WEBINARS

 

Clinical Regulatory Compliance Training - Live Webinars, Recordings & CDs

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

 

Additional Medicare Reporting Under the Sunshine Act Rules of 2013

webinar-speaker   Mukesh Kumar

webinar-time   60 Min

Product Id: 702998

This webinar will provide a summary of the additional medicare reporting requirements under the Sunshine Act rules, and tips for assuring compliance to protect both the manufacturers of FDA regulated products and physicians.

Recording Available

* Per Attendee $229

 

Global Medical Device Laws and Regulations: US, EU, and Canada

webinar-speaker   David Lim

webinar-time   90 Min

Product Id: 702842

This training on global medical device regulations will discuss the regulatory framework for medical devices in US, EU and Canada. It will outline systematic methods to identify and meet regulatory requirements and streamline the regulatory process in these countries.

Recording Available

* Per Attendee $50

 

FDA's Revised 510(k) Process: The Medical Device Professional's Guide to Successfully Preparing 510(k) Submissions and Regulatory Compliance

webinar-speaker   Chris Cook

webinar-time   70 Min

Product Id: 702963

This medical device 510(k) training will help you understand the basics of 510(k) submissions and discuss how to develop and execute an approval strategy ensuring the fastest possible path to market.

Recording Available

* Per Attendee $229

 

The Sunshine Act Final Rule

webinar-speaker   Mark Gardner

webinar-time   120 Min

Product Id: 702825

This session will discuss in detail the Final Rule for the Physician Payment Sunshine Act, its impact and how to prepare for it. You will learn about reporting, certification and registration deadlines and what specifically needs to be reported or provided to CMS.

Recording Available

* Per Attendee $249

 

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

 

Asian Medical Device Laws and Regulations: China, Hong Kong, Japan and Korea

webinar-speaker   David Lim

webinar-time   90 Min

Product Id: 702841

This training on Asian medical device regulations will discuss the regulatory framework for medical devices in China, Hong Kong, Japan and Korea. It will outline systematic methods to identify and meet regulatory requirements and streamline the regulatory process in these Asian countries.

Recording Available

* Per Attendee $229

 

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

 

3-hr Virtual Seminar - The Interface Between Medicare and Medicaid, Anti-kickback Statute (AKS), Stark II and the Federal Civil False Claims Act (FCA): Is your Organization at Risk?

webinar-speaker   William Mack Copeland

webinar-time   3 hrs

Product Id: 702787

This healthcare compliance training will explain how the FCA, the AKS and the Federal Physician Self Referral Law (Stark II) work, the prohibitions, exceptions and safe harbors. It will review recent examples to show how they interface and can potentially impact you/ your organization.

Recording Available

* Per Attendee $399

 

Dispelling the Myths About Clinical Standardization

webinar-speaker   Kit Howard

webinar-time   90 Min

Product Id: 702494

This 90-minute webinar will examine the many myths that get in the way of clinical standards adoption and demonstrate how complying with required standards benefits both the FDA and sponsors.

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

 

Implementation and Utilization of Standard Operating Procedures (SOPs) at the Clinical Research Site

webinar-speaker   Christine Hegi

webinar-time   60 Min

Product Id: 702651

This webinar will assist clinical research personnel in developing/acquiring SOPs for their site. You will learn how to create a compliant but user–friendly set of SOPs that can pass regulatory audits and also be a useful tool for the site staff.

Recording Available

* Per Attendee $229

 

Using Electronic and Digital Signatures in Regulated Environments

webinar-speaker   Dr. Ludwig Huber

webinar-time   75 Min

Product Id: 702672

This webinar will familiarize you with FDA requirements for electronic and digital signatures, and the agency's inspection and enforcement practices. Particpants will recieve complimentary hand-outs for easy implementation.

Recording Available

* Per Attendee $229

 

Optimal Clinical Supply Planning for Global Drug Development

webinar-speaker   Vladimir Shnaydman

webinar-time   60 Min

Product Id: 702552

This webinar will discuss how to manage supply chain risk to optimize clinical trial supply and also manage demand side requirements, risk of stock out, cost management etc using novel tools and technologies.

Recording Available

* Per Attendee $229

 

Modifications to a Cleared Device - FDA's 510(k) Guidance

webinar-speaker   Daniel O Leary

webinar-time   90 Min

Product Id: 702595

This 90-minute webinar will explain FDA's 1997 guidance on 510(K) for device modifications and show how to integrate the evaluation into your design change program. The webinar uses numerous Warning Letters to illustrate the points, and helps you learn from others.

Recording Available

* Per Attendee $50

 

The Informed Consent Process at the Investigator Site- Who decides if it is adequate and GCP compliant, Ethics Committee, Sponsor, or Investigator?

webinar-speaker   Stephen Schwartz

webinar-time   75 Min

Product Id: 702538

This webinar will discuss the role of the ethics committee, the trial sponsor and investigator in providing an adequate Informed Consent (IC). It will discuss challenges and practical limitations in ensuring your informed consent is GCP compliant.

Recording Available

* Per Attendee $229

 

Interpreting FDA's New Guidance Document on Risk-based Monitoring

webinar-speaker   Moe Alsumidaie

webinar-time   60 Min

Product Id: 702485

This webinar will train you on interpreting FDA's new guidance document on risk-based monitoring. It will include a case study demonstration on how any biopharmaceutical, medical device, and CRO could leverage the applications of breakthrough techniques to implement risk-based monitoring.

Recording Available

* Per Attendee $229

 

When does GCP Non-compliance at an investigator site compromise a regulatory submission? To File Or Not To File - that is the question!

webinar-speaker   Stephen Schwartz

webinar-time   75 Min

Product Id: 702519

This webinar will help you manage the risks associated with GCP non-compliance at a pivotal investigator site. The training will follow a case-study approach to help you learn how to determine investigator non-compliance and guide you in deciding whether or not to file the efficacy study data in a regulatory application.

Recording Available

* Per Attendee $229

 

Investigator Initiated (Sponsored) Trials - ISSs

webinar-speaker   Charles Laudadio

webinar-time   60 Min

Product Id: 702420

This webinar will cover definitions, responsibilities, regulatory requirements and strategies to conduct Investigator Initiated (Sponsored) Trials - ISSs. It outlines the processes a company or investigator must undertake to be able to conduct such a clinical research study in humans.

Recording Available

* Per Attendee $229

 

 

 

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