Professional Development Opportunities
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Professional Development Opportunities

When considering paying for personnel to attend industry conferences & networking events, decision-makers often focus on attendance costs and ‘downtime’. They forget to consider the productivity increases and financial benefits of investing in professional development opportunities (PD events) for their employees. PD events are best viewed as an ‘uptime’ opportunity because time spent with industry…

E-Signatures on Documents in a GxP Environment – 7 Misconceptions
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E-Signatures on Documents in a GxP Environment – 7 Misconceptions

Electronic signatures (E-signatures) are becoming more and more commonly used in today’s world. Before electronic signatures were recognized and accepted legally, documents had to be manually signed by each of the signatories, stored and filed in squeaky compactors (compactus to some) held within a rather dark records room. Obviously, this process is very time consuming…

Good Documentation Practices (GDocP) | GMP Basics
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Good Documentation Practices (GDocP) | GMP Basics

GMP Basics of Good Documentation Practices (GDocP) Good documentation practice (GDocP) is a crucial component of regulatory compliance, including data integrity assurances. Referred to in the industry as Good Recordkeeping Practice (GRK), the term good documentation practice generally involves adhering to ALCOA+ principles. GRK/GDocP is mandatory to ensure that your documentation — and your products…

Good Manufacturing Practice Pens or GMP Pens – Indelible Ink
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Good Manufacturing Practice Pens or GMP Pens – Indelible Ink

Yes, we are still talking about the very old issue of Good Manufacturing Practice Pens or GMP pens and the most suitable colour of ink for pharmaceutical manufacturing pens and other issues. The various codes simply refer to “indelible ink”, as snipped from PIC/S Version 13 Good Manufacturing Practices, §4.7 Good Documentation Practices 4.7 Handwritten…