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Blog

UPDATE: Second Stakeholders' Consultation on the Revision of Annex 1

By John Henchion, February 21, 2020

The second targeted stakeholders' consultation on the revision of Annex 1, on the manufacturing of sterile medicinal products, of Eudralex Volume 4

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Quick Glance: ICH Q10 Question Solved?

By John Henchion, February 13, 2020

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Quick Glance: Regulatory and Inspection Harmonization

By John Henchion, February 6, 2020

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Relationship Management: Why, Who, & How

By Melissa Austin, December 19, 2019

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Louder Than Words: The Key to Effective Communication

By John Krawczyk, 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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Project Meetings Playbook: Your Map to Meeting Nirvana

By Melissa Austin, 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.

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New PDA Resource: 2019 Technology Transfer Industry Survey

By Beth Haas, 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

By Chip Bennett, 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!

By John Henchion, 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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Understanding cGMPs for Phase 1 Investigational Drugs

By Dan Carpentio, 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 a unique situation in which the requirements of 21 CFR 211 in the manufacture of a drug are exempt.  That is for the manufacture of Phase 1 investigational drugs.

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How to Understand ASTM E2500