ComplianceOnline

This interactive one-and-a-half-day seminar is intended to educate regulatory and quality professionals regarding the rather complicated regulations that distinguish Non-prescription Drugs from other products such as foods, cosmetics, dietary supplements and prescription drugs that sometimes contain the same ingredients. Recent FDA actions such as the banning of antibacterial soaps and ongoing programs that may impact manufacturers and private label distributors will be discussed. It will explain differences in the way homeopathic and conventional drugs are regulated and update participants on FDA’s application of GMP regulations to manufacturing low risk drugs that could be sold as cosmetics with the same ingredients, but different labeling.

The seminar will address issues such as:

  • Registering facilities and listing products with FDA.
  • How the intended use of the product owner defines a product?
  • Can a drug contain both homeopathic and conventional drug ingredients?
  • Update on activities following FDA’s 2015 Public Hearing on Homeopathic drugs?
  • Information that must appear on principal display panels.
  • Format and type size requirements for label text.
  • Must you have a contract and/or separate quality agreement with a contract manufacturer?
  • FDA’s OTC Drug Monograph rules and how they benefit small business.
  • How an “old drug” can become a “new drug” subject to FDA’s rigorous approval process.
  • The relationship of OTC Monograph labeling requirements to "drug facts" boxed labeling.
  • Labeling products that have both OTC drug and cosmetic claims?
  • What are basic requirements for marketing Homeopathic OTC drugs?
  • GMP requirements for cosmeceuticals that can be met at lower cost.

While certain discussions will be applicable to solid dose form and other higher risk ingestible OTC drugs, including items recently switched from Rx to OTC status, this program is intended primarily to address topical liquid, suspension, ointment, powder, and emulsion products that have no dosage limitations.

Note: "Course updated to address recent Homeopathic Drug announcements by FDA & FTC."

Seminar instructor Bill Schwemer is an ex-FDA official with more than 50 years of experience in dealing with FDA compliance matters that include 30 years he spent working with the FDA as a field investigator, director of field investigations, assistant associate commissioner for regulatory affairs, and special assistant to deputy commissioner for policy.

Learning Objectives:

  • Understand FDA rules and policies regarding manufacturing and labeling of low risk OTC drugs not covered by approved New Drug Applications.
  • Learn the importance of knowing the legal definitions of FDA regulated products.
  • Understand how labeling other than labels and advertising can define a product and cause it to be misbranded or considered a new drug.
  • Differentiate cosmetic “puffery" claims from those that FDA would likely consider drug claims.
  • Understand the differences between allopathic (conventional) drugs and homeopathic drugs.
  • Recognize ways to manufacture low health risk products at minimum cost, yet still meet the intent and basic requirements of GMP regulations.
  • Learn how to minimize the regulatory risk of a Warning Letter (or other FDA action) and what to do if you get one.
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

Who Will Benefit:

This course is intended for personal care product manufacturers and other businesses that wish to develop and/or market drugs that do not require FDA approval. It will also benefit cosmetic, nutritional, liquid soap and other companies that are considering health related claims for their products, but wish to avoid labeling that would make them new drugs lacking FDA approval. While the emphasis is on topical OTCs, well over half of the presentations are also applicable to OTCs taken internally. It will especially benefit own label distributors and smaller firms that do not have a regulatory professional on their staff. This includes:

  • Senior Managers / Business Owners
  • Product Managers
  • Labeling and Artwork Designers
  • Regulatory and Quality Professionals
  • Sales and Marketing Managers
  • R&D Managers and Staff

Topic Background:

A company may begin to manufacture OTC drug products without any consultation with the FDA or the agency's approval. However, drug registration and listing forms shall be submitted to the FDA when marketing begins. The allopathic or conventional drug products, including cosmeceuticals, need to conform to an OTC drug monograph. Monographs are not established for homeopathic drugs; however, both allopathic and homeopathic drugs need to be manufactured in conformance with FDA's Good Manufacturing Practices (GMPs) regulations. A few GMP requirements are not required for homeopathic drugs and generally the rigor and therefore the cost of implementing adequate GMPs for low risk OTC drug products can be less.

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Day 01(8:30 AM - 5:00 PM)
  • 08.30 AM - 09.00 AM: Registration
  • 09.00 AM: Session Start
  • 9:00 AM - 9:15 AM: Introduction
  • 9:15 - 10:15 AM: Overview of Law and Regulations for Drug Products
    • History of legislation
    • Prohibited acts
    • Basic labeling definitions/requirements
  • 10:15 - 10:30 AM: Break
  • 10.30 - 11:15 AM: Labeling Idiosyncrasies - Cosmetics, Drugs, Dietary Supplements
    • Defining personal care products
    • Identifying confusing regulatory issues
  • 11:15 - 12:00 PM: OTC Monographs - Focus on Topical Products
    • How they are established
    • Product categories
    • Requirements
  • 12:00 - 1:00 PM: Lunch
  • 1:00 - 1:45 PM: Cosmeceuticals - Cosmetics that are also Drugs
    • Dominance of drug labeling rules
    • Monographs most applicable to cosmeceuticals
    • Placing cosmetic and drug claims on labels
  • 1:45 - 2:30 PM: More on Monographs
    • Comparing rulemakings
    • Finding your way to useful information in rulemakings
    • FDA seeking changes in monograph process
  • 2:30 - 3:00 PM: OTC Drug Facts Labeling
    • The boxed labeling format
    • Relationship to monographs
  • 3:00 - 3:30 PM: Break
  • 3:30 - 4:15 PM: FDA Policy Regarding Marketing Homeopathic Drugs Understanding CPG 400.400
    • FDA concern about health fraud
    • What is a homeopathic product
    • Labeling requirements
  • 4:15 - 4:45 PM: Reporting Serious Adverse Events to FDA
    • Define reporter, adverse event and responsible person
    • When and how to report
  • 4:45 - 5:00 PM: Q & A
Day 02(8:30 AM - 12:30 PM)
  • 8:30 - 10:00 AM: Complying with Finished Drug CGMPs (for Low Risk Products)
  • 10:00 - 10:30 AM: Break
  • 10:30 - 11:00 AM: FDA Guidance: Contract Manufacturing of Drugs
  • 11:00 - 12:15 AM: Workshop
    • Review labels and comment
    • Review and discuss FDA Warning Letters
  • 12:15 - 12:30 PM: Wrap-up, Hand Out Certificates
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Bill Schwemer

Bill Schwemer
Principal, Schwemer Consulting and Former Senior FDA & Industry Official

Bill Schwemer is an ex-FDA official with more than 50 years’ experience in FDA compliance matters. He was an FDA field investigator and compliance officer in two districts. As director, division of field investigations, he managed the FDA foreign inspection program and his staff supported the district investigations branches. He was a senior official in FDA's Office of the Commissioner in both the Offices of Regulatory Affairs and Policy. His industry experience includes V-P of RA/QA at a personal care products company and consulting for businesses nationwide and in Europe and Asia. His consulting business in recent years has been primarily for pharmaceutical and personal care products companies. He has published more than 125 articles and since becoming a consultant has successfully served as a regulatory compliance expert witness in 22 lawsuits.

In his FDA Office of Regulatory Affairs positions, Mr. Schwemer had insights on all current OTC Drug Compliance Policy Guides (CPGs) and approved either original drafts or revisions on behalf of the office. Recently, he petitioned FDA to revise the CPG “Conditions Under Which Homeopathic Drugs May be Marketed.”

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Seminar One Registration

November 7-8, 2017, San Francisco, CA
(Registrations till August 5, 2017 - $1699)
(Registrations till September 5, 2017 - $1799)
(Registrations till October 5, 2017 - $1899)
(Registrations after October 5, 2017 - $1999)

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November 7-8, 2017, San Francisco, CA
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The registration fee includes: the workshop; all related course materials; morning tea/coffee on both the days, lunch and afternoon tea/coffee on day one.


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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.

Location:

San Francisco, CA
(Venue to be announced shortly)

November 7-8, 2017

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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:

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