Clinical Research Documentation and Data Management Regulatory Compliance Training - Live Webinars, Recordings & CDs

This 3 hour virtual training will provide an overview of the concepts and types of immune responses elicited by biologics. The factors contributing to immunogenicity and impact on efficacy and safety will be identified. Validated screening and confirmatory methods that measure an immune response to a biologic during the various stages of development, clinical studies and post-approval surveillance will be discussed.

This webinar will discuss FDA requirements related to cloud computing. It will provide step-by-step recommendations for using 'clouds' from planning to reporting.

This webinar will cover effective and efficient ways to transition from paper to electronic records in a regulated environment. It will address compliance issues, complexity in decision making and implications specific to the pharmaceutical industry.

This webinar will review the CTD format requirements including documentation and technical requirements for an eCTD submissions. It will help attendees prepare for implementing the FDA upcoming mandates on e-submissions.

This webinar will discuss best practices for preparing for an international announced inspection as well as how to be always prepared for those in the US who may be inspected at any time. It also discusses the various roles of the persons who will be assisting during the inspection and suggests how to organize support personnel to aid in keeping the inspection going smoothly and identify and address issues before FDA sees them.

Buying software is a fact of life for most companies. There is fierce competition in the market, with multiple software vendors trying to convince to buy their product. How do you determine whether to buy the software or having it built in house? Or which vendor to choose? And if you buy something, how do you determine whether to have it hosted? And are there any regulations that apply to this software? And if so, what are they?

This webinar will provide an understanding of the data integrity and data lifecycle within the GxP environment. Attendees will learn best practices to comply with the current regulations and industry standards for electronic data integrity throughout the data lifecycle.

This webinar will discuss some common literacy trends, issues with consent documents and tips to enhance the consent process.

This webinar will focus on the specific types of writing responsibilities available in industry. It will help attendees understand the medical writing profession and in determining if medical writing or technical writing is a good fit for each of them.

This webinar will cover background information and history of clinical research and drug development, followed by review of the federal regulations, International Council for Harmonisation (ICH), and Good Clinical Practices (GCP) that apply to clinical research.

This webinar will focus on most trustworthy open access resources. It will also provide tips on how to gain access to hard-to-find materials by paying high subscription or membership fees.

By attending this webinar, you will gain a better understanding of the regulatory expectations for an effective and GMP-compliant training system. In this webinar your instructor will share with you what he has learned over the past decade of developing and delivering effective GMP training programs as well as from his 25 plus years of working in the Life Science industries.

This 90-minute training program is designed for people tasked with performing external audits for their organizations. It is also for those tasked with developing, maintaining and/or improving programs for manufacturing facilities. This includes individuals that have quality management system responsibilities for making general improvements in their organization’s performance specifically related to equipment, processes and documentation.

This 510(k) training will discuss the submission process and the contents required by the FDA for a successful 510(k) submission.

This webinar will provide an essential understanding to help with compliance with the new regulation and associated implementing acts and other texts for carrying out clinical trials in the EU.

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 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 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 FDA documentation webinar will explain the regulatory expectations for, and the proper design and maintenance of effective and compliant standard operating procedures (SOPs).

This course will present attendees with a clear understanding of the new processes and requirements for EU sponsors of clinical trials as the new regulation is published, rolled-out and implemented by the Member States, the European Medicines Agency and the European Commission.