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Educating GMP laboratory analysts on good laboratory practices (GLP) goes a long way in reducing staff resistance to incorporating GLPs into GMP lab operations, according to Kristin Arpin, a quality assurance expert with Purdue Pharma.
A key goal of GMP training is to bring employees up to a satisfactory level of competence that can be proven to FDA inspectors, according to David Markovitz, president and founder of GMP Training Systems. Read More
Enterprise resource planning (ERP) systems can benefit FDA-regulated companies but their complexity and regulatory challenges can derail a company’s efforts, says ERP expert Bill Fitch.
Too many FDA-regulated life science companies mistakenly believe that writing and posting a good erecord compliance program is enough, experts stressed at recent events.
Drug and device companies risk losing out on the competitive and regulatory advantages of electronic data capture (EDC) by failing to address their own corporate cultures, skimming over training efforts and failing to set clear goals before attempting to implement a program, experts told PIR last week.
With employee training now playing such a critical role in manufacturing efforts, drugmakers like Novartis have started turning to learning management systems (LMS) to manage the delivery of critical regulatory and corporate policies to their employees.
In light of the time and money required to conduct GMP training sessions, it is crucial that employers take every step possible to ensure training efforts are retained and carried into the workplace, according to training expert David Markovitz, founder and president of the Institute for Effective Innovation.