Month: July 2019

Since 1987 there has only been one major modification to the FDA’s Process Validation Guidelines, and that was in January 2011. Still viewed as a relatively “new” approach to Process Validation in the pharmaceutical, medical device, and biosimilar sectors, the fact is that these guidelines are nearing a decade old (!) and I’m not sure how well they’ve been embraced and implemented in our industry? So, what changed between 1987 and 2011? For most of us across the world we’ve seen a massive shift in how we consumed our entertainment and conducted our everyday living. VCRs, cassette tapes, land lines, libraries, etc. all became antiquated due to the advancement of technology and were quickly dominated by new means of consumption by the masses via the internet, smart phones and TVs, tablets...

Recently, some of our PACIV Puerto Rico associates completed the completed the OSHA Construction Safety Training instructed by FC Safety & Health Consulting Group, Inc. in San Juan Puerto Rico. The associates who completed the training were: Maricelys Ayala, Automation/Validation Engineer II; Jose Martinez, Sr. License Electrician; Joshua Valentin and Angel Cruz, both Automation/Validation Engineers I. The OSHA 30-Hour Construction Training is a great method for educating for workers, employers, and supervisors about OSHA safety standards. Likewise, the training included guidelines to recognize, abate, avoid, and prevent safety and health hazards at worksites through record keeping, proper material and machine handling, industrial hygiene, fall protection, and ergonomics. This...

PACIV, a PIA Affiliate Member since 2009, was present at the Pharmaceutical Industry Association (PIA) – Leadership & Innovation Summit held recently last June at La Concha Resort in San Juan. The associates who attended the event were Jean Paul Pepin, Engineering Manager and Aida Ortíz, Automation/Validation Engineer II. Under the “A Hero’s Journey” banner, the event focused on motivating current and upcoming industry leader to get actively involved in situations requiring their leadership. The event was joined by Carlos Cobian, José G. Morales known as “Gabichuela” of the Miranda Casañas Foundation, Ana M. Belaval and Graciela Eleta to discuss various perspectives and experiences to make possible innovation projects. Likewise, Esthers Alegría, PhD in Catalyst Excel &...