2017 workshop eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada (COM)

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

An Interative Workshop Presented BY WCS & Peggy J. Berry, MBA, RAC, (Synergy Consulting)

Course"eCTD Submissions of IND and NDA/BLA to the US FDA, EU and

  • 02-November-2017  To 03-November-2017 - Philadelphia, PA

Live Webinar CAPA, Failure Investigation and Root Cause Analysis to Meet FDA Expectations

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

Defined Failure Investigation and Root Cause Analysis is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management

  • 12-July-2017

Live Webinar The Requirements and Responsibilities of a HIPAA Security/Privacy Officer

By: Howard Jones ,President of HJones & Associates LLC.

Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar

  • 26-April-2017

Live Webinar Audit – An Essential Tool for Continuous Improvement

By: Susanne Manz ,Quality and Compliance Expert / Auditor for Medical Devices, Manz Consulting, Inc..

Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar

  • 18-April-2017

Live Webinar Quality System Management Effectiveness

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

Webinar Includes : All the training handouts , certificate ,Q/A and 60 mins Live Webinar

  • 12-April-2017

An Introduction to the New EU Medical Device Regulation

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

Webinar Includes : All the training handouts , certificate ,Q/A and 60 mins Live Webinar

  • 16-May-2017

Live Webinar Integration of Enterprise Requirements Planning (ERP) and Legacy Systems in an FDA-Regulated Environment

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

Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar

  • 11-May-2017

Creation of DHFs, DMRs, and DHRs utilizing the principles of Lean Documents and Lean Configuration

By: José Mora ,Principal Consultant.

Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar

  • 02-May-2017

Live Webinar Risk Management - Principles of Lean Documents and Lean Configuration

By: José Mora ,Principal Consultant.

Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar

  • 08-June-2017

Live Webinar FDA vs Health Canada

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

Webinar Includes : All the training handouts , certificate ,Q/A and 60 mins Live Webinar

  • 13-June-2017

Live Webinar Implementing a process for the successful Technology Transfer of drug products

By: Steven Laurenz ,Principal Consultant, Biophia Consulting Inc.

This training will introduce the concepts associated with implementing a carefully defined technical and business governance programs along with clearly defined R&D to site transfer

  • 21-June-2017

Live Webinar Document Control for Start-ups: Cost-Efficient and Compliant

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

Document control can be a time- and paper-consuming process. To your start-up, time is a valuable commodity. So is money.

  • 28-June-2017

Live Webinar Medical Device Trends for Computer Systems Regulated by FDA

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

Webinar Includes : All the training handouts , certificate ,Q/A and 60 mins Live Webinar

  • 14-June-2017

Live Webinar Equipment Validation, Tracking, Calibration and Preventive Maintenance

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

FDA and EU regulations require that firms have a program for the calibration and maintenance of test and measurement equipment

  • 23-June-2017

Live Webinar Process Validation: Principles and Protocols

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

This webinar explains the regulatory requirements for process validation

  • 06-July-2017

Live Webinar Controlled Document System for a Life Sciences Manufacturing Plant - Principles of Lean Documents and Lean Configuration

By: José Mora ,Principal Consultant.

All life science businesses are required to maintain their Quality Management System (QMS) processes in a state of control, via controlled documents and objective evidence

  • 11-July-2017

Live Webinar Management Controls Under FDA QSR and ISO 13485

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

  • 02-October-2017

Live Webinar Good Documentation Practices for FDA-Regulated Computer System Validation

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

Webinar Includes : All the training handouts , certificate ,Q/A and 60 mins Live Webinar

  • 19-July-2017

Live Webinar FDA Regulation, 3D Printing and Medical Devices

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

Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar

  • 19-July-2017

Live Webinar Regulatory Submissions all Part of CMC

By: JERRY DALFORS ,Principal, JD Technologies.

  • 26-September-2017

Live Webinar Implementing a Change Control Quality System Successfully

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

  • 05-October-2017

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

Live Webinar Biosafety and Blood borne Pathogen Safety in the Lab

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

This webinar will review the regulations and guidelines recommended by the Centers for Disease Control and Prevention

  • 17-August-2017

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

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
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