Meeting the FDA expectation on audits and inspections is the greatest challenge to most of the FDA regulated companies. This two day in-person seminar by former FDA investigators (http://www.complianceonline.com/
For more information or to register for the seminar, please Click here.
Seminar instructors LaGrange and Shelly Maifarth are former FDA officials and are currently the principals at FDA Compliance Group LLC.
Martina LaGrange began her 14 years of career with FDA as a field investigator and retired as a Medical Device Specialist. She inspected some of the world's largest manufacturers, with 75% of inspections resulting in the issuance of a Warning Letter. Ms. Maifarth began her career with FDA as an investigator and microbiologist and then served as an FDA Compliance Officer for more than 22 years. As a Senior Compliance Officer, Ms. Maifarth successfully completed numerous regulatory actions such as warning letters, seizures, injunctions, prosecutions, inspection warrants, license suspensions and revocations to bring firms and products into compliance.
During the two day long FDA inspections seminar, the instructors will discuss why the FDA conducts inspections and the sanctions available to FDA for those companies who choose not to comply with FDA requirements. They will also cover dos and don’ts, how to choose the core inspection team, facilitators, Subject Matter Experts (SME’s), runners and scribes. This course will provide the attendees an understanding on what to expect during the FDA inspection, including how to communicate with the investigators, how to run front and back rooms, and present documents and records. This two day interactive workshop includes the real life inspection scenarios/case studies.
The seminar will be valuable for any regulatory personnel in FDA regulated medical device, pharmaceutical, food and dietary and med tech industries who handles functions involving top and middle management, quality assurance/management, compliance management, manufacturing, laboratory and SMEs.
Date: Thursday, February 7 and Friday, February 8, 2013, 8 AM-4 PM PST
Location: San Diego, CA
Registration Cost: $1,699.00 per registration
Early bird discounts: For discounts on early registrations, please click here.
Register by phone: Please call our customer service specialists at +1-650-620-3937 or email to customercare@
For more information on ComplianceOnline or to browse through our trainings, please visit our website
ComplianceOnline is a leading provider of regulatory/compliance trainings for companies and professionals in regulated industries. ComplianceOnline has successfully trained over 20,000 professionals from 3,000 companies to comply with the requirements of regulatory agencies. ComplianceOnline is headquartered in Palo Alto, California and can be reached at http://www.complianceonline.com/?
For more information please contact:
A Reuben Bernard
Manager of Program Marketing
2600 E Bayshore Rd
Palo Alto CA USA 94303