Laboratory Regulatory Compliance Training - Live Webinars, Recordings & CDs

This webinar on handling FDA inspectors will discuss practical tips to cope with a difficult FDA compliance officer or inspector. You will learn how to wiggle out of complicated situations, make legal arguments and challenges to the FDA agent and use meeting requests and other tools to ease tensions.

This webinar on preparing for FDA inspections will present simple but powerful tools, with real world examples on how to prepare for an impending FDA inspection. You will learn what essential last minute preparation activities can be done and others that should be avoided.

This method validation training will address the regulatory requirements which apply at the various stages of product development, and suggest proven strategies for compliant and phase-appropriate analytical method validation.

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 lab quality compliance training will provide a comprehensive overview of the Clinical and Laboratory Standards Institute (CLSI) Laboratory Quality Control Based on Risk Management; Approved Guideline, EP-23-A, produced in partnership with the Clinical Laboratory Improvement Amendment (CLIA).

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 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 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 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 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 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.

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.

This 90-minute webinar will clarify your confusion about Test Article Characterization for GLP drug studies. You will learn the correct way to use GMP characterization data in a GLP study, understand how to characterize a medical device as a test article, learn the common mistakes made in test article characterization and the basic requirements for drug and device stability testing.

This webinar will help you understand the significant differences between qualification and validation of an analytical method, the expectations and requirements of each, and their place in the analytical method lifecycle.

This webinar will provide a detailed information on the critical requirements of ISO 17025 and recommendations for cost effective implementation. You will learn steps towards laboratory accreditation and how to prepare for an ISO 17025 audit.

This 90-minute webinar will help you to develop a sound bioanalytical process to ensure quality data. It will cover techniques for bioanalytical data management for the purpose of assuring a regulatory agency that the data have been collected, managed, and archived to the highest standards of quality assurance. You will understand the aspects of bioanalysis that can be run according to GLPs and the aspects in which GLPs do not apply.

This webinar discusses the high risks of scientific misconduct in regulated studies. You will understand the main issues in producing study results of the highest integrity, learn how managers can implement a system for ensuring accurate and reliable data, understand the "red flags" of questionable data or reporting and develop a plan for identifying the high-risk steps in your operation.

This webinar on HPLC Method Development and Validation will outline similarities and differences in validations, and regulatory requirements, outline approaches specific to HPLC and to the various hyphenated detections systems.

This webinar on archiving GLP records will discuss the options for managing large archiving facilities to small facilities with one-room archives. You will receive practical tips on how to correct mistakes that agencies have cited regarding archiving.