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...
Read MoreProject 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...
Read MoreNew 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...
Read MoreBuilding 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...
Read MoreEU & 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...
Read MoreUnderstanding 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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