Former FDA Officials to Conduct ComplianceOnline Seminar on Handling FDA Inspections
ComplianceOnline, the leading GRC advisory network, and former FDA officials Martina LaGrange and Shelly Maifarth will conduct a two day seminar on how to prepare for and meet the FDA inspections.
- (1888PressRelease) June 15, 2013 - Palo Alto, CA, USA - ComplianceOnline, the leading governance, risk and compliance advisory network with over 500 experts in various regulatory subjects, today announced a seminar Why is FDA at my facility, and what do I do during an inspection? The two day in-person seminar by former FDA Medical Device Specialist Ms. Martina LaGrange and former FDA Compliance Officer Ms. Shelly Maifarth will be held on September 26 - 27, 2013 at Boston, MA.
Meeting the FDA expectations 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 will help organizations to prepare for quick, productive and effective FDA inspections.
For more information or to register for the seminar, please click here.
Seminar Instructors Martina LaGrange and Shelly Maifarth are former FDA employees and currently working as the principals at FDA Compliance Group LLC.
Ms. LaGrange began her 14 years of career with the FDA as a field investigator and retired as a Medical Device Specialist. She performed medical device, dietary supplement, pharmaceutical and clinical investigator inspections both domestically and internationally. 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 FDA inspections seminar, instructors will discuss why the FDA conducts inspections and the sanctions available to the FDA for those companies who choose not to comply with FDA requirements. They will also cover do's and don'ts during inspections, choosing your core inspection team and facilitators and how to prepare your subject matter experts (SMEs) to respond properly. This course will provide attendees an understanding on what to expect during the FDA inspections, 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 and this is one of the most popular ComplianceOnline training sessions.
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 Subject Matter Experts (SMEs).
Date: Thursday, September 26, 8.00 AM - 4.30 PM and Friday, September 27, 2013, 8.30 AM - 4PM EDT
Location: Boston, MA
Registration Cost: $1,899.00 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 ( @ ) complianceonline dot com
For more information on ComplianceOnline or to browse through our trainings, please visit our website .
About ComplianceOnline
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
ComplianceOnline
2600 E Bayshore Rd
Palo Alto CA USA 94303
650-620-3937 phone
650-963-2530 fax
reuben ( @ ) complianceonline dot com
http://www.complianceonline.com
http://www.complianceonline.com/ecommerce/control/seminar?product_id=80075SEM&channel=PR_June 14
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