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.

Lean Documents and Lean Configuration

  • 07-June-2018

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 90 mins Live Webinar

  • 06-August-2018

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

  • 26-March-2018

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

  • 19-October-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

  • 03-October-2017

Live Webinar Best Practices for Investigating Deviations and CAPA to avoid 483 observations

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,

  • 04-April-2018

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

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

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

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

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

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

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

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

Live Webinar How to conduct Annual Product Reviews to achieve GMP Compliance

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

Learn how to write APRs

  • 15-March-2018

Live Webinar Understanding and Implementing a Quality by Design Program

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

The benefits of applying the QbD principles in the pharmaceutical industry have been well advertised.

  • 02-May-2018

Live Webinar Understanding and Implementing a Technology Transfer Process

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

Identify New Product transfer process

  • 27-June-2018

Live Webinar Designing An Effective Cleaning Validation For Reusable Medical Devices In Today's Regulatory Environment

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

FDA expectations regarding reusable medical device design considerations

  • 28-February-2018

Live Webinar Disaster Recovery and Business Continuity Planning for Computer Systems Regulated by FDA

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

Gain an understanding of disaster recovery and business continuity planning

  • 26-February-2018

Live Webinar Privacy And Security: Learn From Best Practices For HIPAA Compliance

By: Angela Bazigos ,CEO Touchstone Technologies Silicon Valley.

HIPAA Compliance Best Practices

  • 12-March-2018

Live Webinar FDA's Two New Guidance Documents on Software and Device Changes and the 510(k)

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

Control of medical device changes and a current 510(k) are big issues in recent FDA studies

  • 27-March-2018

Live webinar Tougher Supplier Controls – Avoid Unwanted Changes

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

The Globalization of the Supply Chain and What That Means

  • 18-April-2018

Live Webinar Product Complaints: Complaint Handling From Intake To Closure

By: David R. Dills ,Global Regulatory Affairs & Compliance Consultant and President, NovaQual.

If the complaint triggers a Medical Device Report (MDR), ensure that the complaint file is clearly identified or maintained separately from other complaint files

  • 09-March-2018

Live Webinar Medical Devices: Developing Effective Post Market Surveillance and Complaint Handling Systems

By: David R. Dills ,Global Regulatory Affairs & Compliance Consultant and President, NovaQual.

When does a complaint become a reportable event?

  • 01-April-2018

Live Webinar Successful FDA Meeting Preparation and Conduct

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

Rehearsal, post-meeting follow-up, and documenting nonformal FDA interactions will also be discussed in detail.

  • 25-April-2018

3 hrs Webinar Creating and Maintaining an Effective and Efficient Technical Training Program

By: DR. Ginette M. Collazo ,Owner - Industrial/Organizational Psychologist.

GMP regulations on the training topic.

  • 04-April-2018

Live Webinar Regulatory Compliance in the Pharmaceutical Supply Chain

By: Angela Bazigos ,CEO Touchstone Technologies Silicon Valley.

FDA's challenge is the restructuring of a company's supply chain

  • 20-March-2018

Live Webinar Design History File (DHF), the Device Master Record (DMR) and the Device History Record (DHR) - Principles of Lean Documents and Lean Configuration

By: José Mora ,Principal Consultant.

webinar presents a fresh new approach based upon solid principles and proven practices – as well as an alternative, applies the Theory of Lean Documents

  • 05-April-2018

Live Webinar Chipping away at constraints – Practical tips to improve your manufacturing operations

By: José Mora ,Principal Consultant.

Some of us feel that we have to hire a guru in order to apply the Theory of Constraints. Here are some practical things all

  • 25-May-2018

Live Webinar EO Sterilization Validation / Revalidation per ISO 11135

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

A brief discussion of the lethal rate BI / bioburden approach, and a more detailed discussion of the more commonly used Overkill approach descriptions,

  • 26-June-2018

Live Webinar Disaster Recovery and Business Continuity Planning for Computer Systems Regulated by FDA

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

Disaster Recovery and Business Continuity

  • 08-August-2018

Live Webinar Building effective project teams

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

Building the project team

  • 16-July-2018

2018 Guidelines on How to Best Use Regulatory Pathways: ANDA and 505 (b)(2)

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

Understand FDA’s regulatory pathway 505(b)2

  • 21-June-2018
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