WEBINARS

 

Clinical Regulatory Compliance Training - Live Webinars, Recordings & CDs

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

 

FDA Regulatory Actions: It's Not Just about Warning Letters

webinar-speaker   Fredric Richman

webinar-time   60 Min

Product Id: 703344

This training will outline the possible consequences for failing to promptly and adequately correct significant violations related to cGMPs, new drugs or devices, labeling or other regulatory issues resulting in advisory, administrative and judicial actions.

Recording Available

* Per Attendee $229

 

FDA Premarket Review of New and Modified Tobacco Products

webinar-speaker   Azim Chowdhury

webinar-time   60 Min

Product Id: 703127

This training on FDA regulatory requirements for tobacco products will focus on the premarket review of new and modified tobacco products. It will also discuss the impact of FDA deeming regulation for of e- cigarettes and novel tobacco products on premarket authorization requirements.

Recording Available

* Per Attendee $229

 

How to file a 510(k) when your device is (or contains) software

webinar-speaker   Cheryl Wagoner

webinar-time   75 Min

Product Id: 703366

The Webinar will discuss the structure and level of detail required in filing a 510(k) when a medical device is software or contains software.

Recording Available

* Per Attendee $299

 

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

 

Are you prepared for a regulatory audit from FDA or any other regulatory body?

webinar-speaker   Philip Russ

webinar-time   90 Min

Product Id: 703355

This FDA audit training provides an overview of the audit readiness process from internal evaluation of your quality systems to the logistics of the audit itself; with key emphasis placed on equipping you and your team with the skills needed to present expert testimony during interviews with regulators.

Recording Available

* Per Attendee $229

 

Major Changes to the EU Clinical Trials Regulation: What is Required for Compliance

webinar-speaker   Laura Brown

webinar-time   60 Min

Product Id: 703336

This webinar will help Sponsors, CROs and study sites running clinical trials in the EU and internationally; understand the important, updated compliance requirements concerning the new EU Clinical Trials Regulation due to be enacted in 2016 and which will replace the 2001 Clinical Trials Directive (CTD) (2001/20/EC).

Recording Available

* Per Attendee $229

 

Regulatory Documentation for Clinical Trials

webinar-speaker   Adam Ruskin

webinar-time   60 Min

Product Id: 703329

This clinical research compliance training will explain in detail the list of required regulatory documentation for clinical trials for industries such as pharmaceutical, biotechnology, medical devices and diagnostics. It will also review many of the documents in terms of required content and structure.

Recording Available

* Per Attendee $229

 

Essential Do's and Don'ts for Navigating a Successful 505(b)(2) Drug Application

webinar-speaker   Thomas Reilly

webinar-time   60 Min

Product Id: 703314

This FDA New Drug Approval process training will provide attendees with the knowledge and skills needed to develop a successful 505 (b)(2) program.

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

 

Understanding the FDA ''Refuse to Accept'' guidance to avoid administrative rejection of your 510(k)

webinar-speaker   Cheryl Wagoner

webinar-time   60 Min

Product Id: 703235

The webinar will familiarize participants with the FDA's Refuse to Accept Policy for medical device 510(k)’s and help you ensure that your 510(k) application is not rejected for lack of administrative completeness.

Recording Available

* Per Attendee $229

 

Medical Foods: Understanding what Constitutes a Medical Food for FDA Regulatory Purposes and Strategies for Successfully Commercializing such Products in the U.S.

webinar-speaker   Karl M. Nobert

webinar-time   90 Min

Product Id: 702508

This training on medical foods will provide an introduction to FDA’s regulation of medical products, assist you in identifying when it may be appropriate to market a product as a medical food; recommend strategies for marketing such products; and summarize recent FDA enforcement actions in the area to help companies mitigate the risk of potential Agency enforcement action.

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

 

US FDA 510(k): Best Practices for 510(k) Preparation and Submission

webinar-speaker   David Lim

webinar-time   60 Min

Product Id: 703218

This webinar will discuss best practices for premarket notification [510(k)] preparation and submission compliant with FDA's eCopy and Refuse to Accept (RTA) Policy requirements.

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

 

Walking the Minefield of Clinical Trial Budgets and Contracts; A Primer for Research Managers

webinar-speaker   Robert Romanchuk

webinar-time   90 Min

Product Id: 702373

This webinar will provide a basic understanding of regulations and statutes that people involved in the clinical research contract negotiation process must be aware of. You will learn how to negotiate for and create federally complaint agreements and thus avoid the risk associated with violations.

Recording Available

* Per Attendee $229

 

2-in-1 Virtual Seminar: FDA's Strategic Priorities and Supplier Control Requirements

webinar-speaker   John E Lincoln

webinar-time   3.5 hrs

Product Id: 703052

This virtual seminar will start by evaluating important areas for regulated companies to focus in 2013-2014, based on the U.S. FDA’s recent "Strategic Priorities" initiative. The second-half of the session will discuss how FDA's global initiatives affect supplier chain management and vendor audits and how you can prepare to address them.

Recording Available

* Per Attendee $499

 

Coping with a Difficult Compliance Officer when Responding to a 483, Warning Letter, Import Alert or Recall

webinar-speaker   Marc Sanchez

webinar-time   60 Min

Product Id: 703044

This webinar on handling FDA inspectors will discuss practical tips to cope with a difficult FDA compliance officer or inspector. You will learn how to wiggle out of complicated situations, make legal arguments and challenges to the FDA agent and use meeting requests and other tools to ease tensions.

Recording Available

* Per Attendee $229

 

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

 

 

 

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