Live Webinar Project Management for Computer Systems Regulated by FDA

By: Carolyn Troiano ,ERP Project Manager/FDA Compliance Consultant.

Project management principles can be used to ensure that all efforts to develop, configure, implement, test, validate and maintain a computer system is compliant.specific in

  • 23-August-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

Live Webinar Implementing Effective Regulatory Compliance

By: Charles H Paul ,President at C. H. Paul Consulting, Inc.

This webinar will take the participant on a journey that begins with an organizational clean slate and builds all of the key pieces that are

  • 23-August-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minute

Live Webinar Design Control Principles for Medical Device Manufacturers

By: Jeff Kasoff ,FDA Speaker, Quality and Regulatory Consultant.

Prior to introduction of a new device, or even a modified design for an existing device, a systematic process must be followed

  • 28-August-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minute

3-hour Webinar:NAFTA 2.0: Current State of Renegotiations and How It Could Affect You

By: Douglas Cohen ,Senior Manager for Global Trade and Contracts, Worldwide Trade and Legal Associates.

  • 30-August-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 180 Minutes

Regulatory Perspectives on Pharmacogenomics: A Review of Key Issues Faced by FDA

By: Angela Bazigos ,CEO Touchstone Technologies Silicon Valley.

Submission of pharmacogenomics data as part of a drug or biologic submission, impacts the approval of the submitted product. Complying with FDA requirements on the

  • 30-August-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

Live Webinar Best Practices for Investigating Deviations Write-Ups and Management

By: Danielle DeLucy ,Principal/Owner, ASA Training & Quality Consulting, LLC.

This webinar will help attendees understand the fundamental investigation steps and skill sets. Key focus will be placed on identification and initial reporting of deviations,

  • 31-August-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minute

Live Webinar Use of Electronic Health Records (EHR) in FDA Regulated Clinical Investigations

By: Rachelle D’Souza ,CEO and President, Regulatory Heights Inc.

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.

  • 05-September-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minute

Live Webinar Understanding European Filing and Registration Procedures for Drug Approval

By: Peggy J. Berry. ,MBA, RAC,President & CEO, Synergy Consulting (Ex-FDA Official).

How to choose the appropriate pathway to drug approval in the EU

  • 06-September-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minute

Live Webinar Regulatory Submissions all Part of 510K

By: JERRY DALFORS ,Principal, JD Technologies.

FDA BRIEFING Documents

  • 06-September-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

Live Webinar Packaging and Labelling for Commercial and Clinical Products - 2017

By: Peggy J. Berry. ,MBA, RAC,President & CEO, Synergy Consulting (Ex-FDA Official).

Real-life case studies and dos/don’ts for packaging and labeling for commercial and clinical products will also be discussed.

  • 07-September-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

Live Webinar Drug Discovery & Development: the FDA Way

By: Angela Bazigos ,CEO Touchstone Technologies Silicon Valley.

The Drug Discovery and Development (but also the biologics and medical device) process is a very complex process with every participant focusing on their particular

  • 08-September-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

Live Webinar DHF, DMR, DHR, and Technical File / Design Dossier – And the New EU MDR

By: John E Lincoln ,Principal of J. E. Lincoln and Associates LLC.

Requirements for the U.S. FDA's DHF per the CGMPs, 21 CFR 820.30 and the almost now identical ISO 13485:2016 Design and Development File -- including

  • 12-September-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

Live Webinar : Compliant Use of Cloud Technologies in the Life Sciences

By: Joseph Franchetti ,FDA Quality and Regulatory Compliance Specialist.

This presentation will highlight the concerns of industry and give you the confidence you need to maintain a cloud based system in a regulated environment

  • 14-September-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

3-hour webinar: Training & Development in the Life Sciences

By: Charles H Paul ,President at C. H. Paul Consulting, Inc.

Webinar Includes : All the training handouts , certificate ,Q/A and 3 Hrs Live Webinar

  • 14-September-2017| 12:00 PM EDT | 9:00 AM PDT | 11:00 PM CDT Duration 180 Minutes

Mobile Medical Apps (Is It a FDA Regulated Device) and Cybersecurity

By: Charles H Paul ,President at C. H. Paul Consulting, Inc.

Cybersecurity is very important for moblile apps. The FDA requirements for cybersecurity in the app design will be explained

  • 19-September-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minute

Live webinar: International Letters of Credit

By: Jan Seal ,International Trade Consultant.

A letter of credit is one method of payment used in international trade transactions.

  • 19-September-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

Reporting HIPAA Breaches — When health information is compromised, who must be notified, how, and when

By: Jim Sheldon-Dean ,Principal and Director of Compliance Services, Lewis Creek Systems, LLC.

how to create the right breach notification policy for your organization and how to follow through when an incident occurs.

  • 19-September-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

3 hours Webinar: Best Practices in Complaint Management: Complaint Handling in Compliance with FDA and ISO Regulations

By: Jeff Kasoff ,FDA Speaker, Quality and Regulatory Consultant.

Webinar Includes : All the training handouts , certificate ,Q/A and 3 Hrs Live Webinar

  • 20-September-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 180 Minutes

Live Webinar Development and Audit of Complaint Handling and MDR Processes

By: Jeff Kasoff ,FDA Speaker, Quality and Regulatory Consultant.

Application of risk management to complaint handling program

  • 21-September-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minute

Live Webinar Regulatory Submissions all Part of CMC

By: JERRY DALFORS ,Principal, JD Technologies.

  • 26-September-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

Live Webinar Qualification of contract manufacturer organizations based on practical experience

By: Edwin Waldbusser ,Regulatory Consultant, Med Device Advisors.

Attendees will receive “A 6 page Pre-Audit Questionnaire and a 25 page CMO audit form”

  • 27-September-2017| 02:00 PM EDT | 09:00 AM PDT | 11:00 AM CDT Duration 60 Minute

3-hr Webinar : Untangling the FMLA, ADAAA, GINA, and Workers Compensation Laws

By: Susan Fahey Desmond ,Attorney/Principal with Jackson Lewis PC.

Webinar Includes : All the training handouts , certificate ,Q/A and 3 Hrs Live Webinar

  • 27-September-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 180 Minutes

How to Evaluate Payroll Provider Vendors and Minimize Implementation Nightmares!

By: Margie Pacheco Faulk ,Sr HR Consultant, HR Compliance Solutions.

All companies with 50 or more employees must ensure compliance with federal, state and local regulations. It is difficult to navigate the employment law reporting

  • 27-September-2017| 12:00 PM EDT | 09:00 AM PDT | 11:00 AM CDT Duration 90 Minute

Risk Based Approach to 21 CFR 11 ER/ES & Validation of Computer Systems

By: Angela Bazigos ,CEO Touchstone Technologies Silicon Valley.

This Hands-On course will provide the attendees with both a strategic and a tactical understanding of how CSV fits into all aspects of the Life

  • 27-September-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

Live Webinar Management Controls Under FDA QSR and ISO 13485

By: Jeff Kasoff ,FDA Speaker, Quality and Regulatory Consultant.

  • 02-October-2017| 1:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minute

Live Webinar Implementing a Change Control Quality System Successfully

By: Danielle DeLucy ,Principal/Owner, ASA Training & Quality Consulting, LLC.

  • 05-October-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minute

3 Hour Webinar: How the FDA is Trained on Medical Device Inspections

By: Angela Bazigos ,CEO Touchstone Technologies Silicon Valley.

This webinar will examine the training that FDA inspectors receive on five regulations for inspecting medical device firms

  • 10-October-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 180 Minutes

Live Webinar Preventing Medical Device Recalls

By: Charles H Paul ,President at C. H. Paul Consulting, Inc.

In a recent study, the FDA has reported a 95% increase in medical device recalls

  • 12-October-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minute

Live Webinar : Software / Firmware Verification and Validation to Meet Regulatory Requirements

By: John E Lincoln ,Principal of J. E. Lincoln and Associates LLC.

Software has become pervasive in medical devices themselves, and in the controlling, running and monitoring of medical product processes, whether they be in the pharmaceutical,

  • 25-October-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes
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