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

This 120 minute training course will help attendees understand the fundamental steps of a deviation investigation with focus on using facts and objective evidence to arrive at root cause and CAPA. Learn how to identify and avoid potential pitfalls during deviation investigations.

This training program will help attendees grasp the essentials of project management and plan effectively for identifying project needs. It will also discuss practices for keeping content, process, and structure on track to produce positive outcomes.

This New ICH GCP E6 Revision 2 changes will cover those new requirements for running clinical trials, evaluate the changes and discuss how to implement these for sponsors, CROs and study sites. This session will enable you to meet the new international GCP standard to ensure the acceptance of clinical trial data by the regulatory authorities internationally including the European Union (EU), Japan, the United States, Canada and Switzerland.

This webinar will help the attendee gain an understanding of the requirements of current USP <85> Bacterial Endotoxin Test (BET), European Pharmacopoeia (Chapter 2.6.14) and the Japanese Pharmacopoeia (General Tests, No. 4.01). The webinar will provide the attendee the ability to understand the different LAL testing methodologies, choosing the best test method applicable to the product type, criticality of the BET test result as it applies to the release of a cGMP manufactured product.

Data analysis is one of the most powerful improvement tools because it can lead to cost reductions and preventive action. To use these techniques you need to know both the regulatory requirements and the analysis framework. This webinar gives you the tools and techniques to implement an effective data analysis program.

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.

This clinical compliance training will help attendees understand how they can develop and implement a Quality Assurance (QA) program at their clinical research site that ensures the staff are properly trained and that the research is carried out in accordance with regulatory expectations.

This training program will discuss the manufacturer’s obligations mentioned in the EN 50581, 2012 guidance document. The topics in the guidance document will be explored from the perspective of a US manufacturer.

This DHF regulatory compliance training will discuss the structure of a good Design History File, elements to look for when auditing a DHF and how to address issues. It will provide the information necessary to maintain a good DHF that will help manufacturers during a regulatory compliance audit.

This training program will list the documents required for equipment qualification and process validation and discuss how to manage documents appropriately. Attendees will gain insight into best practices for writing and maintaining a Validation Master Plan (VMP). The course will also discuss best practices for writing and executing sound protocols for equipment qualification (IQ, OQ, PQ) and process validation.

This webinar on objectionable microorganisms will explore the most current practices that define an objectionable microorganism and will provide a practical approach to determining just how objectionable it really is.

This webinar will discuss approaches to selecting vendors to perform manufacturing and testing activities as well as clinical study activities. The information obtained will enable implementation of an effective vendor selection program and a comprehensive vendor management and oversight program. The webinar will address aspects of requesting bids, performing audits, evaluating risks, and preparing plans and agreements for effective oversight and management.

This 90 minute webinar will help you comprehensively understand the IMPD (Investigational Medicinal Product Dossier) and the structure and content differences between a EU CTA Application and an FDA IND Application.

This webinar will present a Lifecycle Risk Management System that meets FDA and ISO requirements. That risk management system (based on ISO 14971) creates a closed loop system that identifies risks, and uses field use feedback to adjust risks and to improve designs and processes. The objective evidence produced by a Lifecycle Risk Management Systems can be used to demonstrate risk management compliance to 21 CFR Part 820 and ISO 13485.

This webinar on FDA electronic filings will discuss and provide clarification on the process of submitting drug establishment registration and drug listing information to the FDA using its Electronic Submission Gateway (ESG).

This webinar will discuss the FDA requirements for pharmacovigilance and complaint evaluation under GMP

As medical device requirements and expectations increase, coupled with strengthened standards, the design project must seek every opportunity to leverage activities in the area to satisfy requirements in other areas. This reduces the total work and helps make these processes more efficient. By attending this presentation, you will learn techniques to improve your device design project.

This webinar will discuss the FDA requirements for the involvement of the executive level in compliance governance. It will also discuss two major Supreme Court cases relied upon by the FDA to support their position on strict liability. Attendees will gain an understanding of the FDA policy and steps you can take to mitigate its impact.

This webinar will demonstrate how to use requirements tractability to systematically connect Engineering, Manufacturing and Risk Management processes, and how to systematically collect the objective evidence necessary to prove 21 CFR 820 compliance to the FDA.

This 60-minute webinar will help you understand what the true costs are for completing a clinical study and the unanticipated costs that may arise. You will learn about costs that a sponsor must include in a budget and costs that a site bears in the conduct of clinical research.