Jerry Dalfors speaker of compliance global

Speaker: Jerry Dalfors
Duration: 60 Minutes
Product ID: 700006

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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...

Les Schnoll speaker of compliance global

Speaker: Les Schnoll
Duration: 90 Minutes
Product ID: 700018

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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...

Jerry Dalfors speaker of compliance global

Speaker: Jerry Dalfors
Duration: 90 Minutes
Product ID: 700048

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Process Validation in Statistical Process Control

The ultimate goal of FDA Process Validation is to ensure continual assurance that the process once initially validated (PQ now PPQ) and submitted for FDA/EU approval remains in a state of control b 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: 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...

Larry Spears  speaker of compliance global

Speaker: Larry Spears
Duration: 60 Minutes
Product ID: 700084

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Registration & Listing, FDA Inspection Strategies and Compliance Initiatives - Medical Device.

Have you ever wondered about the FDA strategies for scheduling inspections and pursuing compliance plans?  This seminar will provide clarity around those issues from a compliance expert with o more...

Richard Chamberlain speaker of compliance global

Speaker: Richard Chamberlain
Duration: 90 Minutes
Product ID: 700065

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Implementing 21 CFR Part 11 - What is Computer Systems Validation and how to Implement it.

This system validation webinar training by the expert speaker will cover the Computer Systems Validation Regulations and then cover how a company complies with those regulations when they implement 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...

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: 700221

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Establishing a Reduced Testing Process for Incoming Materials

The first step in reduced testing is to qualify the supplier using the supplier qualification process. This webinar will review the supplier qualification process. The sequential steps for more...

Jd Marhevko speaker of compliance global

Speaker: Jd Marhevko
Duration: 60 Minutes
Product ID: 700326

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Attribute Agreement Analysis (AAA). This is for the calibration of humans. Measurement System Analysis (MSA) for attributes. How to conduct a basic AAA and interpret the results

A review of basic AAA analysis. Will cover the 3 basic types of agreements: Agreement with oneself, Agreement to a peer, Agreement to the standard. Both the "Statistical AAA" and the Kappa training more...

Howard  T Cooper speaker of compliance global

Speaker: Howard T Cooper
Duration: 90 Minutes
Product ID: 700397

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Establishing a Reduced Testing Process for Incoming Materials

The first step in reduced testing is to qualify the supplier using the supplier qualification process. This webinar will review the supplier qualification process. The sequential steps for more...

Jd Marhevko speaker of compliance global

Speaker: Jd Marhevko
Duration: 60 Minutes
Product ID: 700356

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Dynamic Control Plan (DCP). The blend of the Process Failure Modes Effects Analysis (PFMEA) and Control Plan (CP). How to develop, interpret and gain system benefits from a DCP

Come celebrate the union of the PFMEA training and the CP! See how the Dynamic Control Plan (DCP) combines both tools into ONE enabling the savings of hundreds of hours of Engineering time, reducin more...

Jd Marhevko speaker of compliance global

Speaker: Jd Marhevko
Duration: 60 Minutes
Product ID: 700461

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Calibrating the Human Gage: Attribute Agreement Analysis (AAA)

Humans CAN BE calibrated. Control plans call out for “MSA” analysis on key processes. Inevitably, these mainly focus on features measured by variables gaging systems. However, MSA analy more...

Jd Marhevko speaker of compliance global

Speaker: Jd Marhevko
Duration: 60 Minutes
Product ID: 700511

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The Marriage of the PFMEA and Control Plan…A Dynamic Control Plan (DCP)

The Dynamic Control Plan (DCP) is a blend of the Process Failure Modes Analysis (PFMEA) and Control Plan (CP) into one document! It entirely eliminates the need for a stand-alone Control Plan. By e more...

Jd Marhevko speaker of compliance global

Speaker: Jd Marhevko
Duration: 60 Minutes
Product ID: 700417

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Paynter Charts. How to develop and use paynter charts for predictive warranty analysis

Attendees will walk away with a Paynter chart model that they can apply to their own organizations while learning how to mitigate business cost exposure.  What’s a Paynter more...

William A. Levinson speaker of compliance global

Speaker: William A. Levinson
Duration: 60 Minutes
Product ID: 700699

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Introduction to Design of Experiments

Design of Experiments is a vital tool for process improvement and root cause analysis. It allows experimenters to determine beyond a quantifiable reasonable doubt that an experiment improves the pr more...