June SmarterCompliance Newsletter Available

The June issue of my SmarterCompliance^tm newsletter is now available.  Topics include:

• Analysis of the FDA's five year PDUFA IV plan
• Step-by-step guide to creating an FDA records discovery strategy
• FDA enforcement review of warning letters on supplier audits
• How to comply with the biosample retention requirements
• Boosting employee buy-in of policies and SOPs
• and more....

Subscriber downloads include:

• FDA's PDUFA IV Five-Year Plan
• EMEA Guidance:  ICH Q8, Q9, Q10 Frequently Asked Questions
• EMEA Guidance:  GCP Inspection Coordination
• Sedona Principles on E-Discovery
• Sedona Commentary on Records Litigation Holds

You can get my monthly newsletter by subscribing here:   http://www.ceruleanllc.com/Newsletter/Subscribe.htm

And if you're not sure if you want to subscribe, I do offer free 6-month trial subscriptions with my executive quick-start pack.  Alternatively, if you sign up for my mailing list at Cerulean, I'll be happy to send one issue free so you can decide if you want the trial or want to jump right in and start getting smarter about compliance.

Details on the executive quick-start kit are here:  http://www.ceruleanllc.com/Toolkit/QuickStartKit.htm

And you can join my Cerulean mailing list here:  http://www.ceruleanllc.com/ContactReq.aspx 

As always, give me a shout with questions....