Compliance Training Webinars for Regulated Industries

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 to develop and implement a cost-effective, yet practical strategy, for Industrial Hygiene (IH) monitoring consistent with prevailing standards of practice. You will learn how to select the appropriate sampling and analytical methods for your IH monitoring plan.

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 90-minute webinar will help you understand the application and requirements of OSHA Hazardous Energy Control (29 CFR 1910.147, 29CFR1910.333), commonly known as Lockout / Tagout (LOTO), and the topics that have been interpreted and reviewed in the compliance guidelines.

This FDA validation training will describe methods for planning and executing spreadsheet validations that satisfy FDA requirements.

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 understand the competence and training requirements in the Quality Management Systems for medical devices, especially FDA QSR, ISO 13485, and even ISO 9001.

This webinar will build upon a basic knowledge of noise monitoring and hearing loss to help in understanding the instruments used in performing noise monitoring and how best to use them in developing and implementing a practical strategy for performing noise monitoring.

This webinar will review the principal differences in regulations governing investigational device (IDE) studies and drug (IND) studies and help you understand where the regulations diverge and how this impacts the design and execution of device studies.

This webinar will focus on internal controls models that you can adapt for your organization. It will cover the top 20 internal controls for fraud detection and prevention, and show how you can monitor them for effectiveness.

This 90-minute webinar will introduce basic concepts in fraud, principles and associated issues, including a major pertinent banking case study in Internal Fraud committed by a rogue trader.

This 90-minute webinar will introduce you to the components that make up today’s e-Banking services. It is also a precursor, for those unfamiliar with it, to further modules focusing on understanding the risks associated with e-Banking, as well as the compliance challenges we face.

This training provides an up-to-date understanding of regulatory requirements for the development and implementation of biomarkers in drug development programs, as well as highlights of the most recent FDA sources on general, imaging (Including PET) and pharmacogenomic biomarkers.

This 90-minute webinar will help you establish an effective Good Clinical Practice (GCP) by providing a current, accurate and complete (CAC) review and understanding of the relevant and applicable regulations for clinical trials or studies, the requirements and compliance in a systematic, integrative (SI) manner.

This webinar on pharmaceutical water systems will explain practical best practices for outlet use and sampling to reflect the true water quality and how to most effectively use the resulting data to improve manufacturing’s water use practices and maintain water system control before problems arise from biofilm-related contamination.

This webinar will focus on the key elements of a comprehensive Lockout/Tagout (LOTO) program, the 3 common LOTO trouble areas, the 5 types of machine guards and what to expect in an OSHA inspection of your LOTO program. A real-world 9-step LOTO procedure that works will also be discussed.

This webinar will help you understand the process, requirements, quality and safety considerations for demonstrating biosimilarity to a Reference Product. You will learn about what type and how much clinical data are needed to support a showing of biosimilarity.

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 90-minute webinar will cover the best industry practices for Failure Modes and Effects Analysis (FMEA). You will learn what mistakes to avoid, how to reduce design and manufacturing defects, and how to implement risk management efficiently.

This session will provide a roadmap for the implementation of key metrics that can be used in formulating a P2P Dashboard. Attendees will learn how to actually use metrics and trends to develop areas for business process improvement.