Manufacturing and Marketing OTC Drugs in Compliance with FDA Regulations (Updated to address recent Homeopathic Drug announcements by FDA & FTC): One and a Half Day In-Person Seminar
Bill Schwemer, Principal, Schwemer Consulting and Former Senior FDA & Industry Official
Courtyard Boston Cambridge, MA
| Thursday, November 12, 2015 | Friday, November 13, 2015
||Course "Manufacturing and Marketing OTC Drugs in Compliance with FDA Regulations (Emphasis on Topical Products)" has been pre-approved by RAPS as eligible for up to 10 credits towards a participant's RAC recertification upon full completion.
This interactive one and a half day seminar is intended to help companies understand the legal definitions of cosmetics, drugs, dietary supplements and why certain labeling statements for non-drug products may cause the agency to consider them new drugs without FDA approval.
The instructor, a leading industry expert and former FDA official, will explain differences in the way homeopathic and conventional drugs are regulated and how the risks presented by different types of drug products affect the rigor of FDA enforcement of Good Manufacturing Practices Regulations. A workshop will be held at the finale of the course to emphasize certain issues by having participants review labels of misbranded products and examples of recent FDA Warning Letters.
The seminar will address issues such as:
- How both labeling and advertising establishes ‘intended use’ which defines a product?
- When cosmetics, dietary supplements and foods might become drugs requiring FDA approval?
- How OTC drug monographs can help one to formulate products and design labels?
- Why are OTC drug/cosmetic combinations (cosmeceuticals) allowed, but not OTC drug/dietary supplement combinations?
- What are common personal care product ingredients that have both cosmetic and drug uses?
- The restriction on combining allopathic and homeopathic ingredients in a drug formula.
- Things that one needs to know when designing labels:
- Creative product names can cause a product to be misbranded.
- Proper formatting of Drug Facts boxed panels.
- Type size requirements and placement of information on principal display panels.
- Changes FDA now believes may be needed in monograph content and in changing monographs.
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.
This course will also include a discussion on recent FDA Public Hearings aimed at changing the current FDA OTC Monograph System (hearing held February 2014) and Homeopathic Marketing Rules (hearing held April 2015)."
- Understand FDA regulations and policies regarding manufacturing and labeling of OTC drugs covered by OTC drug monographs (minimal information is provided to contrast the new drug approval process).
- Learn the definitions of drug, cosmetic, and dietary supplements.
- Obtain tips on how to research FDA’s OTC drug monograph rulemakings.
- What labeling other than labels can define a product and cause it to be misbranded as a new drug.
- Learn that certain ingredients are safe and suitable for use in both drugs and cosmetics.
- Differentiate cosmetic ‘puffery’ claims from claims that FDA would likely consider drug claims.
- Learn how to formulate and label cosmeceuticals (cosmetics which are also drugs).
- Understand the differences in how allopathic (conventional) drugs and homeopathic drugs are regulated.
- Learn the basic requirements for marketing homeopathic OTC 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.
Seminar Fee Includes:
USB with seminar presentation
Hard copy of presentation
$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
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.
|Day One (8:30 AM - 5:00 PM)
||Day Two (8:30 AM - 12:30 PM)
Registration Process: 8:30 AM – 9:00 AM
Session Start Time: 9:00 AM
- 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
- 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
- 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
Meet Your Instructor
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.”
Register by P.O. / Check
Yes, I want to attend "Manufacturing and Marketing OTC Drugs in Compliance with FDA Regulations (Updated to address recent Homeopathic Drug announcements by FDA & FTC): One and a Half Day In-Person Seminar".
Click here to download P.O. form
If you are paying by check:
Checks should be payable to MetricStream Inc. (our parent company) and mailed to:
2600 E. Bayshore Road
Palo Alto, CA 94303
Send your team for maximum benefit.
Get your team up to speed!
Significant tuition discounts are available for teams of two or more from the same company. You must register at the same time and provide a single payment to take advantage of the discount.
||Get 10% off
|3 to 6 Attendees
||Get 20% off
|7 to 10 Attendees
||Get 25% off
||Get 30% off
Call toll free on +1-888-717-2436 if you have any queries.
Register by Wire Transfer
If you wish to pay by wire transfer, please call us toll free on +1-888-717-2436
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 @ firstname.lastname@example.org
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 $150 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 ($150) 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.
Courtyard Boston Cambridge
777 Memorial Drive,
Cambridge, MA, 02139, USA
November 12-13, 2015
Special Offer for the attendees of this seminar:
Rooms available at only $209 per night.
Call 866-323-4159 and Identify as ComplianceOnline
Please note: Hotel rooms are limited and based on availability
How to Reach
General Driving Directions:
From Boston Logan International Airport – BOS: 7.3 mile(s) W:
From Manchester-Boston Regional Airport – MHT: 55.1 mile(s) SE
- Exit Airport and take MassPike (I-90) West to Exit 20 (Cambridge)
- Continue straight and cross bridge
- Take first right after bridge onto Memorial Drive
- Hotel is 200 yards ahead on the left.
From T F Green Airport – PVD: 62.1 mile(s) NE
- Follow I-293 to I-93S towards Boston
- Take exit 26B (Storrow Drive West) and continue for 3 miles
- Bear right at the Central Square/MassPike exit and turn right at the light
- After crossing the bridge, take first right onto Memorial Drive and Hotel is on the left.
- Take I95N to I93N
- Then, take exit 26 (Storrow Drive West) and follow Storrow Drive
- Take the Central Square/MassPike exit and turn right at light
- After crossing the bridge, take first right onto Memorial Drive and Hotel is on the left.
- South Station: 5 mile(s) SE
- B.U. Central (on the Green Line): 0.8 mile(s) SE
- Central Station (on the Red Line): 0.8 mile(s) NE
- Back Bay Station (BBY): 3 mile(s) SE
- South Station (BOS): 5 mile(s) SE
Disclaimer: Directions to the venue above have been taken from the hotel website. Attendees are advised to check with the hotel for confirmation of these directions before starting for the venue. ComplianceOnline is not responsible for any inaccuracies in the same.
If you wish to partner with us for this event
contact us: email@example.com
call us: +1-888-717-2436.
Media Partner Benefits
- Logo and company data on the event website.
- Logo on the conference material distributed during the conference.
- Media partner’s brochure distributed along with conference material.
- Logo on all the mailings before and after the event.
- 10% discount to media partner's subscribers.
Media Partner To Do
- Banner (min 728x90 or 468x60) on the media partner website.
- Insertion of the event in the event calendar, both printed and/or online.
- Announcement article of the conference on the magazine and/or website.
- Dedicated email blast to media partner’s subscribers.
- Article on the magazine and/or website after the conference.
If you wish to sponsor this event
contact Cruise Webster: firstname.lastname@example.org
call us: (207) 576-4173
Boston Public Garden
This Frederick Law Olmsted-designed park, famous for its Swan Boats, has over 600 varieties of trees and an ever-changing array of flowers. It is America's first public garden.
Boston Public Library
The Boston Public Library was the first large municipally-funded public library in America. It has a central location right in the heart of Copley Square, facing the Trinity Church, easily accessible by taking the Green Line to Copley station (or also near to Orange Line Back Bay stop).
Fenway Park is the oldest Major League baseball park in the United States. Its small, intimate atmosphere really allows you to feel like you are "in the game." The park is situated right in downtown Boston - so it is very accessible if you are visiting the area.
Museum of Fine Arts
Boston's oldest, largest and best-known art institution, the MFA houses one of the world's most comprehensive art collections and is renowned for its Impressionist paintings, Asian and Egyptian collections and early American art.
Museum of Science
The Boston Museum of Science is a long-standing tradition for families in Boston, but that doesn't mean adults won't enjoy themselves too! Their exhibits range from dinosaurs to space travel to wildlife to physics to human biology to an in-depth look at Boston's "Big Dig" project.
This Italian neighborhood, Boston's oldest, is known for its wonderful restaurants and historic sights.
Old North Church
The signal from the steeple of Boston's oldest church triggered the War for Independence that led to the birth of America. On that fateful night in 1775, the two lanterns in the steeple told Paul Revere that the British were approaching by boat, not on foot.