Life Sciences Regulatory Compliance Training - Live Webinars, Recordings & CDs

This microbiology laboratory training will provide a comprehensive overview of the infrastructure of a compliant microbiology testing laboratory, preparation for an inspection, potential areas for nonconformance, test failures and resolution of audit findings.

This 3-hr virtual seminar will offer a comprehensive ICH GCP training for all healthcare professionals involved in clinical research.

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 90-minute webinar will examine the many myths that get in the way of clinical standards adoption and demonstrate how complying with required standards benefits both the FDA and sponsors.

This GCP compliance training will discuss the regulatory requirements for handling protocol deviations and violations and the importance of documentation that is required. The presenter will provide specific examples and proven tips for handling instances of protocol violations.

This training on FDA compliant electronic records and signatures will will provide an overview and historical perspective of the Part 11 regulation, the general Part 11 requirements, electronic records requirements, and electronic signatures requirements.

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 will assist clinical research personnel in developing/acquiring SOPs for their site. You will learn how to create a compliant but user–friendly set of SOPs that can pass regulatory audits and also be a useful tool for the site staff.

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 GLP training will guide you in developing your laboratory's incident management plan to ensure that your laboratory policies and procedures are in compliance and your patients, visitors and staff are protected from accidents or unexpected events.

This ISO 13485 requirements training will provide guidance to medical device companies in developing an adequate Quality Management System (QMS) in accordance with ISO 13485 and FDA expectations. This webinar will also benefit medical device companies that are planning to market their products in Europe.

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 highlight the evidence normally requested during audits and inspections of biotechnology analytical labs. You will learn how your laboratory's biotechnology analytical methods can fulfill stated or implied regulatory requirements (the US FDA refers to these as the “C” in CGMPs).

This medical device process validation training will use recent warning letters to explain the regulatory requirements for process validation and what FDA Investigators look for. It will cover process validation components (IQ, OQ, and PQ), and the content of protocols and reports.

This medical device 510(k) training will explain the basics of 510(k) submissions and discuss tips, strategies and tools to develop and execute an approval strategy ensuring the fastest possible path to market.

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 on microbiological sampling for foods will address fundamental approaches to sampling, from raw materials to finished products. Topics will include sampling plans, sample collection methods and chain of custody issues. A primary focus will be on interpretation of results, based on the limitations of sampling plans and microbiological methods.