For the first time, FDA officials can detain drug products they believe are adulterated or misbranded.
They can detain the drug for up to 20 days, and a drug importer has just 5 days to appeal the detention
order after receiving it.
Plus, FDASIA allows the agency to register importers and directs it to establish Good Importer
Plus, FDASIA allows the agency to register importers and directs it to establish Good Importer
Practice (GIP) regulations.
We’ve invited John Taylor III, Counselor to the Commissioner and Acting Deputy Commissioner for Global Regulatory Operations and Policy at FDA to provide details.
The last few months have seen a sharp increase in FDA’s enforcement powers: the ability to detain
We’ve invited John Taylor III, Counselor to the Commissioner and Acting Deputy Commissioner for Global Regulatory Operations and Policy at FDA to provide details.
The last few months have seen a sharp increase in FDA’s enforcement powers: the ability to detain
drug products at the border, allowing investigators to take photos in your facility without your approval
and new registration requirements.
Coupled with increasingly LONG and very DETAILED Form 483s and Warning Letters, it’s enough to
Coupled with increasingly LONG and very DETAILED Form 483s and Warning Letters, it’s enough to
make any quality or compliance professional a little nervous.
Today’s inspectors are a breed unto themselves — many have worked in industry and know where
Today’s inspectors are a breed unto themselves — many have worked in industry and know where
traps are hiding in your plant or its documentation. They are highly educated, clear-headed and are
well trained to look into every aspect of your operations.
Take a rare opportunity to pick FDA investigators’ brains – how they think and what they look for.
Take a rare opportunity to pick FDA investigators’ brains – how they think and what they look for.
Learn secrets of proving your outsourcing oversight works. Find out what’s just down the FDASIA pike.
Take a sneak peek below at top-notch speakers.
FDA Speakers Include:
John Taylor III, Counselor to the Commissioner and Acting Deputy Commissioner for Global
FDA Speakers Include:
John Taylor III, Counselor to the Commissioner and Acting Deputy Commissioner for Global
Regulatory Operations and Policy, OC, FDA (invited)
David Glasgow, Director, Division of Domestic Field Investigations, ORA, FDA (invited)
Diane Amador Toro, District Director, ORA, FDA, Parsippany District
Elizabeth Dickinson, Chief Counsel, OC, FDA (invited)
Rick Friedman, Associate Director, Office of Manufacturing & Product Quality, CDER, FDA (invited)
Brian Hasselbalch, Acting Associate Director, Policy and Communication, OMPQ CDER, FDA (invited)
Grace McNally, Senior Policy Advisor, OC, CDER, FDA (invited)
Dr. Leslie Ball, Assistant Commissioner for International Programs, Deputy Director, Office of International Programs, Office of Global Regulatory Operations and Policy, ORA, FDA
Kimberly Trautman, Associate Director, International Affairs, Medical Device International Quality Systems Expert, Office of the Center Director, CDRH, FDA (invited)
Lori Lawless, SCSO, Medical Device Specialist, ORA, FDA, Baltimore District
Rachel Harrington, CSO, Drug Specialist, ORA, FDA, Baltimore District
Erin McFiren, CSO, Medical Device Specialist, ORA, FDA, Baltimore District
Former FDA Speakers Include:
Elaine Messa, Executive Vice President of the Medical Device Practice, Becker & Associates Consulting;
David Glasgow, Director, Division of Domestic Field Investigations, ORA, FDA (invited)
Diane Amador Toro, District Director, ORA, FDA, Parsippany District
Elizabeth Dickinson, Chief Counsel, OC, FDA (invited)
Rick Friedman, Associate Director, Office of Manufacturing & Product Quality, CDER, FDA (invited)
Brian Hasselbalch, Acting Associate Director, Policy and Communication, OMPQ CDER, FDA (invited)
Grace McNally, Senior Policy Advisor, OC, CDER, FDA (invited)
Dr. Leslie Ball, Assistant Commissioner for International Programs, Deputy Director, Office of International Programs, Office of Global Regulatory Operations and Policy, ORA, FDA
Kimberly Trautman, Associate Director, International Affairs, Medical Device International Quality Systems Expert, Office of the Center Director, CDRH, FDA (invited)
Lori Lawless, SCSO, Medical Device Specialist, ORA, FDA, Baltimore District
Rachel Harrington, CSO, Drug Specialist, ORA, FDA, Baltimore District
Erin McFiren, CSO, Medical Device Specialist, ORA, FDA, Baltimore District
Former FDA Speakers Include:
Elaine Messa, Executive Vice President of the Medical Device Practice, Becker & Associates Consulting;
former Director of the Los Angeles District, FDA
Larry Spears, Director, Deloitte & Touche LLP, former Deputy Director for Regulatory Affairs at CDRH, FDA
David Chesney, Vice President and Practice Lead, Strategic Compliance Services, PAREXEL
David Chesney, Vice President and Practice Lead, Strategic Compliance Services, PAREXEL
Consulting; former FDA District Director for the San Francisco office
Tim Wells, President, QualityHub; former Team Leader for the QSIT Project, CDRH, FDA
e Inc.
Speakers Include:
Barbara Immel, President, Immel Resource LLC (Chairperson)
Frederick Branding, Principal, Olsson Frank & Weeda
Gilda D’Incerti, CEO, Pharma Quality Europe
John Avellanet, Managing Director & Principal, Cerulean Associates LLC
Marie McDonald, Senior Director, Quality & Compliance Consulting, Quintiles
Connie Hoy, Vice President, Global Regulatory Affairs, Palomar Medical Technologies
Dr. Ibim Tariah, Technical Director, BSI Healthcare Solutions
View Speaker Bios
Tim Wells, President, QualityHub; former Team Leader for the QSIT Project, CDRH, FDA
e Inc.
Speakers Include:
Barbara Immel, President, Immel Resource LLC (Chairperson)
Frederick Branding, Principal, Olsson Frank & Weeda
Gilda D’Incerti, CEO, Pharma Quality Europe
John Avellanet, Managing Director & Principal, Cerulean Associates LLC
Marie McDonald, Senior Director, Quality & Compliance Consulting, Quintiles
Connie Hoy, Vice President, Global Regulatory Affairs, Palomar Medical Technologies
Dr. Ibim Tariah, Technical Director, BSI Healthcare Solutions
View Speaker Bios
No comments:
Post a Comment