Latest Compliance Strategies for Marketing, Advertising and Promotion of Pharmaceuticals and Medical Devices

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

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

Course “Compliance Strategies for Marketing, Advertising and Promotion of Pharmaceuticals and Medical

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

Current issues in assuring data integrity in life sciences : 2 Days Seminar

By: Chinmoy Roy , BSEE, MSCS US FDA Expert Data integrity & CSV.

This interactive two-day workshop planned by WCS provides attendees the opportunity to interact with a Data Integrity Subject Matter Expert.  Filled with numerous case studies

  • 04-October-2017  To 05-October-2017 - Boston,MA
  • 14-November-2017  To 15-November-2017 - San Diego CA

2017 workshop 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

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

2017 workshop 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 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

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 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 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 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:-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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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 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

3-hr webinar:Design Controls for Medical Devices

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

Design Controls are an integrated set of management practices that are customer focused and ensure quality and consistency.

  • 31-July-2017

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

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

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

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

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

Live Webinar Scrutinizing Test Method Validation (TMV) to Verify the Performance of a Medical Device

By: José Mora ,Principal Consultant.

Test method validation is an often-confusing requirement for medical devices. A fundamental issue is the role-reversal between the test method and the product or process

  • 02-August-2017

The FDA Inspection: From SOP to 483

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

This is a detailed course designed to provide medical device/pharmaceutical professionals with the information they require to prepare for and manage FDA inspections

  • 10-August-2017

Live Webinar 2017-DMFs in eCTD format

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

You will gain an understanding of contact points with the FDA throughout the lifecycle of the DMF

  • 15-August-2017

Live Webinar Organizational Change Management Best Practices for Computer System Validation in Industries Regulated by FDA

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

Organizational change management is a key aspect of computer system activities involving the FDA’s guidelines on the system development life cycle (SDLC).

  • 16-August-2017

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

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

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

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

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

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

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

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

Live Webinar Regulatory Submissions all Part of 510K

By: JERRY DALFORS ,Principal, JD Technologies.

FDA BRIEFING Documents

  • 06-September-2017

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

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

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

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
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