ComplianceOnline

Drug Marketing Regulatory Compliance Training - Live Webinars, Recordings & CDs

Recorded/CD
OTC Drug Regulations

OTC Drug Regulations

  • Speaker: Loren Gelber
  • Product ID: 705446
  • Duration: 60 Min
This webinar will provide attendees with the knowledge and skills needed to develop and produce an OTC drug product for marketing and sale in the U.S.
CD/Recorded
$279
Recorded/CD
FDA's Ambitious Regulation of Social Media

FDA's Ambitious Regulation of Social Media

  • Speaker: Casper Uldriks
  • Product ID: 703853
  • Duration: 60 Min
FDA regulates advertising and promotion material as labeling. The legal definition of labeling covers just about anything that explicitly or implicitly conveys a message intended to affect a person’s behavior and decision outcomes. How FDA applies its legal tenants of false and misleading information or variations on that theme requires continual updating by FDA and constant re-evaluation by industry. Now the regulatory landscape involves other federal agencies and academic principles in psychology. It has become very complicated and will prove very costly if you knowingly or unknowing walk into one of FDA’s legal snares. This webinar will bring attendees up to speed so you are clearer about what is a problem, what is not a problem and what becomes a risk laden judgment call.
CD/Recorded
$279
Recorded/CD
Complaint Handling Requirements (US); Interrelationship with CAPA, Change Control, Adverse Event Reporting, Recalls and Life Cycle Process Activities

Complaint Handling Requirements (US); Interrelationship with CAPA, Change Control, Adverse Event Reporting, Recalls and Life Cycle Process Activities

  • Speaker: Vanessa Lopez
  • Product ID: 704758
  • Duration: 90 Min
This training program will provide the regulatory requirements (US) for complaint handling in the medical device and pharmaceutical industries. The course will touch on complaint sources, and details will be furnished on the interrelationships regarding complaint handling/change control/adverse event reporting/and recalls. The course will also include timeline requirements associated to adverse event reporting, which reporting formats to use, when to recall and types of recalls.
CD/Recorded
$249
Recorded/CD
Japan: Regulatory Compliance Requirements for Life Science Products

Japan: Regulatory Compliance Requirements for Life Science Products

  • Speaker: Robert J Russell
  • Product ID: 702979
  • Duration: 90 Min
This training on Japanese regulatory compliance requirements will explain the country's regulations and processes (including clinical trials, filings, etc.) and use real world experiences to show how compliance issues are culturally handled for life science products in Japan.
CD/Recorded
$249
Recorded/CD
Nutrition and Health Claims Regulation (NHCR) in the European Union

Nutrition and Health Claims Regulation (NHCR) in the European Union

  • Speaker: Vicente Rodriguez
  • Product ID: 705492
  • Duration: 60 Min
This webinar on Nutrition and Health claims (NHCR) will provide guidance to any food business operator intending to present food products as having nutritional or health benefits should be aware of the legal possibilities and limitations that the EU system offers.
Recorded/CD
FDA Regulation and Legislation of Cosmetics

FDA Regulation and Legislation of Cosmetics

  • Speaker: Norma Skolnik
  • Product ID: 704317
  • Duration: 60 Min
The webinar training will cover FDA regulations for marketing cosmetics and help attendees learn about new proposed legislation which will place new requirements on cosmetic product marketing in the U.S.
CD/Recorded
$249
Recorded/CD
Commercial and HTA Policy in the UK

Commercial and HTA Policy in the UK

  • Speaker: Leela Barham
  • Product ID: 705431
  • Duration: 90 Min
This webinar will provide an understanding of the key European market’s approach to pricing including the details of Pharmaceutical Price Regulation Scheme (PPRS). It will further discuss the key issues shaping the future of HTA policy in the UK.
Recorded/CD
Drug Pharmacy Compounding

Drug Pharmacy Compounding

  • Speaker: Rachelle D Souza
  • Product ID: 704907
  • Duration: 60 Min
This webinar will discuss conditions under which certain compounded human drug products are exempted from compliance with cGMPs, labeling, market approval and reporting requirements. It will cover conditions that require an outsourcing facility to comply and the latest developments in drug pharmacy compounding.
CD/Recorded
$249
Recorded/CD
How to Survive a DEA Inspection Series - For Manufacturers of Controlled Substances

How to Survive a DEA Inspection Series - For Manufacturers of Controlled Substances

  • Speaker: Carlos M Aquino
  • Product ID: 705164
  • Duration: 60 Min
This training covers DEA record-keeping and security topics that a DEA registrant must comply with when handling controlled substances. The focus is elements of what occurs during that unannounced inspection and the auditing methods.
Recorded/CD
What You Should Know About Export Requirements for FDA Regulated Products from US to Foreign Countries

What You Should Know About Export Requirements for FDA Regulated Products from US to Foreign Countries

  • Speaker: Rossano V Gerald
  • Product ID: 705186
  • Duration: 60 Min
When exporting outside the U.S., exporters must consider the Food and Drug Administration (FDA) provisions as it helps them understand what documents and procedures are needed in coordination with the transaction process. This training program will provide an in-depth explanation of FDA-regulated products that are exported from the United States to foreign countries. Also, it will address what export documentation must be used in the transportation of FDA-regulated products.
Recorded/CD
How to Survive a DEA Inspection Series: "Understanding a DEA Computation Chart for Manufacturers or FIND=FINE"

How to Survive a DEA Inspection Series: "Understanding a DEA Computation Chart for Manufacturers or FIND=FINE"

  • Speaker: Carlos M Aquino
  • Product ID: 705163
  • Duration: 60 Min
The presentation is tailored for those corporate leaders and employees of DEA registered manufacturers responsible for handling Schedules I through V controlled substances and List I regulated chemical products. This training will cover several recommendations to improve your methods of record-keeping required of DEA registrants.
Recorded/CD
Moving FDA Boundaries for Direct-to-Consumer Advertising

Moving FDA Boundaries for Direct-to-Consumer Advertising

  • Speaker: Casper Uldriks
  • Product ID: 705033
  • Duration: 90 Min
FDA encourages companies that offer DTC advertising to include accurate information in their ads. Through a comprehensive surveillance and enforcement program, the agency ensures that consumers are not misled or deceived by advertisements that violate the law. This webinar will bring attendees up to speed so you are clearer about when DTC advertising makes you ripe for legal picking by the FDA.
CD/Recorded
$279
Recorded/CD
U.S. Adverse Event Reporting Regulations for Drugs, Dietary Supplements and Cosmetics

U.S. Adverse Event Reporting Regulations for Drugs, Dietary Supplements and Cosmetics

  • Speaker: Norma Skolnik
  • Product ID: 704371
  • Duration: 60 Min
In order to market dietary supplements and OTC drugs in the U.S., reporting serious adverse events is required. It’s essential to understand these important FDA requirements to assure regulatory compliance and avoid an FDA warning letter or 483 audit issues.
CD/Recorded
$249
Recorded/CD
Regulation of Natural Health Products in Canada

Regulation of Natural Health Products in Canada

  • Speaker: James Russell
  • Product ID: 704044
  • Duration: 90 Min
This training program will discuss regulations that impact Natural Health Products in Canada. It will detail how to verify the products’ compliance with published regulations. It will also detail requirements for registration, labeling and acceptable marketing claims.
CD/Recorded
$229
Recorded/CD
Comparing the Pharmaceutical and Medical Device Product Lifecycles

Comparing the Pharmaceutical and Medical Device Product Lifecycles

  • Speaker: Howard Cooper
  • Product ID: 704853
  • Duration: 120 Min
This webinar will help you gain a greater understanding of regulatory and compliance requirements and how the early product lifecycle requirements establish the basic groundwork as a foundation from product development to commercialization continuing to out commercialization and product discontinuation.
CD/Recorded
$249
Recorded/CD
Dietary Supplements - Regulatory Compliance Requirements, Product Claims, Labeling Issues and FDA Updates

Dietary Supplements - Regulatory Compliance Requirements, Product Claims, Labeling Issues and FDA Updates

  • Speaker: James Russell
  • Product ID: 702154
  • Duration: 90 Min
This training will review the dietary supplement regulations in the USA and explain how to verify that your products are compliant with the most recent regulations and provisions. It covers the FDA regulatory structure and considerations for manufacturing, labeling and advertising dietary supplements.
CD/Recorded
$279
Recorded/CD
4-Hour Virtual Training: FDA Regulations for Marketing and Labeling OTC Drugs in the U.S.

4-Hour Virtual Training: FDA Regulations for Marketing and Labeling OTC Drugs in the U.S.

  • Speaker: Norma Skolnik
  • Product ID: 704530
  • Duration: 4 hrs
The objective of this virtual training seminar is to assist attendees in understanding and being able to apply FDA regulations for OTC drugs and to label and market them successfully in the U.S. while avoiding regulatory problems. The program will also explore other verticals such as: OTC drug monographs and their importance to product marketing, a summary of OTC drug GMP regulations, FDA rules for adverse event reporting of OTC drugs, avoiding FDA Warning Letters, and more.
Recorded/CD
3-Hour Virtual Training: Russia Regulatory Compliance Requirements for Life Science Products

3-Hour Virtual Training: Russia Regulatory Compliance Requirements for Life Science Products

  • Speaker: Robert J Russell
  • Product ID: 704356
  • Duration: 3 hrs
This training course will provide a detailed overview of the regulatory requirements, local challenges and important cultural aspects of working with the lifecycle of life science products (pharmaceuticals, medical devices, biologics and combination products) as an importer or producer in Russia. It will offer a deeper understanding of cultural norms, and will discuss best practices for establishing relationships and protecting your intellectual property to be integrated into your company’s training and corporate business strategies.
CD/Recorded
$429
Recorded/CD
Creating a Global Regulatory Plan

Creating a Global Regulatory Plan

  • Speaker: Cheryl Wagoner
  • Product ID: 703283
  • Duration: 60 Min
This regulatory training will help attendees understand key benefits for implementing and maintaining an effective global regulatory plan. Attendees will also gain exposure to the elements and a methodology for global regulatory plan development and maintenance.
CD/Recorded
$229
Recorded/CD
Social Media for FDA Regulated Industry: Navigating the Web of Rules and Guidance

Social Media for FDA Regulated Industry: Navigating the Web of Rules and Guidance

  • Speaker: Michael Walsh
  • Product ID: 703466
  • Duration: 60 Min
This webinar will provide an overview of regulations for the use of social media for promoting FDA regulated products. Attendees will learn how to comply with these regulations and avoid enforcement actions.
CD/Recorded
$229
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