Clinical Trials Regulatory Compliance Training - Live Webinars, Recordings & CDs

This Trial Master File training will review the essential elements of a TMF for clinical trials. The activities of set-up, maintenance, and monitoring will be discussed using check-lists and case studies to highlight common deficiencies and potential solutions.

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 Sunshine Act reporting webinar will discuss new requirements for manufacturers of healthcare products related to report of certain payments and items of value given to physicians and teaching hospitals. It will discuss the reporting format, exemptions and timeline for compliance and practical solutions to most common situations prevalent between sponsors and investigators.

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.

Join this webinar which will discuss current, expert, and applicable knowledge about the responsibilities, functions, and management of SAE reporting and medical safety for a clinical trial. The procedures for SAE reporting will be discussed which should be contained in company SOPS and well organized with regard to staff assignments and responsibilities before a trial begins to assure all responsibilities are covered.

This webinar will discuss good clinical practice core principles and project management strategies applicable to financial aspects of clinical research during new biomedical product development process. Strategies and best practices to mitigate fiscal risks in clinical trials will be discussed i.e. coverage analysis, cost estimation, budgeting and billing Compliance.

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.

In this revised ICH GCP guideline on budgeting and contracts for clinical trial webinar will discuss the impact of changes in ICH GCP E6 R2 on investigator, site, sponsors CROs roles and responsibilities and the impact of clinical trial conducts and organizational practices along with evaluate solutions/applicability/modifications of organizational SOPs, processes, procedures and staff training; and discuss opportunities for implementing the revised guideline.

This webinar will teach attendees best practices for building a sustainable vendor qualification program for FDA regulated industries. It will discuss common pitfalls to avoid when qualifying vendors.

This Good clinical research practices and auditing (GCP) webinar will teach how to get rid of challenges related to clinical practice in particular to data quality and regulatory risk proactively, with the goal of strengthening auditing programs and ensuring compliance with risk-based techniques.

In this webinar attendees will gain current, expert, and applicable knowledge about the responsibilities, functions, and management of SAE reporting and medical safety for a clinical trial.

The course is designed to review critical elements of the new regulations and is suitable for for clinical, regulatory and quality leaders. The course is suitable to anyone who is new to Medical Devices, in addition to those who would like to further their working knowledge of current requirements.

Attendees that need to perform bioavailability (BA) and bioequivalence (BE) studies for INDs, NDAs or for NDA supplements should attend this training. They will learn the requirements of such studies, per 21 CFR 320 and all other relevant regulatory documents.

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 introduce attendees to key components of a computerized system validation master plan and set out the requirements for compliance as per FDA’s 21 CFR 11. It will detail several aspects such as requirements, design, configuration specifications, validation testing, procedures/archival/traceability, and best practices for system decommissioning/retirement as well.

This webinar will cover FDA’s current thinking on QRM and Guidance for Industry - Q9 Quality Risk Management, provide information to help understanding of QRM concepts, and applications. In addition, brief review of how ICH Q8, Q9, and Q10 work in coherence throughout product lifecycle.

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.