Quality Culture and Young Professionals Event Held at Sanofi, Waterford
Dr Katrin Winkler (left) delivers her presentation on how culture and behaviours drive organisations at the PDA YP event in Sanofi Waterford on November 14th, 2018
5 Takeaway points for the Event
- Quality and excellence are values relevant in all parts of the business - from engineering to process improvement and project management
- The essence of a culture of quality and excellence is shaped by people and leadership
- A culture of control and regulation will not instil quality and excellence
- Strategy and Guidelines can create a framework of quality and excellence
- Engagement in quality and excellence is not a one day endeavour but a continuous journey
Advances in Aseptic Processing with a Focus on Media Fill Simulations Event Summary
On October 4th, over 90 registered delegates attended the PDA Ireland Chapter “Advances in Aseptic processing with a focus on Media Fill simulations”. This event was hosted at the Clayton Hotel Dublin Airport. This event was emceed by Catherine McHugh, PAREXEL Consulting.
The following topics presented during the morning session:
- “Updates to Annex 1 and issues with Training of Operators” presented by Greg McGurk, Regeneron,
- “Proficiency-based Progression Training” presented by Tony Gallagher, UCC
- “Principles of Good Learning Design” presented by Emmett Cullinan, Sanofi
- “Expectations for an Aseptic Manufacturing Qualification Program” presented by Valerie Mulholland, GMP Services.
The early afternoon session focused on
- “Isolator Glove Management” presented by Aidan Harrington, DPS Group
- “The Future of Aseptic Processing” presented by Marco Delgado Rueda, PAREXEL Consulting.
During the afternoon session, the attendees were split into smaller groups for round table discussions. This proved to be a more engaging and interactive format for peer-to-peer learning. The topics discussed were:
- Process simulation
- Contamination Control strategies
- Annex 1
- and Visual Inspections
The topics presented stimulated a significant amount of discussion and the outcome of the discussions positively reached a wide audience.
- Appropriate knowledge and preparation for Annex 1
- Identifying issues with Training Employees
- Supervisors role when training team members
- Completing an operation to proficiency
- Identifying realistic training time frame
2018 Student Bursary Winner, Shane Murphy reflects on the PDA EU 3rd Annual Meeting
Along with Aiofe Clancy, I was also granted the opportunity to attend the Parenteral Drug Association Europe (PDA EU) 3rd Annual Meeting. Initially, I was nervous and unsure what to expect from my first PDA Meeting. However, my nerves were soon replaced with excitement when I meet the PDA Ireland Chapter officers and PDA EU staff members.
I thoroughly enjoyed the topic discussed during Session 3 Track B –
"Why Better Human Understanding is the Only Future" presented by Craig Scott, Greensand. The presentation highlighted the importance of prioritizing the human element of resolving the customers’ needs above all other variables.
The other speaker presentations broadened my knowledge of current advancements in the industry, guided my awareness to resolve potential flaws in a system, and create innovative ideas to continuously develop the industry
During the lunch breaks, I was grateful to connect with professionals in the industry who provided more insight on their career experiences.
The topics I learned at the EU Annual Meeting will be applied to my future career in Microbiology. I intend to focus my career within the Disease, Diagnostics, and Immunology sector.
I would highly recommend other university students to apply to the next Student Bursary program hosted by the PDA Ireland Chapter and PDA Europe staff members.
2018 Bursary Winner - Aoife Clancy shares PDA EU Annual experience
This June, I was fortunate enough to be awarded a Student Bursary from the Parenteral Drug Association Irish Chapter. The Bursary Award provided me with an opportunity to attend the PDA 3rd Annual Meeting in Berlin. I was extremely excited to attend the event and learn about the current demands within the global healthcare industry and advanced technologies and opportunities within the pharmaceutical industry.
I was welcomed warmly on the first day of the conference by the members of the Irish Chapter. They introduced me to their colleagues and other conference attendees, and I learned about the roles which they assumed in their respective companies.
The theme of the meeting, Global Healthcare of the Present and Future, was of great interest to me, given my background in Pharmacy. The meeting consisted of presentations from regulatory, industry and technology representatives from around the world. Since a lot of my experience comes from patient-facing roles, the talks on Patient Perspectives, personalised medicines and patient centricity appealed to me greatly. The Young Professionals Session of Day 2 was definitely a highlight of the meeting. Cristoph Marschall, who also completed an undergraduate degree in Pharmacy, presented on Protein Powder Suspensions and their viability as an alternative to conventional formulations. Cristoph spoke about problems associated with proteins due to their potential to aggregate, causing conformational changes. He discussed the issue of viscosity with non-aqueous formulations, which can present challenges during the injection process. I could really connect with this topic, having completed relevant modules during my time in Trinity College. Finally, the Multi Organ Chip Technologies presentation by Reyk Horland was very inspiring. It was exciting to hear about the ways in which safety and efficacy data can be generated much earlier in the drug development timeline.
To compliment the fantastic presentations at the meeting, the networking event on the first night afforded me with a memorable tour of Berlin via the channels of the city. We embarked on a cruise through the city - a very novel way to see the sights. This is a memory I will never forget.
I would like to extend my sincere thanks to PDA Ireland for awarding me the Student Bursary and providing me the amazing opportunity to attend the European Annual Meeting. I learned so much, met so many incredible people, networked and found career inspiration.
PDA Ireland announce Bursary Winners
In partnership with PDA Europe, we have continued our commitment to provide educational development opportunities for students by producing our 2nd Bursary.
This year, we accepted applications to third level students (undergraduate and postgraduate). The bursary included a free ticket to the PDA Annual Meeting on 26 - 27 June 2018 in Berlin and 800 euro towards travel expenses and accommodation.
We are proud to announce the names of our 2018 Bursary recipients: Shane Murphy and Aoife Clancy.
Shane Murphy is currently studying Bioanalysis at the Institute of Technology in Tallaght (Dublin), Ireland. In September, Shane will return to college to complete his Bachelor Honours Degree. "I entered the bursary as I wanted to expand my knowledge of the Pharmaceutical industry, and see first hand the new innovative ideas and techniques used today."The bursary also provides young scientists like myself a chance to network and network with like-minded individuals.
I am in currently living in Germany for a research internship studying Bone Regeneration and Extracellular vesicles as diagnostic markers in Leipzig, East Germany. I'm really looking forward to traveling to Berlin and attending the PDA conference.
Aoife Clancy recently completed her final year exams in Trinity College Dublin and will graduate with a First Class Honours B.Sc.(Pharmacy) degree. Aoife is currently working with a summer research internship position at Trinity and will commence her Masters in Pharmacy placement in St. James's Hospital in September.
Over the last four years, I have spent my time gaining experience in both the hospital and community pharmacy settings, enhancing my clinical knowledge. My time in hospital pharmacy heightened my interest in biological medicines, sterile manufacturing, and continuity of supply (following the pipericillin-tazobactam shortage of 2016).