Pharmaceutical Regulatory Compliance Training - Live Webinars, Recordings & CDs

This webinar will provide a summary of the additional medicare reporting requirements under the Sunshine Act rules, and tips for assuring compliance to protect both the manufacturers of FDA regulated products and physicians.

This webinar on dietary supplements will cover product ingredient reviews and FDA requirements for labeling your products in the US. You will learn how to avoid claims, what claims are permissible and how to remedy challenged claims.

This webinar on FDA social media regulations will discuss the best practices utilized by medical device, drug and other FDA and FTC regulated industries when using social media channels, i.e., Web 2.0, like Facebook, Twitter, YouTube and LinkedIn to promote products.

This training on FDA cGMPs for Dietary Supplements and Nutraceuticals will discuss current FDA regulations, GMP requirements and techniques to be compliant using easier, shorter and convenient strategies. Case studies of FDA audit experiences will be presented for easy understanding.

This session will discuss in detail the Final Rule for the Physician Payment Sunshine Act, its impact and how to prepare for it. You will learn about reporting, certification and registration deadlines and what specifically needs to be reported or provided to CMS.

This training on OTC drug marketing is intended to be a practice-based online workshop that will explain what you need to know to successfully market and sell an Over-the-Counter drug product in the United States; and provide strategic advice for avoiding FDA enforcement action.

This webinar will cover how conventional food companies should label their products for the US market per FDA requirements, considerations avoid claims, building regulatory compliance into company programs for development and launch of properly labeled dietary supplements.

This training will cover FDA requirements for labeling dietary supplements. It will show how you can avoid dietary supplement labeling claims by properly labeling your products for the US market per FDA requirements.

This session on conducting effective GMP trainings will cover proven learning techniques for technical and compliance related trainings. It will answer key questions about how to make GMP training sessions more engaging and even fun for the learners in your organization.

This webinar on dietary supplement adverse event reporting will explain the requirements under federal law as to when serious adverse event reports must be submitted to the FDA, what information and when it must be submitted. In addition, it will highlight the recordkeeping requirements under the law pertaining to all adverse event reports.

This healthcare compliance training will explain how the FCA, the AKS and the Federal Physician Self Referral Law (Stark II) work, the prohibitions, exceptions and safe harbors. It will review recent examples to show how they interface and can potentially impact you/ your organization.

This webinar will cover how dietary supplement companies should label their products for the US market per FDA requirements, considerations avoid claims, building regulatory compliance into company programs for development and launch of properly labeled dietary supplements.

This training will outline the best practices in responding to a FDA Warning Letter so the consequences of the findings do not escalate beyond the current status.

This webinar on social media advertising compliance will provide perspective on how food and drug companies can leverage social media to promote brands, discuss how social media can expose companies to unique regulatory compliance challenges, and show how company compliance programs can be designed to address these challenges.

This webinar will provide an introduction to FDA’s regulation of product labeling and promotion; and the Agency’s position with regards to off-label promotion and how the Court’s decision in the Caronia case might affect the off-label promotion of Rx drug products and medical devices.

This social media compliance training for healthcare companies will cover the legal and regulatory requirements governing the use of social media. A scenario-based learning approach will be used to show how to create a successful social media team by selecting members from relevant stakeholders, and prepare social medial policies and procedures.

This webinar will familiarize you with FDA requirements for electronic and digital signatures, and the agency's inspection and enforcement practices. Particpants will recieve complimentary hand-outs for easy implementation.

This webinar will help you understand the industry background to the current transition to Risk-based Verification processes and the current trend in implementation by industry. You will learn the regulatory foundations, industry guidance, and primary components of risk-based verification as it relates to an overall specification, design, and verification program as outlined in ASTM E-2500-07; “Standard Guide for Specification, Design and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment;” ASTM, 2007. Key implementation considerations and initial steps will be discussed.

This webinar will discuss the use of Lean Six Sigma methodology for product complaint investigations and offer a standardized approach for FDA regulated life science companies to follow whenever product complaint investigations are needed.

This 90-minute webinar on personnel practices and microbial control in Pharmaceutical, Biotech, and Medical Device manufacturing will cover effective ways to train personnel on gowning and personnel practices in cleanroom operations to limit contamination. This webinar will also address controlling microorganisms on process equipment and product contact surfaces.