WEBINARS

 

FDA Good Clinical Practice Regulatory Compliance Training - Live Webinars, Recordings & CDs

Clinical Trial Liability Lawsuits

webinar-speaker   Jonathan Mcdermed

webinar-time   60 Min

Product Id: 703645

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.

Recording Available

* Per Attendee $229

 

Writing and Implementing Statistical Analysis Plans (SAPs) - Domestic and International Guidance under ICH E9

webinar-speaker   Rita Hanover

webinar-time   90 Min

Product Id: 702783

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.

Recording Available

* Per Attendee $50

 

Deviations: What are they? Do you need to report?

webinar-speaker   Sarah Fowler Dixon

webinar-time   60 Min

Product Id: 702394

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.

Recording Available

* Per Attendee $229

 

Regulatory Perspectives of Clinical Project Management: Meeting FDA Requirements for Clinical Trials

webinar-speaker   Mukesh Kumar

webinar-time   90 Min

Product Id: 702241

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.

Recording Available

* Per Attendee $229

 

Major Changes to Clinical Trials in Europe - The New EU Clinical Trials Regulation - What Can We Expect for Compliance?

webinar-speaker   Laura Brown

webinar-time   60 Min

Product Id: 703695

This webinar will help ensure attendees are familiar with new regulations for running clinical trials in Europe. It will help them prepare to implement the new requirements efficiently while elaborating how clinical trials will be authorized in the future. The instructor will also detail the authority proffered to EU regulators to perform inspections of all clinical trials registered in the EU, whether they are conducted within the EU or internationally in other emerging markets.

Recording Available

* Per Attendee $229

 

Packaging and Labeling of Clinical Supplies

webinar-speaker   Donald Levine

webinar-time   90 Min

Product Id: 703658

This comprehensive study of the clinical supply process will address increasing efficiency in packaging and labeling. It will also detail compliance requirements that have to be met in the process. Participants will enjoy the opportunity to train under an industry expert and understand solutions for some of the most common challenges in the process.

Recording Available

* Per Attendee $229

 

Ensuring Legally-Effective Informed Consent: Basic to Advanced Issues for Investigators and IRBs

webinar-speaker   George Gasparis

webinar-time   90 Min

Product Id: 703562

This webinar on informed consent will review the regulatory requirements to ensure that legally-effective consent is obtained for enrollment of subjects in human research regulated by the Department of Health and Humans Services (HHS) and/or the Food and Drug Administration (FDA). You will gain an understanding of not only the basic requirements, but also several challenging areas to ensure legally-effective consent.

Recording Available

* Per Attendee $229

 

Adverse Event Reporting Requirements for Dietary Supplements and OTC Drugs

webinar-speaker   Mukesh Kumar

webinar-time   90 Min

Product Id: 703422

This webinar will discuss regulatory requirements for adverse event reporting for dietary supplements and OTC products. It will explain the similarities and differences in reporting adverse events for dietary supplements and OTC products and will also discuss trends in FDA audit for these products.

Recording Available

* Per Attendee $229

 

How to respond to GXP (GCP, GLP, GMP, GPV) Inspection and Audit Findings using Correction and Preventative Action (CAPA)

webinar-speaker   Laura Brown

webinar-time   60 Min

Product Id: 703160

This webinar will help attendees understand how to respond to inspection and audit findings using CAPA (Correction and Preventative Action) for all types of GXP inspections and audit (eg GCP, GLP, GMP, GPV).

Recording Available

* Per Attendee $229

 

Managing the Trial Master File - Considerations for Moving to Electronic TMFs

webinar-speaker   Eldin Rammell

webinar-time   60 Min

Product Id: 703256

This clinical compliance training will review what issues one needs to consider if one’s organization is thinking about introducing an IT solution for the management of trial master file content. Attendees will gain an understanding of how to comply with the regulatory requirements that are pertinent to the maintenance of the TMF and how to choose efficient supporting TMF processes.

Recording Available

* Per Attendee $229

 

Understanding and Interpreting the EMA Reflection Paper on GCP Compliance in Relation to Trial Master Files (paper and/or electronic) for Management, Audit and Inspection of Clinical Trials

webinar-speaker   Eldin Rammell

webinar-time   60 Min

Product Id: 703281

This training will give attendees an insight into the interpretation of GCP regulations by the European Medicines Agency (EMA) as they relate to the management of trial documents, focusing especially on clarification within the paper on disputed and ambiguous areas of trial master file (TMF) management.

Recording Available

* Per Attendee $229

 

Archiving Clinical Trial Documents - Understanding Regulatory Requirements for Paper and Electronic Records

webinar-speaker   Eldin Rammell

webinar-time   60 Min

Product Id: 703265

This webinar will cover regulatory requirements for archiving clinical trial documents, both paper and electronic records. It will focus on the key components of a digital preservation strategy to ensure the ongoing retrievability and accessibility of clinical trial electronic records.

Recording Available

* Per Attendee $229

 

Essentials of the Trial Master File for Pharmaceutical, Biotech, Medical Device and Diagnostics Industries and Paper vs. Electronic TMFs - Which is Correct for My Program

webinar-speaker   Adam Ruskin

webinar-time   90 Min

Product Id: 703210

This training on clinical compliance will focus on the requirements of trial master file (TMF) for pharmaceutical product, biotech, a medical device or a diagnostic product. Attendees will learn the best practices to ensure that the TMF is ready for inspection by the regulatory authority.

Recording Available

* Per Attendee $229

 

Clinical Trial Billing - Building a Compliant Process that Works!

webinar-speaker   Robert Romanchuk

webinar-time   90 Min

Product Id: 702426

This webinar will show how you can devise a clinical trial billing system/ process to manage the billing of clinical trial charges in compliance with Federal rules and regulations.

Recording Available

* Per Attendee $50

 

3-hr Virtual Seminar - China: Compliance Processes for Life Science Products (Company Establishment, Clinical Trials, Registrations, Renewals and Supply Chain Considerations)

webinar-speaker   Robert J Russell

webinar-time   3 hrs

Product Id: 702548

This 3 hour virtual seminar on China regulatory compliance processes for life science products will discuss the regulatory structure and requirements for compliance against China’s CFDA regulations for Pharmaceuticals, Medical Devices, Biologics and Combination Products.

Recording Available

* Per Attendee $849

 

Essential Last Minute Preparation for an Imminent FDA Inspection

webinar-speaker   Chris Cook

webinar-time   60 Min

Product Id: 703004

This webinar on preparing for FDA inspections will present simple but powerful tools, with real world examples on how to prepare for an impending FDA inspection. You will learn what essential last minute preparation activities can be done and others that should be avoided.

Recording Available

* Per Attendee $229

 

Creating a Quality Assurance Program for (Clinical) Research Sites

webinar-speaker   Amanda Shepler

webinar-time   60 Min

Product Id: 702855

This clinical research QA training will provide practical advice for clinical research sites on when and how to get started with building their quality assurance program. A table of contents of the most critical SOPs will be provided.

Recording Available

* Per Attendee $149

 

3-hr Virtual Seminar: Annual ICH GCP Refresher Course

webinar-speaker   Christine Hegi

webinar-time   3 hrs

Product Id: 702652

This 3-hr virtual seminar will offer a comprehensive ICH GCP training for all healthcare professionals involved in clinical research.

Recording Available

* Per Attendee $399

 

Dietary Supplement Adverse Event Reporting and Recordkeeping Requirements under the Dietary Supplement and Nonprescription Drug Consumer Protection Act

webinar-speaker   Katherine Giannamore

webinar-time   60 Min

Product Id: 702756

This webinar on dietary supplement adverse event reporting will explain the requirements under federal law as to when serious adverse event reports must be submitted to the FDA, what information and when it must be submitted. In addition, it will highlight the recordkeeping requirements under the law pertaining to all adverse event reports.

Recording Available

* Per Attendee $229

 

How to Prevent or Handle Protocol Deviations and Violations to be GCP and Regulatory Compliant?

webinar-speaker   Charles H Pierce

webinar-time   90 Min

Product Id: 701760

This GCP compliance training will discuss the regulatory requirements for handling protocol deviations and violations and the importance of documentation that is required. The presenter will provide specific examples and proven tips for handling instances of protocol violations.

Recording Available

* Per Attendee $229

 

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