Louder Than Words: The Key to Effective Communication
It is a well-established maxim that "Good communication is the key to successful projects." Clear, concise, specific communication is the goal, and this applies to...
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Project Meetings Playbook: Your Map to Meeting Nirvana
Project Team Meetings are rarely identified as a risk event for a project’s success. Yet, non-productivity during these collaboration sessions is highly probable and can...
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New PDA Resource: 2019 Technology Transfer Industry Survey
Results from the PDA survey on Technology Transfer have now been published documenting key highlights and findings from the participant response! This publication which was...
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Building Trust – Engineering to Quality/Validation
Over the years, the roles and responsibilities of Engineering and Quality/Validation have evolved for Commissioning and Qualification (C&Q) activities. Now more than ever, risk-based approaches...
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EU & US MRA Fully Operational – What You Need to Know!
Background In 1998, the EU and the US signed a broad Mutual Recognition Agreement (MRA), which included a Pharmaceutical Annex providing for anticipated and limited...
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Understanding cGMPs for Phase 1 Investigational Drugs
Everyone in the pharmaceutical manufacturing industry understands or has at least heard of current Good Manufacturing Practices (cGMP). The requirements of the cGMPs are prescribed...
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Release of 2nd Edition ISPE Baseline Guide 5 for C&Q
Intro ISPE has just released the second edition of Baseline Guide 5 for Commissioning and Qualification (C&Q) The objective of the 2019 C&Q Baseline Guide...
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FDA Approves Emergency IND in Less Than Three Hours
How a CAI agent helped make a difference (more…)
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