ComplianceOnline

This course will cover all aspects of FDA regulation of Over the Counter (OTC) pharmaceuticals. The FDA requirements for marketing a product OTC will be explained. Compliance with OTC monographs, products that start out as prescription drugs and then are switched to OTC, and products that start out as OTC drugs will be discussed. How to market each type will also be covered. FDA requirements for the ingredients in and labeling of OTC products will be considered. How frequently to expect FDA inspections, how to handle FDA inspections and how to avoid FDA Enforcement Actions will also be covered.

Learning Objectives:

After completing this seminar, you will gain a better understanding of how to:

  • Develop an OTC Drug
  • Comply with an OTC Monograph
  • Propose an addition to an OTC Monograph
  • Obtain approval for Rx to OTC switch products
  • Obtain approval for de novo OTC products
  • Avoid FDA enforcement actions
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

Areas Covered:

  • The areas that will be discussed in the seminar will include the following topics throughout the agenda:
  • OTC Drug Review Process
  • OTC Drug Monographs
  • Status of specific OTC Monographs, their included Regulatory Requirements and Strategies for Commercialization
  • Rx to OTC Switches
  • Direct to OTC NDAs
  • OTC Drug Ingredients
  • Marketing a drug product that deviates from a final monograph
  • OTC Drug Labels, Labeling, Marketing and Advertising Issues
  • FDA Enforcement Actions

Who will Benefit:

  • Pharmaceutical Research and Development Supervisors
  • Management Representatives who select new pharmaceutical products to develop
  • Pharmaceutical Regulatory Affairs personnel
  • Pharmaceutical labeling and quality personnel
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Day 01(8:30 AM - 4:30 PM)
  • 08.30 AM - 09.00 AM: Registration and Meet & Greet.
  • 09.00 AM: Session Start
  • 9:00 -10:30
    • Seminar objectives review, expectations and scope.
    • Difference between Rx and OTC drugs
    • General OTC review process
    • OTC Monographs
  • 10:30 -10:45 Break
  • 10:45 -12:00
    • Proposing changes to OTC Monographs
    • ANDAs for Rx to OTC switch products
  • 12:00 -1:00 Lunch
  • 1:00 -2:00
    • De novo NDAs for OTC drugs
    • Discussion and questions
  • 2:00 -2:15 Break
  • 2:15 -4:00: more discussions of CGMPs
    • OTC ingredients
    • OTC Labeling
Day 02(8:30 AM - 12:00 PM)
  • 9:00 -10:30
    • FDA Enforcement Actions
    • FDA Inspections and 483s
    • FDA Warning Letters and Import holds
  • 10:30 -10:45 Break
  • 10:45 -11:30
    • Review & Summary.
    • Course Evaluations.
    • Adjourn.
  • 11:30 -12:00 Optional continued discussion of all of the above
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Loren Gelber

Loren Gelber
Regulatory Compliance Consultant (Ex-FDA Official)

Dr. Loren Gelber has more than 40 years in the pharmaceutical industry. She spent her first ten years at FDA, followed by 20 years in Regulatory Affairs and Compliance at various pharmaceutical companies, and the last ten years as a Regulatory Compliance Consultant. During this time she was a member of various groups and committees that worked on many compliance issues. She has published a number of papers and delivered various seminars and talks. Dr. Gelber holds a BA in Biology from Brandeis University, an MS in Chemistry from Brooklyn Polytechnic Institute (now part of NYU) and a PhD in Medicinal Chemistry from Northeastern University School of Pharmacy and Allied Health Professions. She current resides in Charlotte, NC.

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Payment Mode

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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

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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.

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

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