From my experience attending PDA events over the last few years in Ireland, US and Europe, I knew it was something I wanted to get involved in, the events are always organized to a high standard with topical presentations.
As I only recently joined the committee, I have not done any volunteer work yet, but at the recent PDA Ireland Visual inspection event, at which I was a speaker, I got first hand experience with the team and it confirmed my decision on joining the committee.
I think the introduction of USP 1790 has been a game changer in the visual inspection area. Visual inspection is always a hot topic during audits and its nice to have this document to validate the lifecycle approach we have to visual inspection.
Over 25 years ago I had a teacher tell me to never be afraid to tell someone you don’t understand something, that nobody was born knowing everything. To this day it’s the first thing I tell someone when I’m training them on any AVI algorithm programming, don’t be afraid to stop me to go over something again.
One of my daughters, Aoife or Frankie on Christmas day. Its hard to replicate that magical experience as an adult.
My journey to becoming involved in PDA is probably not the stereotypical one! In 2017, during my final year in college, I came across a poster advertising a chance to attend the PDA European Annual Conference held in Berlin (for free!). Naturally as a student and a soon to be Microbiologist, I jumped at the opportunity. Luckily, I ended up winning this PDA Bursary Competition and have been a member ever since. Before the trip I wasn’t aware of what PDA was, I had absolutely no idea what to expect. Within minutes of my arrival, with the help of a warm welcome from PDA Ireland members I came to realise what PDA stands for. It became obvious to me that PDA is a community, a community dedicated to bringing all sides of the pharmaceutical and biotech industry together. Through out my college life I was led to believe that our industry is based on competition and being better than your competitors – which of course can be true – but what I saw in Berlin was a community of experts interacting, engaging and openly offering advice to each other. It did have a profound impact on me and my views of the industry – an industry that I wasn’t even a part of at the time!
One of the other things that struck me at this Annual Conference was the lack of “Young Professionals” in attendance. As soon as I got back to Ireland, I sent Mike Morris (president of the PDA at the time) an email outlining how I would like help to bridge the age gap and increase student & young professional participation in PDA Ireland.
As the Product & Logistics Manager at a newly formed biotech start-up, my role is still in its infancy but what I have found is that with the dramatic increase in contract manufacturing comes great responsibility. There is huge complexity in managing the quality of CMO’s and the path to successfully meeting standards can be difficult. In saying that it does provide another topic or two for the PDA to cover!
There is no such thing as a stupid question!
Aidan Costigan – a long standing PDA member and QA director that I would love to see adapt to the start-up environment!
How I would survive in Aidan’s shoes? I’m not sure – but as a person in QA all his life I’m sure he’d have it all laid out for me.
PDA Ireland have always had a strong reputation in terms of relationships with the regulators and industry experts. Having attended many worthwhile events in the past , the opportunities for engagement and networking with both the regulators and industry experts provides unique opportunities for information sharing in an open and honest environment.
The Irish industry in general has a strong regulatory compliance reputation and PDA Ireland have really worked hard to foster this and drive opportunities to be influencers of change in the Pharma industry. Having a voice within the industry was the key reason I started to volunteer. Understanding what audiences want to discuss in PDA forums and chapter meetings is a key input for a volunteer so we can ensure we are working on the correct events and documents which will interest industry subject matter experts (SMEs). Getting these SMEs engaging openly is no better avenue to help in the creation of sub-groups to drive change across multiple topics within the Pharma environment.
I have worked in many roles in Quality Assurance over the years, most recently in Quality Risk Management (QRM). The ICH Q9 guidance has been in place since 2005, however within PDA we have been exploring how we are truly getting benefit from adopting QRM principles into our Quality Management Systems (QMS). The drive to build Quality by Design (QbD) into early phases of the QMS and into projects upfront is helping to integrate QRM principles strongly into the GMP culture. Better understanding of the “how” will bring greater drive for embracing the benefits of QRM.
Don’t ever stop learning and growing as an individual
I became involved in PDA in 2006 when the Irish Chapter was founded, to assist in the launch of the chapter. Since then, I've held officer roles such as Treasurer and President-Elect.
I am a member of the chapter organising committee for the upcoming QRM seminar on June 20th in the Radisson Hotel Cork.
I enjoy the interaction with industry and regulatory personnel and believe the Irish Chapter provides its members with great learning and networking opportunities.
When I joined PDA in 2006, ICH Q9 QRM guidance was just issued, since then I have seen the industry struggling with its adoption, and the PDA conference entitled: Practical Implementation of QRM, Are we getting Value? Should give members an opportunity to discuss this.
Fortune follows the brave.
Bill Bryson, travel the world and finding humour in absurdities.
Having attended several PDA events in Europe and the US, I wanted to support PDA closer to home and see more events in Ireland.
Member of the team organising the PDA Irish Chapter Annex 1 event, May 3rd 2019.
I have used PDA Technical documents extensively for many years, and I wanted to get more involved.
With my background in Microbiology & Quality Assurance I think the most significant changes have been the introduction of Rapid Micro Methods; the increase in the use of formal Risk Management for better decision making; plus greater alignment between global regions through additional MRAs, ICH Guidance, etc.
"Use well the interval" (i.e., take advantage of the less busy times)
"Theresa May - give me 24 hours and I’ll sort it…….!"
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!
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.
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.
Never assume! Being in QA this nugget of information has stood to me over time!
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
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
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.
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!
The boss of Dublin Airport. I find complex logistics fascinating.
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.
Lead organiser for ‘Advances in Aseptic Processing with a focus on Media Fill simulations’ - Oct 18, 2018.
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.
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.
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.
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.