To everyone interested in or involved in GXP compliance, I am glad to say that my newest book titled, “Pragmatic GXP Compliance” has been published. It is available on Amazon at this link:
This book not a typical book on the nuts-and-bolts of GXP compliance, but one that has, as its goals:
1. EDUCATION – To help compliance practitioners teach others the importance of GXP compliance and create an enhanced culture of compliance
2. FOCUS – To provide focus on GXP compliance activities that are important and, thus, stop doing activities that provide no GXP compliance value
3. READINESS – To provide guidance on compliance and inspection readiness activities that focus on the “majors” and minimize activities that are meaningless
4. OUTCOMES – To provide tools and advice that enhance success of regulatory inspections and management of inspection outcomes
5. FUTURE – To provide perspectives and guidance on the future of regulatory inspections and activities that need to begin now
I think you will find nuggets of value in this work that will make it highly value-added as you seek to balance the need to fully comply with GXP requirements, yet do so efficiently.
A Kindle version should be available soon.