2 Days Workshop: Computer systems Validation (CSV) for Excel Spreadsheets

By: Angela Bazigos , CEO Touchstone Technologies Silicon Valley.

An Interative Workshop Presented BY WCS & Angela Bazigos CEO, Touchstone Technologies Silicon Valley (40+ years of exp)

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

2 Days Workshop:FDA Penalties for Regulatory Non-Compliance in the Pharmaceuticals Industry - 2017 in Review

By: Brian G. Nadel, RAC , President of Brian G. Nadel, GMP Consulting, LLC..

The FDA is increasing its enforcement actions both for domestic and foreign inspections

  • 30-January-2018  To 31-January-2018 - San Diego CA

2 Day Workshop: Preparing For The New EU Medical Device Regulations (MDR)

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

The deadline for compliance to the European Medical Device Regulation (EU-MDR) is May 2020. Manufacturers are strongly advised to start considering the impact on their

  • 21-February-2018  To 22-February-2018 - Burlingame, CA

2 Day Workshop: FDA Inspections: What Regulators Expect and How to Prepare

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

  • 14-March-2018  To 15-March-2018 - San Diego CA

2 Day Workshop: Human Error: Why Human Error is the biggest downtime problem in the manufacturing sector and how to investigate, control, reduce, and prevent to improve results.

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

This interactive workshop teaches you how to reduce your manufacturing error rates by 50%. 

  • 15-March-2018  To 16-March-2018 - New Brunswick

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

  • 22-March-2018  - Washington D.C

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

  • 05-April-2018  To 06-April-2018 - San Diego CA

2 Day Workshop Product Registration and Navigating the Approval Process with Regulatory Authorities in Asia Pacific, Europe, Middle East and The Americas

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

Need assistance with medical device registration and medical device approval

  • 25-April-2018  To 26-April-2018 - Boston,MA

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, 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

  • 17-October-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.

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.

  • 22-September-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.

  • 10-January-2018 | 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

  • 15-February-2018 | 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.

how to establish a risk-based Environmental Monitoring Program

  • 20-February-2018 | 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 investigate OOS Results

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

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

  • 13-March-2018 | 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.

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 | 00.00 AM

Live Webinar Management Controls Under FDA QSR and ISO 13485

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

  • 02-October-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..

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

  • 31-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

  • 29-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.

  • 26-September-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.

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

  • 27-September-2017 | 00.00 AM

Live Webinar Implementing a Change Control Quality System Successfully

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

  • 05-October-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,

  • 29-November-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 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 | 00.00 AM

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 | 00.00 AM

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 | 00.00 AM

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 | 00.00 AM

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

  • 03-October-2017 | 00.00 AM

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

  • 26-October-2017 | 00.00 AM

Live webinar: U.S. Export Documentation and Procedures

By: Jan Seal ,International Trade Consultant.

Keep current with the changes that have taken place with the export regulations including changes in 2017

  • 22-August-2017 | 00.00 AM

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 | 00.00 AM

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 | 00.00 AM

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 | 00.00 AM

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,

  • 21-March-2018 | 00.00 AM

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 | 00.00 AM

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 | 00.00 AM

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 | 00.00 AM

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 | 00.00 AM

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 | 00.00 AM

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 | 00.00 AM

Live Webinar Regulatory Submissions all Part of 510K

By: JERRY DALFORS ,Principal, JD Technologies.

FDA BRIEFING Documents

  • 06-September-2017 | 00.00 AM

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

  • 05-October-2017 | 00.00 AM

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 | 00.00 AM

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 | 00.00 AM

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 | 00.00 AM

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

  • 09-October-2017 | 00.00 AM

3 Hrs Webinar on 505(b)(2) NDAs By Peggy J. Berry, (Ex FDA)

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

What is a 505(b)(2)

  • 14-November-2017 | 00.00 AM

Live Webinar Review of global strategic drug development opportunities

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

Learn how to plan, control and manage a full global development

  • 12-October-2017 | 00.00 AM

Live Webinar ICH Q11- API Manufacturing

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

Q11 guidance and learn skills for practical implementation of those requirements.

  • 01-November-2017 | 00.00 AM

Live Webinar Pediatric Safety Plan (PSP) in the US

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

Learn how to prepare a PSP

  • 12-October-2017 | 00.00 AM

Live Webinar Post Marketing and Regulatory Complinace

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

The post-marketing obligations encompass more functional areas of the company

  • 06-December-2017 | 00.00 AM

Live Webinar :Device Warning Letters - Review

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

Learn the FDA process for issuance of warning letters

  • 03-October-2017 | 00.00 AM

Live Webinar Quality Assurance During the Clinical Trial

By: Richard Chamberlain ,Owner at Extended Clinical Services, LLC.

This course will give you an introduction to where to do quality assurance and how to do it.

  • 12-October-2017 | 00.00 AM

Critical Factors when Developing an Employee Handbook That Protects Your Company!

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

Did you know that Employee Handbooks can be a risk or a benefit for Employers? For years an Employee Handbook has been one of the

  • 19-October-2017 | 00.00 AM

Live Webinar Achieving Sustainability Results with ISO 26000

By: Kelly Eisenhardt ,Co-Founder and Managing Director of BlueCircle Advisors.

Social responsibility is a high priority for corporate leaders focused on increasing brand awareness along with revenues. It has become a critical success factor for

  • 18-October-2017 | 00.00 AM

Live Webinar Managing Corporate Risks with ISO 31000

By: Kelly Eisenhardt ,Co-Founder and Managing Director of BlueCircle Advisors.

An in depth look into the key components of the ISO 31000 guideline and best practices to implement and support a corporate risk management strategy

  • 17-January-2018 | 00.00 AM

Live Webinar Protecting Your Business with the 5 Critical Conflict Minerals and Anti-Trafficking Regulations

By: Kelly Eisenhardt ,Co-Founder and Managing Director of BlueCircle Advisors.

An in depth look into regulations enacted to manage sourcing of materials from war torn countries and the prevention of supply chain human trafficking and

  • 12-December-2017 | 00.00 AM

Live Webinar Supply Chain and Product Compliance Using RoHS, REACH, and Conflict Minerals

By: Kelly Eisenhardt ,Co-Founder and Managing Director of BlueCircle Advisors.

This training program will offer an in-depth look at three important product regulations focused on materials compliance and ethical sourcing, along with the tools and

  • 08-November-2017 | 00.00 AM

Live Webinar Batch Production Record and Device History Record Review and Quality Assessment to ensure compliance with DMF and DMR specifications

By: JERRY DALFORS ,Principal, JD Technologies.

BPRs, DHRs and laboratory control records for critical process steps are to be reviewed and approved by the quality unit(s) before a finished product batch

  • 05-October-2017 | 00.00 AM

Live Webinar FDA Focus:Purchasing / Supplier Controls for Medical Devices

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

Purchasing Controls have received significant scrutiny from the FDA in recent years due to an increase in adverse events and recalls.

  • 18-October-2017 | 00.00 AM

Live Webinar Mathematics of Terminal Sterilization - Probability of Survival Approach -vs- Overkill Approach

By: JERRY DALFORS ,Principal, JD Technologies.

Different microorganisms in different environments during sterilization have different resistance to the destructive principles that causes the organism or spore to die (lethality) Some extreme

  • 01-November-2017 | 00.00 AM

Live Webinar Process Validation - Statistical Process Control

By: JERRY DALFORS ,Principal, JD Technologies.

To gain a current comprehension of the new PV Guidelines

  • 05-December-2017 | 00.00 AM

Live Webinar : Master Verification and Validation Planning and Implementation

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

Verification and validation requirements have always been part of the US FDA’s GMPs

  • 06-December-2017 | 00.00 AM

Live Webinar Validation Concepts for Medical Devices By Susanne Manz

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

Validation is an important element of the Quality System Regulations and ISO13485.

  • 22-November-2017 | 00.00 AM

Live Webinar Design Control, Device Risk Management, and Usability Engineering, Under US CGMPs 21 CFR 820 and ISO 13485

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

The FDA expects companies to perform meaningful, results driven Design Control activities as defined in the CFR, for both new and changed devices. ISO 13485:2016

  • 15-November-2017 | 00.00 AM

Live Webinar Writing Effective Standard Operating Procedures and Work Instructions

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

Developing effective regulatory procedures requires an understanding of how documentation should be structured and organized as well as how they should be crafted.

  • 15-December-2017 | 00.00 AM

Live Webinar on Cybersecurity By Angela Bazigos

By: Angela Bazigos ,CEO Touchstone Technologies Silicon Valley.

When hackers breach cybersecurity defenses, the risks to enterprises are enormous.

  • 17-November-2017 | 00.00 AM

3 hr Live Webinar Reduce Human Error on the Drug and Device Manufacturing Processes

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

Human Error as the Root Cause

  • 29-November-2017 | 00.00 AM

Live Webinar How to Write Error Free and FDA Compliant Procedures

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

This course offers practical approaches and tools to address human performance issues in GMP related environments

  • 28-February-2018 | 00.00 AM

Live Webinar How to write SOP's that Avoid Human Error

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

SOP writing outline

  • 24-January-2018 | 00.00 AM

Live Webinar Surviving an FDA Inspection: Understand the Do's and Don'ts and the Ground Rules

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

FDA inspections

  • 14-December-2017 | 00.00 AM

Live Webinar How to Select & Manage Vendors in a Regulated Environment (incl. ICH E6)

By: Angela Bazigos ,CEO Touchstone Technologies Silicon Valley.

Software is widely used in our industry and selection of new software or upgrade of existing software is one of the activities that crop up

  • 23-January-2018 | 00.00 AM

Live Webinar Medical Devices User Fee Act III Implementation (MDUFA III)

By: Angela Bazigos ,CEO Touchstone Technologies Silicon Valley.

MDUFA III

  • 25-January-2018 | 00.00 AM

Live webinar Qualification of contract manufacture organizations (cmo)-a risk based approach

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

CMO management principles

  • 25-January-2018 | 00.00 AM

Live Webinar How to Conduct a Human Factors/ Usability Validation

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

Human Factors/ Usability Validation

  • 01-February-2018 | 00.00 AM

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

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

The FDA requirements for cybersecurity in the app design will be explained

  • 14-February-2018 | 00.00 AM

Live Webinar European Data Protection Regulation – 2018 Implementation

By: Angela Bazigos ,CEO Touchstone Technologies Silicon Valley.

European Data Protection Regulation

  • 10-January-2018 | 00.00 AM

6 hrs FDA Boot Camp Off Label Promotion for Drugs & Medical Devices

By: Angela Bazigos ,CEO Touchstone Technologies Silicon Valley.

FDA and industry have struggled for the past 10 years, with the question of how FDA can reconcile its mission to protect public health by

  • 06-March-2018 | 00.00 AM

6-hr Webinar-Deciding When to Submit a 510(k) for a Change to an Existing Device – FDA’s Final Guidance

By: Angela Bazigos ,CEO Touchstone Technologies Silicon Valley.

A premarket notification (510(k))

  • 16-February-2018 | 00.00 AM

Live Webinar Medical Device Complaints and Corrective and Preventative Action (CAPA)

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

This CAPA webinar for Medical device will guide you how CAPA and complaint handling should interact in Medical Device, and Identifying the root cause of

  • 14-March-2018 | 00.00 AM

Live Webinar Technical Training in the Life Sciences

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

Training and Development has its own body of knowledge and a wide range of techniques and approaches designed to meet unique and complex training challenges

  • 12-January-2018 | 00.00 AM

Live webinar Medical Device Industry Trends for Computer Systems Regulated by FDA

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

The Webinar will focus on the importance of managing FDA oversight of computer system validation

  • 21-March-2018 | 00.00 AM

Live Webinar 21 CFR Part 11 (Electronic Records/Electronic Signatures) Compliance for Computer Systems Regulated by FDA

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

FDA's 21 CFR Part 11 guidance

  • 19-January-2018 | 00.00 AM

Live Webinar Customs and Trade Partnership Against Terrorism (C-TPAT) Compliance

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

C-TPAT program overview including “Tiered” strategy

  • 07-February-2018 | 00.00 AM

Live Webinar Current FDA Laws and Regulations on Radiation-Emitting Products and Radiation-Emitting Electronic Products

By: Dr. David Lim Ph.D., RAC, ASQ-CQA ,President and Principal of Regulatory Doctor.

Current FDA Radiation Control Laws

  • 24-January-2018 | 00.00 AM

Live Webinar Capturing Justifications in Change Control, Risk Assessment, Validations, and Investigations

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

undertake the planned investigation, change control, risk assessment or validation

  • 04-April-2018 | 00.00 AM

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

Live Webinar Strategies for Avoiding Employment Discrimination Claims

By: Janette Levey Frisch ,Employment/HR Attorney| Founder, Law Office of Janette Levey Frisch|The Employer's Legal Wellness Professiona.

This webinar will familiarize you with and sensitize you to the key pitfalls to be aware of and avoid and provide you with some practical

  • 10-October-2017

3 ½ Hours Webinar : How to Survive an FDA Food Facility Inspection ?

By: Angela Bazigos ,CEO Touchstone Technologies Silicon Valley.

About 48 million people (1 in 6 Americans) get sick, 128,000 are hospitalized, and 3,000 die each year from foodborne diseases, according to recent data

  • 25-January-2018

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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