What led you to volunteer with PDA?

I wanted to establish a chapter in the Pacific Northwest. The California chapters have been so successful, creating many amazing opportunities for people on the West Coast.

At the same time, it was challenging for PDA members in the Pacific Northwest to attend meetings in California due to geographical constraints. I hope this new chapter creates the same environment that brings people, science and technology together. It has been a truly incredible experience to get our chapter kicked off through support from PDA and the other chapters. I am now the President of the Pacific Northwest Chapter.

Of your PDA volunteer experiences, which have you enjoyed the most? Since I am still pretty new at this, I would say establishing the chapter, and, in particular, meeting our colleagues from both the Southern California and West Coast Chapters at the 2019 PDA Annual Meeting.

How has PDA contributed to your career?

PDA has supported my continued education by allowing me to network with industry experts in both the quality and regulatory space. Attending the PDA/FDA Joint Regulatory Conference is a highlight for me each year since I can hear from both regulators and industry leaders on the latest manufacturing, quality, supply and compliance issues.

What lessons has your work taught you?

My work life has taught me many lessons over the years. The most important has been how to create and build a strong team. When we are part of a great team, we know others have our backs and we feel supported and encouraged. We rise to face challenges together, exchange ideas, work through roadblocks, deliver on time, celebrate successes and learn from the failures along the way.

What was the last book you read?

I just read an amazing book, On Fire: The 7 Choices to Ignite a Radically Inspired Life, by John O'Leary. I would love to meet the author. His message is one of inspiration and that "gratitude unlocks the fullness of life."

How did you hear about PDA and why did you join?

I joined PDA in 2015. I was introduced initially by a colleague with whom I collaborated with on presentations for PDA conferences. The conference vibe hooked me immediately—the interactions with regulators and industry leaders, the sessions and the overall fellowship. All of this offered a link to staying current on the side of progress.

What are some of the volunteer projects you have been involved with?

I have been fortunate to serve on the PDA task force collaborating on technical reports addressing data integrity within laboratories, manufacturing and the quality management system. The team has been highly engaged, supportive and draws from diverse experiences.

What challenges do you see facing the industry?

The sweeping impact of big data and artificial intelligence has completely disrupted the data integrity regulatory paradigm, which is my area of expertise. I am fascinated and intrigued by this technology, and, equally so by all the collaborative work to define regulations, including data integrity requirements.

Who is your personal hero?

My father was a veteran. He was fierce on integrity. Character was everything. He was genteel but demanding of goodness, courage, humility and trust. If I fell short, he never raised his voice but would get a look of disappointment that could crush an army. A day does not go by that I do not reflect and draw upon his teachings.

What has been your once-in-a-lifetime experience?

When I was 38, I took a year off from my career and essentially went to live on an ashram. To partake in the community you must also serve, so I was the head of the kitchen. For the first six weeks I practiced Ashtanga yoga, meditated and studied Sanskrit from 4 a.m. to 9 p.m. I also cooked breakfast, lunch and dinner for the community in between programs.

The ashram received guests from all over the world, and for the remainder of the year, I taught yoga and cooked meals for these amazing people. Everyone was seeking mindfulness and working to align themselves with the principles of absolute love. It was a total awakening for me.

Why did you become involved in PDA Ireland?

The PDA is an exceptional organisation bringing together multiple disciplines in the area of parenteral medicines both in Ireland and Globally.

What has been your most recent volunteer role?

Annex 1 Conference Dublin, 2019 - I had a very junior role supporting Alan Kelly and the team at this highly informative and time-relevant event.

What led you to volunteer with PDA?

The PDA is about sharing knowledge, experiences, and challenges– both the good and the not so good. I saw it as a great way to build up my network of people who are dedicated to patient safety and operational excellence and also to give something back to the industry that has been very good to both myself and my family.

What significant changes have you seen in your area of expertise?

Focus on Patient Safety or as Ann McGee puts it Beyond Quality. We are fortunate in Ireland to have superb manufacturing facilities which are the envy of many outside of Ireland – however, we need to keep up the momentum.

What is the best piece of advice you have ever received?

Listen to others – focus on their needs and what do they need to hear not what you want to say.

Whom would you choose to switch places with for a day?

Jack McCaffrey - what an all-rounder. A perfect gentleman both on and off the pitch.

Why did you become involved in PDA Ireland?

I had attended many PDA events over the years because they were topical, of great value & provided an excellent mechanism for networking. Through engagement with active PDA members within Eli Lilly & Company and externally, I recognised the significant benefits that PDA brings to all sectors of the life sciences. PDA offers an incredible platform for the industry at a local chapter level and globally in enabling an industry voice to help to shape the future of science and regulation. The Irish chapter members have great energy, so it is a pleasure to be part of such an engaging team. Coupled with being a PDA Ireland chapter member, I am also a member of the PDA Global Regulatory Affairs & Quality Advisory Board (RAQAB). The RAQAB mission is to serve the PDA membership by influencing scientific-based regulations and providing interpretation on quality and regulatory issues affecting development, manufacturing, and control of healthcare products. I am very excited about the future in the pharmaceutical business and the vital role that PDA will continue to play into Pharma 4.0 and beyond!

What led you to volunteer with PDA Ireland?

To connect externally and to have a voice in potential future changes affecting science and regulation business. The annual PDA events stem from what the Irish PDA members/conference attendees want to hear/learn more about/influence. PDA offers that unique industry-regulatory platform.

What significant changes have you seen in your area of expertise?

I have worked in Quality Assurance (QA) roles for the majority of my professional career. I am a Qualified Person (QP) supporting Biotech operations. The role of QA has changed from one of 'Q by Rule to Q by Example' (police versus a valued partner). Robust Quality Management Systems have revolutionised QA enabling connectivity globally and facilitating knowledge management. The advent of US EU MRA implementation and the active collaboration in 'Post Approval Change' initiatives are also bringing promise to the future in science and regulatory.

What is the best piece of advice you have ever received?

Never assume! Being in QA this nugget of information has stood to me over time!

Who would you choose to switch places with for a day?

Christine Lagarde 

Why did you become involved in PDA Ireland?

I’m a member of PDA since 2014. Initially, I joined to access the impressive range of publications available from PDA. This, of course, led to attending conferences – which were on the most topical issues & always seemed great value. Further involvement was a gradual adsorption process, encouraged by the many wise and experienced PDA members I met at these events.

What has been your most recent volunteer role?

In October 2018, I was part of the organising committee of the PDA Ireland conference on Advances in Aseptic Processing with a focus on Media Fill simulations. It was inspiring to be part of such an innovative & productive team. This year, I have been more adventurous & have volunteered to lead the team organising our Cork based conference in June on Quality Risk Management. This is a topic that I am very enthusiastic about, so it hardly seems like work!

What significant changes have you seen in your area of expertise?

I think the focus in Quality has moved from compliance to applied Quality Management, through process measurement & control. I have seen ICH Q8/9/10 evolve from a publication to an implemented control strategy. The next evolution is big data & Pharma 4.0.

What is the best piece of advice you have ever received?

Ask questions. If you are new, ask questions. If you don’t know, ask questions. If you’re investigating a problem, ask questions. If giving advice, ask questions!

Who would you choose to switch places with for a day?

The boss of Dublin Airport. I find complex logistics fascinating.

Why did you become involved in PDA Ireland?

To network with industry professionals who have a common interest in the sciences, technology and regulatory elements of the pharma industry in Ireland and indeed abroad.

What has been your most recent volunteer role?

Lead organiser for ‘Advances in Aseptic Processing with a focus on Media Fill simulations’ - Oct 18, 2018.

What led you to volunteer with PDA?

To learn more about the activities which take place in the wider pharma industry. As a project engineer with over 20 years’ experience in the pharma industry, meeting technical challenges is one of my areas of expertise and one which I continue to find exciting and creatively fulfilling. Keeping myself up-to-date on best practices nationally (and internationally) is a vital part of this work. And I have always had a grá to learn more wherever possible! So, being part of PDA, then, allows me the ideal opportunity to reach out to like-minded individuals within the industry to inform myself (and one another) about the best technologies available to meet the ever-increasing standards of the pharma world.

What significant changes have you seen in your area of expertise?

Over the last few years there has been significant changes in terms of the technological advancements now available for multipurpose aseptic filling lines for both non-potent & potent/toxic products as evidenced by the increasing oncology market sector including increased efficiency and as result increased capacity of those filling lines. I have also noted some promising developments in automatic camera inspection technology for parenterals.

What is the best piece of advice you have ever received?

As a kid growing up in Banagher Co. Offaly, the staple diet of the 1980’s consisted of hurling, hurling & more hurling! One day, one of the All-Ireland winning senior hurlers came to our U14 training session and offered this advice: “If you want to succeed at anything you need to employ the three ‘Ds’ – “Dedication, Determination & Discipline”. I have always found that quite interesting having worked for several Pharma corporations which every couple of years launch some buzz words to hopefully inspire their workforce. The three ‘Ds’ has always done it for me.

Who would you choose to switch places with for a day?

That would have to be Bill & Melina Gates – the work carried out via their world-wide charity foundation is quite inspiring i.e. using capital investments of their own and in partnership with others to benefit the greater good in developing counties around the globe. They facilitate access to life saving health products and support technical innovations in local regions that backs-up sustainable economic growth, which has knock on effect of increasing the quality of life in those areas.