Blog

Louder Than Words: The Key to Effective Communication

November 26, 2019 ||
 
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 business as well as day-to-day life. The trouble is following through on it.
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New PDA Resource: 2019 Technology Transfer Industry Survey

September 9, 2019 ||
 
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 co-authored by one of CAI’s principal consultants, Beth Haas, can be found in the PDA Bookstore.  Learn more about Beth below.
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Building Trust – Engineering to Quality/Validation

September 6, 2019 ||
 
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 rely heavily on Engineering Subject Matter Experts (SMEs) and the application of Good Engineering Practices (GEPs) as an Engineering Quality Process to underpin C&Q.
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EU & US MRA Fully Operational – What You Need to Know!

July 25, 2019 ||
 
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 reliance on each other’s Good Manufacturing Practice (GMP) inspections. However, this Agreement was never fully implemented.
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“The ultimate goal of providing a robust, safe method to transfer solutions in the Manufacturing Facility was achieved and CAI played a major role with this safety initiative.”

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