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

This hour-long session will provide insights on liabilities arising due to non-compliance and oversight in clinical trials. The clinical affairs expert will also discuss identifying the types of litigation and how best to eliminate the source of risk with real world examples. Participants will learn to appreciate the importance of formal training in conducting proficient clinical trials.

This ICH Q10 training /webinar will discuss the evolution and interpretation of the pharmaceutical GMPs as a quality control regulation to the Quality Assurance emphasis of the Pharmaceutical Quality System as defined in ICH Q10.

The global regulatory environment for tobacco, e-cigarette and e-liquid products is rapidly evolving as legislators and regulators in the United States, European Union and Asia attempt to understand the health and safety concerns presented by these novel products, and develop appropriately tailored laws and regulations. This training course will present an overview of e-cigarette regulations in Asia, the European Union and around the world. It will also detail the key provisions of FDA’s deeming regulations.

In this 90-minute training on laboratory Out-of-specification (OOS) investigations, you will learn what constitutes an OOS observation, what is the OOS investigation process described in the OOS guidance and steps to be taken in the laboratory in the event of an OOS observation.

This webinar will elaborate the scope and content of the recent FDA guidance on validation of analytical methods. The webinar will also illustrate the lifecycle management of analytical procedures and train attendees on documentation requirements and verification of submitted methods.

This training on South East Asia regulatory compliance for life science products will discuss the regulatory structure and requirements for compliance with in-country regulations for pharmaceuticals, medical devices, biologics and combination products. This webinar will focus on a high-level composite of requirements in Taiwan, Hong Kong, Singapore, Malaysia, Vietnam & Thailand.

This training on clinical trial Statistical Analysis Plans (SAP) will review writing, timing and specific content of the SAP in the context of FDA guidance based on ICH E9 with references to ICH E3 and E6. We will work through a sample template and discuss how to approach each section for maximum clarity and ease of interpretation at the end of a study.

The introduction of Vanessa’s Law in late 2014 has significantly changed the enforcement landscape, providing for the possibility of higher penalties than ever before in Canada. This training program will offer an overview of the new law and its potential impact on industry.

This trade webinar will explain the complex US entry process so companies that import FDA regulated products will benefit from a better understanding of how the process works. It will discuss factors and actions that can lead to an import shipment being delayed or not allowed entry into the USA.

This training on using certified reference material in analytical laboratories will cover FDA and international requirements for selection, purchasing, testing, storage and use of (certified) reference material.

This CAPA program provides the framework for avoiding an FDA warning letter and increasing quality standards for your organization while keeping production levels high.

This training on laboratory controls will focus on the systems within a laboratory that will be audited by an FDA investigator using the systems based inspection approach. You will understand the FDA focus on systems and how you might improve procedures in your laboratory to be better prepared for a regulatory agency inspection.

This webinar will clarify the cleaning and material handling requirements outlined in USP 797 and present additional best practice guidelines. It will discuss principles related to the selection, preparation and use of cleaning, disinfection and deactivation agents. The correct sequencing of critical activities related to daily and monthly cleaning of both primary and secondary engineering controls will be presented as well.

This webinar will help you clearly understand, classify and determine what deviations to report in clinical studies. It will also explain, in detail, the terminology applied to deviations.

This webinar will provide practical information on the FDA requirements for complaints, but expands the traditional scope to include closely linked, but often overlooked processes. It will explore the problems that can trigger FDA reports such as Medical Device Reports (MDRs), Corrections Reports, and Removals Reports. On the servicing side, the course will detail the requirements to analyze service reports, show how they can trigger MDRs, and automatically become complaints. This webinar will minimize the use of regulatory language and easily illustrate how participants can implement an effective and unified system. As an added bonus, the webinar will include information on the UDI rule and the eMDR rule.

This FDA Software Validation and Verification training/webinar will review the validation planning process with particular emphasis on avoiding six common pitfalls.

This 90-minute webinar will provide an overview of regulatory management for clinical trials. It will discuss key regulatory aspects of a clinical project such as clinical protocol management, IRB management, safety reporting, rules for recruitment programs, seeking advice from FDA, trial master files, and training requirements.

This webinar will introduce attendees to the basics concepts and techniques of blinding of investigational drug products. It will also provide an understanding of the complexities of the work required to prepare blinded products for clinical trials.

This webinar will provide attendees an overview of the relevant statutes, including the Competition Act, Food and Drugs Act and relevant regulations and information about the existence and operation of Canadian advertising pre-clearance agencies. The rules around advertising and marketing health products will be explained using examples, and hot topics in advertising and marketing will be covered, including the use of social media, testimonials and endorsements.

This GAMP® 5 training/Webinar will discuss on the GAMP® software validation model and the defined process of GAMP® 5 as it applied to FDA software validation.