At the conclusion of the session, participants will receive:
Management and professionals responsible for conducting or participating in quality systems management reviews, including individuals from quality, compliance, regulatory affairs, legal, and executive management teams.
John Avellanet is co-founder of Cerulean Associates LLC, an FDA management advisory firm that specializes in helping companies implement compliant, lean, cost-effective FDA and ICH quality systems and records management programs. Previously, he spent more than 15 years being accountable for regulatory compliance, most recently as a C-level executive for a Fortune 50 biotechnology and medical device subsidiary, during which time he was responsible for designing and putting in place ICH, FDA, and ISO compliance programs. He serves on the advisory boards of several trade associations, and has conducted dozens of speeches, workshops and training seminars on FDA quality systems and records management compliance.
If you have questions about this teleconference and its appropriateness to your company, Mr. Avellanet can be contacted directly through his private firm’s website, www.Ceruleanllc.com, his blog, www.ComplianceZen.com, or by email at john@ceruleanllc.com.
Each toll-free (even if international) dial in is $449; put the teleconference on your speakerphone and have as many attendees as you like for this price. FOI Services will provide a handout of about 50 pages approximately two days before the teleconference. The materials may be duplicated for anyone attending.
Tuesday, July 21, 2009, from 1:00 p.m. to 2:30 p.m. EDT (GMT -4)
In your office or conference room
To register online, or for details on additional upcoming teleconferences, go to www.foiservices.com/tc. You may also call 1-800-654-1147 (outside the US and Canada call +1-301-975-9400) to register by phone.