2 day seminar : Marketing, Advertising and Promotion of Pharmaceuticals and Medical Devices

By: David R Dills , Regulatory Affairs & Compliance Consultant.

Course "Marketing, Advertising and Promotion of Pharmaceuticals and Medical Devices" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full

  • 30-June-2017  To 01-July-2017 - Boston,MA

2 Day Seminar Preparing for and Managing Successful FDA Inspections

By: David R Dills , Regulatory Affairs & Compliance Consultant.

The course will go through what typically goes on during an FDA Inspection and will then cover how to prepare for, host and follow up

  • 13-July-2017  To 14-July-2017 - Boston,MA

2 days seminar : Strategic Compliance and Risk Management: GXP Compliance Strategies, FDA Inspections and State of Readiness and Assistance during Inspections/Post-inspection Correspondence & Meeting

By: David R Dills , Regulatory Affairs & Compliance Consultant.

An Interative Workshop Presented BY WCS & David R. Dills

Course “Strategic Compliance and Risk Management: GXP Compliance Strategies, FDA Inspections and State of Readiness and

  • 13-July-2017  To 14-July-2017 - Boston,MA

Ensuring Compliance with Marketing, Advertising and Promotional Requirements for Pharmaceuticals and Medical Devices 2017 : Two Day Seminar

By: David R Dills , Regulatory Affairs & Compliance Consultant.

An Interative Workshop Presented BY David R. Dills -Global Regulatory Affairs & Compliance Consultant 

Course “Regulatory & Compliance Strategies: Marketing, Advertising and Promotion of Pharmaceuticals and

  • 14-September-2017  To 15-September-2017 - San Diego CA

2 Day Seminar : How to write error free procedures and comply with GMP regulations

By: Ginette M. Collazo , Ph.D, President, Ginette M. Collazo, Inc..

An Interative Workshop Presented BY WCS & Ginette M. Collazo, LLC.

Course"How to write error free procedures and comply with GMP regulations" has been pre-approved by

  • 19-October-2017  To 20-October-2017 - Tampa, FL

2 Day Seminar : 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

One Day Seminar: "Effective Responses to FDA-483 forms and Warning Letters on Quality Systems"

By: J. Lawrence Stevens , Senior Regulatory and Quality Consultant at The FDA Group, LLC.

An Interative Workshop Presented BY WCS & J. Lawrence Stevens, RAC

Course “Effective Responses to FDA-483 forms and Warning Letters on Quality Systems“ has been pre-approved

  • 08-November-2017  - San Francisco, CA

1 day seminar :GMP’s in practice: quality systems, common sense compliance, and application

By: Ginette M. Collazo , Ph.D, President, Ginette M. Collazo, Inc..

An Interative Workshop Presented BY WCS & Ginette M. Collazo, LLC.

Course"GMP’s in practice: quality systems, common sense compliance, and application" has been pre-approved by RAPS

  • 07-December-2017  - Washington D.C

Live Webinar:-FDA Labeling Requirements

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

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

  • 22-February-2017 | 00.00 AM

Live webinar Supplier Management in a Compliant, Cost-Efficient Manner

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

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

  • 27-March-2017 | 00.00 AM

21 CFR Part 11 (Electronic Records/Signatures) Compliance 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 90 mins Live Webinar.

  • 22-March-2017 | 00.00 AM

Live Webinar: Best Practices in Preparation for an FDA Computer System Audit

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

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

  • 15-March-2017 | 00.00 AM

Live Webinar Implementing a Risk-Based Internal CGMP Annual Audit Program

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

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

  • 14-March-2017 | 00.00 AM

Live Webinar Proper Execution of Annual Product Reviews

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

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

  • 01-March-2017 | 00.00 AM

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 60 mins Live Webinar

  • 26-April-2017 | 00.00 AM

Live Webinar Effective FDA Regulatory Inspections

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

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

  • 20-April-2017 | 00.00 AM

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 90 mins Live Webinar

  • 19-April-2017 | 00.00 AM

Live Webinar Achieving Success and Compliance in the Supply Chain

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

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

  • 18-April-2017 | 00.00 AM

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 | 00.00 AM

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 | 00.00 AM

Live Webinar Design Inputs - Design Outputs Traceability Matrix - 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

  • 11-April-2017 | 00.00 AM

Live Webinar Implementing a Quality by Design program for product development

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

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

  • 06-April-2017 | 00.00 AM

Live Webinar Medical Device Trends for Computer Systems Regulated by FDA

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

  • 05-April-2017 | 00.00 AM

Live Webinar DHF, DMR, DHR, Technical File and Design Dossier - Key Requirements and Future Directions

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

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

  • 04-April-2017 | 00.00 AM

Live Webinar Personnel Training to Assure FDA and ISO Compliance

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

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

  • 31-May-2017 | 00.00 AM

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

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

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

  • 31-May-2017 | 00.00 AM

Live Webinar Medical Device MDR following new FDA Guidance

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

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

  • 25-May-2017 | 00.00 AM

Live Webinar Good Documentation Practices – Real World Application

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

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

  • 24-May-2017 | 00.00 AM

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

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

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

  • 18-May-2017 | 00.00 AM

FDA Guidance: Medical Device Recalls By Ex FDA investigator

By: Larry Spears ,Ex FDA investigator and President at L.Spears Consulting LLC.

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

  • 17-May-2017 | 00.00 AM

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 | 00.00 AM

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 | 00.00 AM

Live Webinar Continuous Improvement Tools for your Quality Management System

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

  • 10-May-2017 | 00.00 AM

Live Webinar Effective Batch Record Review and Product Release

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

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

  • 04-May-2017 | 00.00 AM

Live Webinars How to Conduct a Human Factors/ Usability Validation

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

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

  • 03-May-2017 | 00.00 AM

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 | 00.00 AM

Live Webinar Medical device cybersecurity following latest FDA Guidance

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

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

  • 06-June-2017 | 00.00 AM

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 | 00.00 AM

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 | 00.00 AM

Live Webinar Risk Based Environmental Monitoring

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

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

  • 15-June-2017 | 00.00 AM

Live Webinar Medical Devices - International Regulatory Compliance & Regulatory Affairs

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

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

  • 20-June-2017 | 00.00 AM

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 | 00.00 AM

Live Webinar How to properly Investigating OOS results

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

This webinar will review the regulatory requirements for investigating an OOS Investigation.

  • 28-June-2017 | 00.00 AM

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 | 00.00 AM

Live Webinar Understanding Aseptic Technique and Cleanroom Behavior

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

Aseptic technique, in sterile compounding, contributes in preventing microbiological contamination.

  • 05-July-2017 | 00.00 AM

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 | 00.00 AM

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 | 00.00 AM

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 | 00.00 AM

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 | 00.00 AM

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.

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

  • 12-July-2017 | 00.00 AM

Live Webinar Conducting a Regulatory Documentation and Training Gap Analysis 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 60 mins Live Webinar

  • 18-July-2017 | 00.00 AM

Live Webinar Management Controls Under FDA QSR and ISO 13485

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

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

  • 18-July-2017 | 00.00 AM

Live Webinar Current Concepts & Challenges in Cloud Compliance

By: Angela Bazigos ,CEO Touchstone Technologies Silicon Valley.

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

  • 11-July-2017 | 00.00 AM

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 | 00.00 AM

3-hr webinar:Design Controls for Medical Devices

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

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

  • 20-July-2017 | 00.00 AM

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

  • 12-September-2017 | 00.00 AM

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 | 00.00 AM

Live Webinar Regulatory Submissions all Part of CMC

By: JERRY DALFORS ,Principal, JD Technologies.

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

  • 19-July-2017 | 00.00 AM

Live webinar Quality Risk Management By Steven Laurenz

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

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

  • 25-July-2017 | 00.00 AM

Live Webinar Qualification of contract manufacturer organizations based on practical experience

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

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

  • 26-July-2017 | 00.00 AM

Live Webinar Implementing a Change Control Quality System Successfully

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

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

  • 27-July-2017 | 00.00 AM

Live Webinar Using Microsoft Excel to Ensure Accurate Analysis, Monitoring and Training to be within required FDA Compliance – profitability

By: JERRY DALFORS ,Principal, JD Technologies.

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

  • 02-August-2017 | 00.00 AM

Live Webinar Project Management for Computer Systems Regulated by FDA

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

This course will describe the best practices for managing such a project, including "who" should be responsible for tasks, "how" the documentation should be accomplished,

  • 12-July-2017 | 00.00 AM

Live Webinar 21 CFR 11 Compliance for Excel Spreadsheets

By: Angela Bazigos ,CEO Touchstone Technologies Silicon Valley.

In Dec. 2010, the FDA has stepped up enforcement for 21 CFR 11 compliance with spreadsheets being considered as low hanging fruit for FDA inspectional

  • 27-July-2017 | 00.00 AM

Live Webinars NAFTA:"Understanding the Rules of Origin and Certificate of Origin Requirements"

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

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

  • 22-March-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 60 mins Live Webinar.

  • 28-March-2017

Live Webinar Harmonized Tariff Schedule Classification

By: Jan Seal ,International Trade Consultant.

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

  • 25-April-2017
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