FDA Guidelines for Pharmaceutical Industry | FDA Regulatory 2018

  • 1295.00 Dollar US$
  • Published date: January 19, 2018
    • Chicago, IL, Chicago, IL, United States

Course "FDA Penalties for Regulatory Non-Compliance in the Pharmaceuticals Industry - 2017 in Review" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Overview:

The FDA is increasing its enforcement actions both for domestic and foreign inspections. Enforcement statistics have not been summarized yet because 2017 has not ended yet. We are certainly seeing more Warning Letters and Import Alerts based on Data Integrity (21 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 regulatory action is elevated to Import Alert, Consent Decree, and Injunctions for domestic manufacturers.
Senior Management must take the initiative in setting the tone of full compliance:
• Taking "regulatory risks" may no longer be worth the price of getting caught
• Planned deviations cannot be used as an excuse for not following your written procedures
• Retesting into compliance has been unacceptable for many years and will no longer be tolerated
• Senior officials are being held responsible. Today, these "Captains" may go down with the ship - sent to prison and fined millions of dollars
FDA's Office of Manufacturing Quality (OMQ) at the Center for Drug Evaluation and Research (CDER) evaluates compliance with current Good Manufacturing Practice (cGMP) for drugs based on inspection reports and evidence gathered by FDA investigators. The 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:
• Increased use of Contract Manufacturing Organizations (CMO) has increased the regulatory focus on CMO and requirements for Quality Agreements are being enforced
• There has been an increase in Warning Letters in 2017
• An increase in Import Alerts enforcement actions
• Data Integrity issues are being found more frequently

The Seminar:

This hands-on seminar provides a comprehensive approach to learning how to proactively prevent non-compliance. There will be intensive reviews on the negative consequences of receiving regulatory enforcement actions. FDA Warning Letters are posted publicly on the CDER web site. Your competitors, shareholders, the public and your patients now become aware of your shortfalls. Many Warning Letters today mandate the hiring of third party consultants, which can be quite expensive. An Injunction will require pharmaceutical companies to spend millions of dollars and require years until you "bounce back." Multimillion disgorgement penalties are being levied along with Injunctions.



Location: Chicago, IL Date: March 29th & 30th, 2018 and Time: 9:00 AM to 6:00 PM
Venue: Hilton Garden Inn O'Hare 2930 S. River Road Des Plaines, IL 60018
Price:
Register now and save $200. (Early Bird)
Price: $1,295.00 (Seminar Fee for One Delegate)
Until February 20, Early Bird Price: $1,295.00 From February 21 to March 27, Regular Price: $1,495.00
Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)*
Register for 10 attendees Price: $7,122.00 $12,950.00 You Save: $5,828.00 (45%)*


Contact us today!

NetZealous LLC DBA GlobalCompliancePanel
john.robinson@globalcompliancepanel.com
support@globalcompliancepanel.com
Toll free: +1-800-447-9407
Phone: +1-510-584-9661
Website: http://www.globalcompliancepanel.com

Registration Link -https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901471SEMINAR?science-marketplace-March-2018-SEO

Follow us on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel/
Like us our Facebook page: https://www.facebook.com/TrainingsAtGlobalCompliancePanel/
Follow us on Twitter: https://twitter.com/GCPanel

Result 0 votes
John Robinson
0 votes

Useful information

  • Avoid scams by acting locally or paying with PayPal
  • Never pay with Western Union, Moneygram or other anonymous payment services
  • Don't buy or sell outside of your country. Don't accept cashier cheques from outside your country
  • This site is never involved in any transaction, and does not handle payments, shipping, guarantee transactions, provide escrow services, or offer "buyer protection" or "seller certification"

Related listings

  • HIPAA Privacy, Security and Breach Notification Compliance 2017

    HIPAA Privacy, Security and Breach Notification Compliance 2017

    Training and Teaching Chicago, IL (Chicago, IL) September 21, 2017 1295.00 Dollar US$

    Overview: This session is designed to provide intensive, two-day training in HIPAA compliance, including what's new in the regulations, what's changed recently, and what needs to be addressed for compliance by covered entities and business associates...

  • Marketing, Advertising and Promotion of Pharmaceuticals and Medical Devices 2017

    Marketing, Advertising and Promotion of Pharmaceuticals and Medical Devices 2017

    Training and Teaching Chicago, IL (Chicago, IL) March 24, 2017 1295.00 Dollar US$

    The changing game for drug and device marketing, however, is governed by antiquated and inadequate rules created for traditional print and broadcast advertising by the Food and Drug Administration ("FDA"). How the FDA will deal with such advanced com...

  • Master HIPAA Compliance in Six Steps 2017 before 30 April 50% Discount for its All Seminars

    Master HIPAA Compliance in Six Steps 2017 before 30 April 50% Discount for its All Seminars

    Training and Teaching Chicago, IL (Chicago, IL) March 24, 2017 1295.00 Dollar US$

    The secret is - HIPAA Rules are easy and routine to follow - when they are explained step-by-step in plain language. In this seminar Paul Hales will capture your attention with visual presentations, discussion and learning exercises and show how to f...