ComplianceOnline

Course "FDA Penalties for Non-Compliance in Pharma - 2017 case studies and Readiness for 2018" has been pre-approved by RAPS as eligible for up to 10 credits towards a participant's RAC recertification upon full completion.

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.

Topic Background:

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.

Seminar Fee Includes:
Lunch
AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar

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
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
Day 01(8:30 AM - 4:00 PM)
  • 08.30 AM - 09.00 AM: Registration
  • 09.00 AM: Session Start
  • Lecture 1: Introduction and Background
    • Introductions / Participants’ Understanding / Participants’ Objectives for the Course (Please come prepared to discuss)
    • Background
    • Industry Context
    • Key Concepts
  • Lecture 2: Summary and Highlights of 2017 Enforcement Actions
    • Warning Letters
    • Import Alerts
    • Consent Decrees
    • Injunctions
  • Lecture 3: Penalties and Negative Financial results of Enforcement Actions
    • Detailed Costs and Expenditures for Remediation
    • Loss of Sales and Customers
    • Decreases in Patients Access
    • Loss of Good Reputation
    • Loss of Jobs
  • Lecture 4: ICH Guidelines on Quality Risk Management
    • Science Based Quality Risk Management
    • Quality Risk Management Process
    • Initial Risk Assessment
    • Implement & Verify Appropriate Controls
    • Review Risks & Monitor Controls
Day 02(8:30 AM - 4:00 PM)
  • Lecture 5: Adequate Responses to FDA
    • Comprehensive Corrective and Preventative Action (CAPA) Plans
    • Sincere and Specific timelines
    • Quarterly Follow-ups
    • Adequate but not overwhelming documentation
    • Training
  • Lecture 6: Change in Attitude and Culture
    • Full Support and Commitment of Senior Management
    • Responsibilities to Customers
    • Proactive Not Reactive
  • Lecture 7: Metrics on Improvements
    • Management Involvement
    • Personnel Involvement
    • Positive Increases in Metrics Lead to Positive Attitudes
    • Incentives and Acknowledgements
  • Interactive Session: Group Activities Writing FDA-483 Responses
    • Instructors Evaluation and Recommendations
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Brian G. Nadel

Brian G. Nadel
President, Brian G. Nadel, GMP Consulting, LLC

Brian G. Nadel is the President/Sole Proprietor of Brian G. Nadel, GMP Consulting, LLC. He has over twenty-five years of diverse experience in: Pharmaceutical Quality Assurance and Quality Systems; FDA Pre-Approval and Inspection Readiness Inspections; International CGMP Auditing for finished drug products, Active Pharmaceutical Ingredients, Fermentation, Process Validation and botanical extraction.

Mr. Nadel utilizes his broad background to assess compliance issues and develop effective, efficient comprehensive systems to ensure CGMP Compliance. He assists pharmaceutical firms in maintaining and developing quality manufacturing operations. He has worked with NDA, ANDA, DMF, BLA and OTC product manufacturers. He has also conducted CGMP training for FDA, Industry and at industry conferences. He has worked to assist clients to comply with the requirements of Consent Decrees. He has used his experience in the pharmaceutical and government regulatory industries to author SOPs in quality and compliance areas.

Mr. Nadel holds a BA in Microbiology and Parasitology from the State University of New York at Albany, NY and is a certified Regulatory Affairs Professional. He is a member of the Parenteral Drug Association and the Regulatory Affairs Professional Society. Mr. Nadel has spoken at many industry conferences, including three conferences in India in 2017.

Mr. Nadel has just completed his third trip to India in 2017. During these visits, he has been working with Indian Pharma to train them to proactively prevent problems and respond to “issues” with the US FDA.

Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

Register Now

Online using Credit card

$1,299.00

Seminar One Registration

February 26-27, 2018, Orlando, FL




Early bird seats are limited and based on first-come, first-serve.

Your registration fee includes the workshop, all course materials and lunch.


For discounts on multiple registrations, contact customer care at +1-888-717-2436.

Other Registration Option

By order form / PO#

Payment Mode

By Check -
Pay your check to (payee name) “MetricStream Inc” our parent company and Mail the check to:

ComplianceOnline (MetricStream, Inc),
2479 East Bayshore Road Suite 260
Palo Alto, CA 94303
USA

By Wire -

Register / Pay by Wire Transfer

Please contact us at +1-888-717-2436 to get details of wire transfer option.

Terms & Conditions to Register for the Seminar/Conference/Event

Your registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-717-2436 or email us @ customercare@complianceonline.com

Payment:
Payment is required 2 days before the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. (our parent company).

Cancellations and substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund - less a $300 administration fee. No cancellations will be accepted - nor refunds issued - within 10 calendar days before the start date of the event.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($300) will be transferred to any future ComplianceOnline event and a credit note will be issued.

Substitutions may be made at any time. No-shows will be charged the full amount.

We discourage onsite registrations, however if you wish to register onsite, payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available, we will send the material after the conference is over.

In the event ComplianceOnline cancels the seminar, ComplianceOnline is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.

Attendance confirmation and documents to carry to the seminar venue:
After we receive the payment from the registered attendee, an electronic event pass will be sent to the email address associated with the registrant 5 working days before the seminar date. Please bring the pass to the venue of the event.

Conference photograph / video:
By registering and attending ComplianceOnline conference, you agree to have your photographs or videos taken at the conference venue and you do not have any objections to ComplianceOnline using these photos and videos for marketing, archiving or any other conference related activities. You agree to release ComplianceOnline from any kind of claims arising out of copyright or privacy violations.

Location:

Orlando, FL
(Venue to be announced shortly)

February 26-27, 2018

Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

We are pleased to offer several exhibitor, sponsorship and media partnership options designed to maximize your company's exposure and networking opportunities before, during and after the event.

Benefits of becoming a Sponsor/Exhibitor/Media Partner:

  • Logo on website, marketing email, branding materials & the registration booth
  • Exhibit Space
  • Free event pass
  • Speaking opportunity
  • Social media campaign

For more details and other sponsorship options at this event, please contact Event Manager: customercare@complianceonline.com or call: +1-650-238-9656

Media Partner:

Media Partner

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