BEGIN:VCALENDAR
VERSION:2.0
PRODID:icalendar-ruby
CALSCALE:GREGORIAN
BEGIN:VEVENT
DTSTAMP:20240328T131540Z
UID:b6059966-ee16-496a-9a09-de55f635f9b7
DTSTART:20210201T090000
DTEND:20210202T090000
CLASS:PRIVATE
DESCRIPTION:Course &ldquo\;FDA Penalties for Regulatory Non-Compliance in t
he Pharmaceuticals Industry - 2021 in Review&ldquo\; has been Pre-approved
by RAPS as eligible for up to 12 credits towards a participant'\;s RAC
recertification upon full completion.
\n \;\n
This hands-on se minar provides a comprehensive approach to learning how to proactively pre vent non-compliance. There will be intensive reviews on the negative conse quences of receiving regulatory enforcement actions. FDA Warning Letters a re posted publicly on the CDER web site. Your competitors\, shareholders\, the public and your patients now become aware of your shortfalls. Many Wa rning Letters today mandate the hiring of third party consultants\, which can be quite expensive. An Injunction will require pharmaceutical companie s to spend millions of dollars and require years until you &ldquo\;bounce back.&rdquo\; Multimillion disgorgement penalties are being levied along w ith Injunctions. \;
\n\nThe FDA is increasing its enforcement ac tions both for domestic and foreign inspections. Enforcement statistics ha ve not been summarized yet because 2021 has not ended yet. We are certainl y seeing more Warning Letters and Import Alerts based on Data Integrity (2 1 CFR Part 11: Electronic Records\; Electronic Signatures. In the past FDA used to issue several Warning Letters to the same firms upon consecutive inspections. \; Today\, after receiving one Warning Letter the next re gulatory action is elevated to Import Alert\, Consent Decree\, and Injunct ions for domestic manufacturers.
\n\nSenior Management must take the initiative in setting the tone of full compliance:
\n\n \; &nbs p\;  \;  \;&bull\; Taking &ldquo\;regulatory risks&rdquo\; may no longer be worth the price of getting caught
\n\n \;  \; &nbs p\;  \;&bull\; Planned deviations cannot be used as an excuse for not following your written procedures
\n\n \;  \;  \;  \ ;&bull\; Retesting into compliance has been unacceptable for many years an d will no longer be tolerated
\n\n \;  \;  \;  \;&bu ll\; Senior officials are being held responsible. Today\, these &ldquo\;Ca ptains&rdquo\; may go down with the ship &ndash\; sent to prison and fined millions of dollars
\n\nFDA&rsquo\;s Office of Manufacturing Qualit y (OMQ) at the Center for Drug Evaluation and Research \; (CDER) evalu ates compliance with current Good Manufacturing Practice (cGMP) for drugs based on inspection reports and evidence gathered by FDA investigators. Th e office also develops and implements compliance policy and takes advisory actions to protect the public from adulterated drugs in the U.S. market. This year we have seen:
\n\n \;  \;  \;  \;&bull\; I ncreased use of Contract Manufacturing Organizations (CMO) has increased t he regulatory focus on CMO and requirements for Quality Agreements are bei ng enforced
\n\n \;  \;  \;  \;&bull\; There has bee n an increase in Warning Letters in 2021
\n\n \;  \;  \;  \;&bull\; An increase in Import Alerts enforcement actions
\n\n \;  \;  \;  \;&bull\; Data Integrity issues are being fo und more frequently
\n\n&bull\; \; &nb
sp\; Introduction and Background
\n&bull\; \;  \; Summary and
Highlights of 2021 Enforcement Actions
\n&bull\; \;  \; Pena
lties and Negative Financial results of Enforcement Actions
\n&bull\;
 \;  \; ICH Guidelines on Quality Risk Management
\n&bull\;&n
bsp\;  \; Adequate Responses to FDA
\n&bull\; \;  \; Chan
ge in Attitude and Culture
\n&bull\; \;  \; Metrics on Improv
ements
&bull\; \;  \; Drugm
akers
\n&bull\; \;  \; Devicemakers
\n&bull\; \; &nb
sp\; Biologics firms
\n&bull\; \;  \; Diagnostics firms
\n&bull\; \;  \; Executive suite
\n&bull\; \;  \; Man
ufacturing/GMP
\n&bull\; \;  \; QA/QC
\n&bull\; \; &
nbsp\; Regulatory affairs
\n&bull\; \;  \; Strategic planners
\n&bull\; \;  \; Legal counsel
\n&bull\; \;  \;
Consultants
This 2 Days Worksho p is intended for professionals in the \;
\n\n&bull\; \; Pha
rmaceuticals
\n&bull\; \; Biotech
\n&bull\; \; Medical D
evice
Although not presently stated in the draft \, the same gui de could be used by FDA Regulated Industries personnel.
\n\n\n SUMMARY:2 Days Workshop:FDA Penalties for Regulatory Non-Compliance in the Pharmaceuticals Industry - 2021 in Review BEGIN:VALARM ACTION:DISPLAY TRIGGER:-PT1H SUMMARY:2 Days Workshop:FDA Penalties for Regulatory Non-Compliance in the Pharmaceuticals Industry - 2021 in Review END:VALARM END:VEVENT END:VCALENDAR