Relationship Management: Why, Who, & How
December 19, 2019 ||
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.
Project Meetings Playbook: Your Map to Meeting Nirvana
October 22, 2019 ||
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 be very costly.
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.
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.
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.
Understanding cGMPs for Phase 1 Investigational Drugs
July 18, 2019 ||
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 in Title 21 of the Code of Federal Regulations parts 210 and 211 (better known as 21 CFR part 210 and 211). But there is…
Release of 2nd Edition ISPE Baseline Guide 5 for C&Q
July 16, 2019 ||
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 revision is to define and explain a simplified risk-based C&Q process in a single guide that meets present-day standards and provide focus to ensure a…
FDA Approves Emergency IND in Less Than Three Hours
June 27, 2019 ||
How a CAI agent helped make a difference
How to Measure PQS Effectiveness Using the CAPA System
June 25, 2019 ||
A ICH Q10 Challenge