to include the BSL-3 laboratory on the same campus.

The whole plan assumed we'd find some fancy GLP consultant to run it for us, while the rest of the team focused on designing the autoinjector, developing a new industrial scale API synthesis pathway, and finding a facility to make the product.

As it turned out, the only such consultant practising in Canada was looking to retire and not taking any new work.

The client said

"You wrote the plan, why don't you do it"

You Wrote It, You Do It!

So I did.

I spent the next couple of years managing the project, training myself up in GLP and other quality systems concepts, and then turning around and training their staff.

But mostly I wrote SOPs and built forms. Lots of them.

Fast Forward a decade or two

Since then I've been working with clients in GLP, GMP and now

GPP

facilities with all sorts of quality projects from SOPs to computerised systems validation, to audits, inspections and training.

A foray into the Wild West of Cannabis Quality Assurance...

Three years ago I agreed to help a Canadian Cannabis extraction startup. They were building a large

GPP

extraction facility to produce CBD extracts from industrial hemp using super- and sub-critical Co2 extraction.

At first they thought all they needed was my experience on paper: to show they had a QAP on retainer for the licensing application.

Pretty soon I became a key part of their management team as we built up the facility, its quality systems, and navigated the licensing process. I stayed on as remote QAP through the first couple of years of production, working with a great on-site team to produce, develop and release a whole range of high quality CBD and Cannabis products.

Putting it All Together

Over the years I've run QA departments remotely, built quality systems from the ground up, and even helped companies hammer their square off-the-shelf SOPs into round holes. I've built bespoke software to help automate data acquisition and produce audit trails in older systems.

I've written, reviewed and fixed

hundreds

of quality systems documents such as SOPs, forms, MBRs, specifications and validation plans. I've seen the good, the bad and the ugly, and personally felt the pain of being governed by badly designed SOPs, MBRs, forms and validation documents.

The most common reason for problems? The only real design effort that was put into these documents was to make sure the regulatory/Quality System checkboxes were satisfied.

I believe...

...that front-loading effort into an intentional design of regulated processes will pay back multiples in your day-to-day operations. It's not always easy, but with the right tools and techniques it can be made simple.

I consider it my mission to help regulated companies move beyond just compliance, to improve data integrity, product quality and process efficiency

Let's Go Beyond Compliance

Quality systems can truly shine when you're equipped with the right tools and techniques to incrementally build quality into the very design of your processes.

Join me

every weekday and explore how to make incremental improvements that design quality and efficiency into your systems. I'll help you learn how to:

Front-load effort to

increase quality

and

reduce day-to-day running costs

Design SOPs and forms to improve data integrity, simplify compliance and increase operating performance

Design and build high quality, reliable spreadsheets that can be compliant while also

simple to validate

Use computerized systems validation (CSV) to provide value beyond simply satisfying a regulatory checkbox.

Subscribe to the Daily HaiQu!

Join me every weekday as we take a few minutes to explore, design, test and improve the critical systems we use in our regulated facilities. From spreadsheets and software to SOPs and forms and beyond.

Subscribe Now!

We'll never share your email. Unsubscribe any time.

What do people say about working with Brendan?

We were running a complex, multi-phase pharma project that included planning and designing a quality system from scratch in a rather challenging environment. I brought Brendan in to help us out, and he quickly became an integral part of our team through multiple successes. With his multi-disciplined approach, an eye for detail and a willingness to ask the difficult questions, Brendan helped us accomplish what others said was impossible.

Gordon Cowan

, P. Eng., President, UGM Engineering

If you need someone to provide deeper insights into your QMS or to train staff, I would definitely recommend they hire Brendan. Overall, I was happy with the experience and would like to find opportunities to work together again.

Wayne Jackson

, P. Eng., Chief Operations Officer, Endless Sky Inc.

I would definitely recommend Brendan's services - he is a jewel to work with!

Debi Garvin

, MS, RQAP-GLP, Pacific Rim Consulting and Training