José Mora speaker of compliance global

05
Wed
Apr, 2017

Speaker: José Mora
Duration: 60 Minutes
Product ID: 700660

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

The Theory of Lean Documents is the product of applying lean principles to the creation, design, process, and management of controlled documents typically found in regulated industries.   Justmore...

José Mora speaker of compliance global

18
Tue
Apr, 2017

Speaker: José Mora
Duration: 90 Minutes
Product ID: 700701

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An Advanced Course on Lean Documents, Lean Configuration and Document Control

In this Lean Documents, Lean Configuration, and Document Control training learn the different types of lean documents and the usage of lean document principles; types of controlled documents; exampmore...

Susanne Manz speaker of compliance global

20
Thu
Apr, 2017

Speaker: Susanne Manz
Duration: 90 Minutes
Product ID: 700653

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Essentials of Complaint Handling and Medical Device Reporting

Complaint management and Medical Device Reporting (MDR) are critical quality systems for you to meet the needs of your 3 key stakeholders – the customer, the regulators, and your business. &nmore...

Keith Gibbs speaker of compliance global

26
Wed
Apr, 2017

Speaker: Keith Gibbs
Duration: 90 Minutes
Product ID: 700705

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Lessons Learned in the Design, Installation, Start-Up and Qualification of Clean Compressed Air Systems for cGMP Manufacturing

In the pharmaceutical industry, compressed air is used for a number of production and packaging applications, including blowing off and drying bottles prior to filling, conveying pills, providing amore...

David R Dills speaker of compliance global

Speaker: David R Dills
Duration: 60 Minutes
Product ID: 700235

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Importing and Exporting Medical Devices: A Primer on Regulatory Strategy and Requirements

Any Medical Device that is legally in the U.S. may be exported anywhere in the world without prior FDA notification or approval. The export provisions under section 802 of the FD&C Act only app more...

John E.  Lincoln speaker of compliance global

Speaker: John E. Lincoln
Duration: 90 Minutes
Product ID: 700015

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The Best Way to Develop or Improve a Master Validation Plan

How to develop or improve upon a Master Validation Plan / Validation Master Plan or System that meets U.S. FDA CGMP, ICH Q-series, and ISO 13485 expectations and requirements.FDA Warnin more...

José Mora speaker of compliance global

Speaker: José Mora
Duration: 90 Minutes
Product ID: 700027

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21 CFR Part 820 - Applying Principles of Lean Documents and Lean Configuration

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 in the form of records. more...

José Mora speaker of compliance global

Speaker: José Mora
Duration: 90 Minutes
Product ID: 700041

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Traceability Matrix - Principles of Lean Documents and Lean Configuration

Design control process involves the translation of user requirements (aka Voice of the Customer) into specific technical requirements as design inputs.  These design inputs then form the basis more...

Dr. David Lim speaker of compliance global

Speaker: Dr. David Lim
Duration: 60 Minutes
Product ID: 700078

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Best Practices for FDA-Compliant Cybersecurity Management for Premarket Submissions of Medical Devices.

This webinar is intended to help you get familiar with the FDA-compliant management of medical device cybersecurity for regulatory purposes.This webinar is further intended to increase more...

Dev Raheja speaker of compliance global

Speaker: Dev Raheja
Duration: 60 Minutes
Product ID: 700054

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Process Validation with a Product Lifecycle Concept to Meet FDA Requirements

Process validation training activities with a product lifecycle management concept and the FDA risk management framework is critical for the medical device industry, because most of the device fail more...

José Mora speaker of compliance global

Speaker: José Mora
Duration: 90 Minutes
Product ID: 700059

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Creation of Unique DHFs, DMRs, and DHRs using the Principles of Lean

The Theory of Document Management system is the product of applying lean principles to the creation, design, process, and management of controlled documents typically found in regulated industries. more...

José Mora speaker of compliance global

Speaker: José Mora
Duration: 75 Minutes
Product ID: 700082

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Corrective and Preventive Action utilizing the theory of Lean Documents.

The Theory of Lean Documents is the product of applying lean principles to the creation, design, process, and management of controlled documents typically found in regulated industries. Just as lea more...

José Mora speaker of compliance global

Speaker: José Mora
Duration: 60 Minutes
Product ID: 700068

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A Fresh Approach to Controlled Document System using Principles of Lean Documents and Lean Configuration.

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

John E.  Lincoln speaker of compliance global

Speaker: John E. Lincoln
Duration: 90 Minutes
Product ID: 700045

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Software Verification and Validation in Medical Industry

The verification and validation of medical industry software is coming under increased scrutiny by the U.S. FDA.  This webinar will address the use of the FDA, GAMP, 21 CFR 11, and other appli more...

Robert L. Kunka, Ph. D. speaker of compliance global

Speaker: Robert L. Kunka, Ph. D.
Duration: 60 Minutes
Product ID: 700124

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Paediatric Drug Development - Adult Data and Relevant FDA Laws.

Up until a few years ago FDA required pharmaceutical companies to duplicate the same studies that were required in adults in children. This requirement often prevented development in children becau more...

Larry Spears  speaker of compliance global

Speaker: Larry Spears
Duration: 60 Minutes
Product ID: 700088

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Corrective and Preventive Action (CAPA) and Complaint Handling in Medical Device.

Have you ever wondered about how FDA approaches CAPA (corrective and preventive actions) and complaint issues during inspections? What about how they manage those activities and what they are looki more...

Larry Spears  speaker of compliance global

Speaker: Larry Spears
Duration: 90 Minutes
Product ID: 700102

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Medical Device Export Approvals and Certificates in compliance with FDA regulations

Firms exporting products from the U.S. are often asked by foreign customers or foreign governments to supply proof of the products’ status as regulated by the FDA. An export certificate is a more...

Jerry Dalfors speaker of compliance global

Speaker: Jerry Dalfors
Duration: 60 Minutes
Product ID: 700176

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CAPA Training and Causes of Warning Letters due to Lack of Comprehension

CAPA (Corrective and Preventative Actions) did not originate in the Pharmaceutical and Medical Device industry or the Automobile Industry as most folks post on the Internet.  The program to ma more...

Marie Dorat speaker of compliance global

Speaker: Marie Dorat
Duration: 90 Minutes
Product ID: 700249

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Unique Device Identifier (UDI) Implementation

This webinar on Unique Device Identifier (UDI) requirements will discuss the new rules implemented by FDA. Attendees will get an overview of the new requirement and how to implement. more...

John E.  Lincoln speaker of compliance global

Speaker: John E. Lincoln
Duration: 90 Minutes
Product ID: 700098

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The FDAs DHF, DMR and DHR Design Dossier for Documentation

The FDA's Design History Files, Device Master Records, Device History Record, and the EU's MDD TF/DD -- Documentation to meet their different purposes and device classifications.  This webinar more...

Les Schnoll speaker of compliance global

Speaker: Les Schnoll
Duration: 90 Minutes
Product ID: 700039

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The Values and Benefits of Medical Device Reporting Compliance

Since the mid 1980s, the FDA has expressed concerns about their need to be informed of adverse events that may have been caused by or contributed to legally marketed medical devices.  As such, more...

Howard  T Cooper speaker of compliance global

Speaker: Howard T Cooper
Duration: 90 Minutes
Product ID: 700196

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A Comparison of the Pharmaceutical and Medical Device Good Manufacturing Practices - A Study of Similarities and Differences.

This webinar will explore differences and similarities between these GMPs as well as show how they relate to other quality systems, regional regulations, and guidance documents. Examples include IC more...

Edwin Waldbusser speaker of compliance global

Speaker: Edwin Waldbusser
Duration: 60 Minutes
Product ID: 700286

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21 CFR Part 11 Compliance

This Webinar will explain what 21 CFR Part 11 training is, why it is important to c companies and how conformance to Part 11 differs from just having good IT security. Procedures for controlling el more...

John E.  Lincoln speaker of compliance global

Speaker: John E. Lincoln
Duration: 90 Minutes
Product ID: 700348

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21 CFR Part 11: Understanding the ERES Regulation for Compliance Success

The verification and validation of medical industry software used in CGMP compliance records and defined under 21 CFR 11, “Electronic Records / Electronic Signatures” is coming under in more...

Tony Imm speaker of compliance global

Speaker: Tony Imm
Duration: 60 Minutes
Product ID: 700328

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Best Practices for Compliance with FDA 21CFR1040

All manufacturers, system integrators and importers of lasers or laser containing products must comply with FDA regulation training 21CFR1040 with very few exceptions. This is accomplished by a sel more...

Susanne Manz speaker of compliance global

Speaker: Susanne Manz
Duration: 60 Minutes
Product ID: 700336

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Using Metrics to Monitor and Improve your Quality Management System

Medical Device companies need effective metrics and dashboards to ensure they are proactively and consistently meeting the regulatory compliance training needs for all their stakeholders: C more...

Edwin Waldbusser speaker of compliance global

Speaker: Edwin Waldbusser
Duration: 60 Minutes
Product ID: 700437

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Human Factors and Usability Studies

Human Factors Usability is the analysis of how people interact with medical devices and medical device risk analysis. The various types and methods of human factors analysis will be explained. This more...

Howard  T Cooper speaker of compliance global

Speaker: Howard T Cooper
Duration: 90 Minutes
Product ID: 700398

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A Comparison of the Pharmaceutical and Medical Device Good Manufacturing Practices - A Study of Similarities and Differences.

This webinar will explore differences and similarities between these GMPs as well as show how they relate to other quality systems, regional regulations, and guidance documents. Examples include IC more...

Norma Skolnik speaker of compliance global

Speaker: Norma Skolnik
Duration: 60 Minutes
Product ID: 700374

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U.S. Adverse Event Reporting Regulations for Drugs, Dietary Supplements & Cosmetics

In order to market dietary supplements and OTC drugs list in the U.S., reporting serious adverse events is required. more...

Susanne Manz speaker of compliance global

Speaker: Susanne Manz
Duration: 90 Minutes
Product ID: 700426

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Production and Process Controls for Medical Devices

Production and Process Controls (P&PC) are one of the key capabilities necessary for medical device companies to consistently and effectively produce products. more...

Carolyn Troiano speaker of compliance global

Speaker: Carolyn Troiano
Duration: 90 Minutes
Product ID: 700514

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Trial Master File (TMF): FDA Expectations from Sponsors and Sites.

Companies engaged in the conduct of human clinical trials must adhere to specific government regulatory requirements. Certain documents, content and images related to a clinical trial must be store more...

Karl R.  Leinsing speaker of compliance global

Speaker: Karl R. Leinsing
Duration: 60 Minutes
Product ID: 700510

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FDA Chapter 21 CFR Subpart C Section 820.30 – Design Control Requirements

This webinar will discuss why certain steps are so important in the design process and that many steps are not just wasted time and paperwork. The process is a methodical approach that can be used more...

Susanne Manz speaker of compliance global

Speaker: Susanne Manz
Duration: 90 Minutes
Product ID: 700493

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Secrets to Writing Effective SOPs for Medical Device QMS

Standard Operating Procedures (SOPs) are a critical ingredient in an effective and efficient Quality Management System. SOPs are typically one of the first things an investigator asks for in an ins more...

Meena Chettiar speaker of compliance global

Speaker: Meena Chettiar
Duration: 60 Minutes
Product ID: 700574

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New ISO 13485: Proposed Changes and What They Mean to the Medical Device Industry

You will gain a thorough insight into the quality system requirements of the all new International ISO 13485:2016 Standard requirements for Medical Device single audit program.  This e more...

Lena Cordie speaker of compliance global

Speaker: Lena Cordie
Duration: 60 Minutes
Product ID: 700608

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Update on Global UDI Initiatives for Medical Devices

This webinar will provide updates on the progress of unique device identification regulations around the world, including the status of the FDA’s implementation, requirements for UDI in the n more...

Edwin Waldbusser speaker of compliance global

Speaker: Edwin Waldbusser
Duration: 60 Minutes
Product ID: 700649

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How to conduct a Human Factors and Usability validation following ISO62366 and the new FDA Guidance

This webinar will explain the procedure described in ISO62366 and the 2016 FDA Guidance for a compliant human factors/ usability validation. HF/U validation is very different from device validation more...