WEBINARS

 

Clinical Research Audits and Inspections Regulatory Compliance Training - Live Webinars, Recordings & CDs

How to Prepare a Standard Operating Procedure (SOP)?

webinar-speaker   Dr. Afsaneh Motamed Khorasani

webinar-time   60 Min

Product Id: 705131

This webinar will detail a step-by-step procedure on how to write a practical, effective and compliant Standard Operating Procedures (SOPs), review and revise SOPs and maintain compliance over the course of the SOP life-time.

Recording Available

* Per Attendee $299

 

Good Documentation Guideline (Chapter <1029> USP)

webinar-speaker   Dr. Afsaneh Motamed Khorasani

webinar-time   60 Min

Product Id: 705130

This webinar will familiarize participants with USP Chapter <1029> on good documentation guidelines. This session will wrap up the general concept and will provide information as to what needs to be documented in certain records.

Recording Available

* Per Attendee $299

 

Surviving an FDA Sponsor Inspection - Training for Success

webinar-speaker   Stephen Schwartz

webinar-time   105 Min

Product Id: 704516

This training program will review a case study derived from actual inspections wherein FDA performed a sponsor site inspection having already audited three of the investigator sites. FDA was aware from these site audits of potential serious noncompliance issues. The course will also discuss Sponsor/CRO/investigator relationship issues from these three site audits.

Recording Available

* Per Attendee $429

 

Medical Device Single Audit Program [MDSAP] Implementation & Participating Country Regulatory Processes: U.S., Canada, Brazil, Australia and Japan

webinar-speaker   Robert J Russell

webinar-time   90 Min

Product Id: 705370

This webinar will focus on the key regulatory requirements for medical devices for the participating MDSAP countries of U.S., Canada, Brazil, Australia and Japan. It will address key topics such as device classification, licensing pathways, medical device GMP, inspections, device labeling, license holder responsibilities and more.

Recording Available

* Per Attendee $299

 

Project Management for Auditors - Improving audit productivity for GCP, GMP and GLP

webinar-speaker   Laura Brown

webinar-time   60 Min

Product Id: 701982

This Project Management training for Auditors will help you understand how to apply project management principles to auditing to ensure efficient and effective quality assurance of drug development.

Recording Available

* Per Attendee $299

 

Risk Based Monitoring for GCP Compliance

webinar-speaker   Laura Brown

webinar-time   60 Min

Product Id: 705052

This Webinar will help you how to ensure that your data and supporting documentation are in the appropriate format to comply with regulatory authority inspection. Risk based monitoring can contribute to better oversight and more efficient use of resources of clinical studies.

Recording Available

* Per Attendee $299

 

The Most Serious FDA 483s - How to Avoid Them

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 702766

This webinar on avoiding serious FDA 483s will explain FDA's changed audit focus based on recent top 483 findings and provide practical tips on how to better prepare your company's internal audit program to avoid serious Form 483 observations.

Recording Available

* Per Attendee $299

 

FDA Compliance and Clinical Trial Computer System Validation

webinar-speaker   Carolyn Troiano

webinar-time   60 Min

Product Id: 705358

This webinar will discuss FDA requirements for clinical trial Computer System Validation (CSV) including System Development Life Cycle (SDLC) approach to validation. It will help attendees understand how to leverage the vendor and other external resources to apply the best industry practices and avoid potential pitfalls when validating a clinical trial system.

Recording Available

* Per Attendee $299

 

Processes & Effects of Immunogenicity to Biologics & the Screening Methodologies - 3 hour Virtual Training

webinar-speaker   Gwen Wise Blackman

webinar-time   180 Min

Product Id: 705019

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.

Recording Available

* Per Attendee $349

 

How to undergo an FDA Inspection Successfully

webinar-speaker   Marie Morin

webinar-time   90 Min

Product Id: 705170

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.

Recording Available

* Per Attendee $249

 

Computer System Validation and Part 11 Compliance

webinar-speaker   Joy McElroy

webinar-time   60 Min

Product Id: 705427

This webinar will discuss in detail the requirements of 21 CFR part 11 and updated European Annex 11 regulation including requirements for local, SaaS, and cloud hosting. It will also offer techniques to implement a computer system using risk-based validation to gain maximum productivity and reduce cost by as much as two thirds.

Recording Available

 

Electronic Data Integrity in a GxP Environment: Managing the Data Lifecycle for Compliance

webinar-speaker   Sarah Fowler Dixon

webinar-time   60 Min

Product Id: 705451

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.

Recording Available

 

Issues related to informed consent in clinical trials

webinar-speaker   Sarah Fowler Dixon

webinar-time   60 Min

Product Id: 705453

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

Recording Available

 

Trial Master File and Clinical Data Management Regulated by FDA

webinar-speaker   Carolyn Troiano

webinar-time   60 Min

Product Id: 705360

This FDA compliance training will cover in detail the new requirements for trial master files including documents related to clinical trials that are required to be prepared, collected and maintained as part of the TMF.

Recording Available

* Per Attendee $249

 

Auditing and Qualifying Suppliers and Vendors - An Effective Risk Based Approach

webinar-speaker   Joy McElroy

webinar-time   90 Min

Product Id: 704306

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.

Recording Available

* Per Attendee $299

 

Use of Electronic Health Record Data (EHR) in FDA regulated clinical investigations

webinar-speaker   Rachelle D Souza

webinar-time   60 Min

Product Id: 704906

This webinar will discuss FDA’s current recommendations on using electronic health records in prospective clinical investigations of human drugs, biologics, medical devices and combination products.

Recording Available

* Per Attendee $249

 

Phase I First-in-Man Studies: What is Special About How and Where These Trials are Conducted?

webinar-speaker   Charles H Pierce

webinar-time   90 Min

Product Id: 704842

This webinar will discuss the expectations of Phase 1 'First-in-Man' clinical studies, contrast the testing of pharmacokinetics and pharmacodynamics, differentiate safety testing in Phase 1 and 3 and describe the process of establishing the starting dose.

Recording Available

* Per Attendee $50

 

Compliance with the New EU Clinical Trial Regulation

webinar-speaker   Laura Brown

webinar-time   60 Min

Product Id: 705007

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.

Recording Available

 

Clinical Trial auditing - Identifying risks and building a more compliant and successful trial

webinar-speaker   Calin Popa

webinar-time   90 Min

Product Id: 701860

Learn how to successfully pass a clinical trial audit, how to prepare for it, where and how to identify the non compliance. Know FDA inspection strategy to identify areas of common deficiency.

Recording Available

* Per Attendee $249

 

Institutional Review Boards (IRBs): The Changing Landscape and the Effect on the Conduct of Clinical Research

webinar-speaker   Sarah Fowler Dixon

webinar-time   60 Min

Product Id: 703400

This clinical research training will explain the Institutional Review Board (IRB) models. It will discuss the regulatory framework for IRB review including 21 CFR 50, 56 and 45 CFR 46.

Recording Available

* Per Attendee $229

 

 

 

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