Organic Natural Cosmetics

Palo Alto, CA, USA (PRWEB) November 07, 2013

ComplianceOnline, the leading governance, risk and compliance advisory network with over 500 experts in various regulatory subjects, today announced a seminar on Manufacturing and Marketing Cosmeceutical and Homeopathic OTCs: Complying with FDA’s Rules for Drug Products that do not require FDA Pre-Approval. The one and a half day seminar by former FDA Official Bill Schwemer will be held on November 14 and 15 in Miami, FL.

The seminar will explain in depth the FDA rules and policies regarding manufacturing and labeling of low risk OTC drugs not covered by approved New Drug Applications.

For more information or to register for the seminar, please click here.

Seminar instructor Bill Schwemer is an ex-FDA official having more than 50 years of experience in dealing with FDA compliance matters. He spent 30 years 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.

During the one and a half day seminar, Mr. Schwemer will focus on FDA rules and policies regarding manufacturing and marketing of drug products that do not require FDA pre-approval. He will explain the legal definitions of cosmetics, drugs, dietary supplements and differences in the way homeopathic and conventional drugs are regulated. It will help the attendees understand OTC drug monographs. Attendees will learn the best practices for complying with GMP regulations for low risk products and will get tips to minimize the regulatory risk of warning letters and other FDA enforcement actions.

The seminar will be beneficial for professionals working in cosmetics, nutritional, liquid soap or other companies that want to add OTC Drug ingredients to, or making drug claims for their products. It will provide valuable guidance to senior managers of business owners, product managers, labeling professional, regulatory and quality professional, sales, marketing and customer service, product R & D staff, product formulation engineers and manufacturing professionals.

Date: Thursday, November 14 (8.30 AM- 5.00PM) and Friday, November 15, 2013 (8.30AM- 1.00PM)

Location: Miami, FL

Registration Cost: $ 1,499.00 per registration

Early bird discounts: For discounts on early registrations, please click here.

Register by phone: Please call our customer service specialists at +1-650-620-3937 or email to customercare(at)complianceonline(dot)com

For more information on ComplianceOnline or to browse through our trainings, please visit our website.

About ComplianceOnline

ComplianceOnline is a leading provider of regulatory compliance trainings for companies and professionals in regulated industries. ComplianceOnline has successfully trained over 35,000 professionals from 9,000 companies to comply with the requirements of regulatory agencies. ComplianceOnline is headquartered in Palo Alto, California and can be reached at http://www.complianceonline.com. ComplianceOnline is a MetricStream portal. MetricStream (http://www.metricstream.com/) is a market leader in Enterprise-wide Governance, Risk, Compliance (GRC) and Quality Management Solutions for global corporations.

For more information please contact:

A Reuben Bernard

Manager of Program Marketing

ComplianceOnline

2600 E Bayshore Rd

Palo Alto CA USA 94303

650-620-3937 phone

650-963-2530 fax

reuben(at)complianceonline(dot)com

http://www.complianceonline.com.

Palo Alto, CA, USA (PRWEB) January 17, 2014

ComplianceOnline, the leading governance, risk and compliance advisory network with over 500 experts in various regulatory subjects, today announced a seminar on FDA’s Regulation of OTC Drug Products. The two day seminar led by regulatory affairs expert Karl M. Nobert will be held on February 13-14, 2014 in the Houston, TX.

This two day seminar will provide tools needed to develop and produce an OTC Drug Product for marketing and sale in the U.S. and for mitigating potential enforcement risks.

For more information or to register for the seminar, please click here.

Seminar instructor Karl M. Nobert is a food and drug regulatory attorney with the law firm of Squire Sanders in Washington, DC. Mr. Nobert provides regulatory advice and counseling to both large and small domestic and international pharmaceutical companies on regulatory issues related to the U.S. Food and Drug Administration’s review and approval of new drug products. He also has considerable experience related to the regulation of biologics including cellular and genetic therapies, and veterinary drug products.

During the two day interactive seminar, Mr. Nobert will discuss U.S. Food and Drug Administration’s (“FDA”) regulation of OTC drug products. He will explain the strategies for marketing and promoting OTC drug products, and for mitigating potential enforcement risks. The seminar will give the attendees an understanding of how to identify and successfully navigate an OTC drug monograph. He will also explain the difference between the various pathways for commercializing an OTC drug product and the required elements of a compliant OTC drug label.

The seminar will be beneficial for people tasked with formulation, manufacturing, labeling, marketing and promotion, import / export of OCT drug products and responsible for overseeing a company’s regulatory strategies. It will provide valuable guidance to senior quality managers, quality professionals, regulatory professionals, compliance professionals, production supervisors, manufacturing engineers, production engineers, design engineers, contract manufacturers, importers and custom agents.

Date: Thursday, February 13 and Friday, February 14, 2014, 8.30 AM- 4.30 PM

Venue & Location: DoubleTree Suites by Hilton Houston, TX

Registration Cost: $ 1,499.00 per registration

Early bird discounts: For discounts on early registrations, please click here.

Register by phone: Please call our customer service specialists at +1-650-620-3937 or email customercare(at)complianceonline(dot)com

For more information on ComplianceOnline or to browse through our trainings, please visit our website.

About ComplianceOnline

ComplianceOnline is a leading provider of regulatory compliance trainings for companies and professionals in regulated industries. ComplianceOnline has successfully trained over 35,000 professionals from 9,000 companies to comply with the requirements of regulatory agencies. ComplianceOnline is headquartered in Palo Alto, California and can be reached at http://www.complianceonline.com. ComplianceOnline is a MetricStream portal. MetricStream (http://www.metricstream.com/) is a market leader in Enterprise-wide Governance, Risk, Compliance (GRC) and Quality Management Solutions for global corporations.

For more information please contact:

A Reuben Bernard

Manager of Program Marketing

ComplianceOnline

2600 E Bayshore Rd

Palo Alto CA USA 94303

650-620-3937 phone

650-963-2530 fax

reuben(at)complianceonline(dot)com

http://www.complianceonline.com

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