▪ It was great to catch up with old friends and colleagues, seeing them now in these positions of influence, hugely successful careers, taking ownership, protecting our two-legged and four-legged public.
▪ It was great to connect with FDA in this relaxed setting - instead of during an inspection or regulatory meeting! 😉
▪ It was also great to meet folks for the first time! The networking opportunities were great, though I did miss quite a few of you!
A few take-aways:
🔹 Basic, fundamental GMP issues continue to be seen by FDA across the industry, despite the tools, technology, resources, policy, guidance documents, history of observations, warning letters and enforcement, training, industry groups.
🔹 Bare feet in an ISO-classified suite?!?!
🔹 FDA’s Top Ten Issues cited in 483s have not really changed over 20+ years; rankings have shifted up or down, but it is still the same things
🔹 Similarly, DI (data integrity) is not a new concept. As Dr. Cavazonni said, “Get away from paper.”
🔹 “Reading an SOP is not training” – Alonza Cruse
🔹 “The battle is won and lost at the Supervisor level” – Kevin O’Donnell, (HPRA)
🔹 Have we forgotten about the patient? Have we forgotten who the patient is? Do we not realize we are The Patient?
🔹 “Cost of Quality” Why do we use this term? Why don’t we ever speak of the Cost of HR? The Cost of Supply Chain? of Technical Services?
🔹 Leadership sets the tone: it is the determiner of success.
🔹 Leadership is responsible for issues – whether they know it, or not.
🔹 Training, training, training. Real, intentional, training. Designing your org to be effective over the product life cycle should be your goal, not just for the next quarter’s results.
Isn’t there a company out there that can help with this?
🔷 Eliquent – from thought to finish 🔷
Christie Bielinski; Karin Baer; Ileana Barreto-Pettit; Linda Evans O'connor;William (Al) Kentrup; Gerard (Jerry) Greco; Donald Ashley; Grace McNally ; Barbara Clendenen; Carmen C. Araujo; Elaine Shannon; Magaly Aham, MSc, RAC-US; Christina M. Mazzella; Domenic Veneziano; Sumaiya Reza; Zhenzhen Liu; Arlene Wolny; Arie Menachem; Saundrea Munroe; Jerome Chal; Maria McCaffrey; Cathy Burgess; Beth Weinman; Greg Levine ; Darrin Schellin; Brendan Carroll; Ben Wolf; Anthony Fanucci, PharmD, JD; Quality & Regulatory Network; Alonza Cruse; Michelle Toro, ASQ CQA, CSQP; Judy Zdanowicz; ELIQUENT Life Sciences; Eliquent Japan, Inc; Eli Shani; Ori Landau; Kimberly Garko; Jenna McCarthy
Members of the ELIQUENT Life Sciences team - Donald Ashley, Grace McNally, and Joseph Jimenez - will be at this week's annual PDA-FDA Joint Regulatory Conference. Stop by our booth and learn more about ELIQUENT's unique platform delivering full-service support for life science innovators. ELIQUENT.com
