Scrutinizing Test Method Validation (TMV) to Verify the Performance of a Medical Device
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 it is designed to detect.
Speaker: Jose Mora | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Managing The Audit Function In A Global Company
This presentation focuses on the role, skills, organizational opportunities, and the benefits of an independent audit group to advise senior management on the true causes of complex situations. Although the typical setting would be in larger multi-national companies, this role can be sized to meet the needs of all companies, especially when the situations will cross national, divisional, and organizational boundaries.
Speaker: Jose Mora | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Scrutinizing Test Method Validation (TMV) to Verify the Performance of a Medical Device
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 it is designed to detect. For example, while a defect-free process is desirable, a test method must be reliable both in detecting defects and in not rejecting acceptable samples
Speaker: Jose Mora | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Scrutinizing Test Method Validation (TMV) to Verify the Performance of a Medical Device
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 it is designed to detect. For example, while a defect-free process is desirable, a test method must be reliable both in detecting defects and in not rejecting acceptable samples
Speaker: Jose Mora | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Controlled Document System for a Life Sciences Manufacturing Plant - 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.
Speaker: Jose Mora | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Scrutinizing Test Method Validation (TMV) to Verify the Performance of a Medical Device
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 it is designed to detect. For example, while a defect-free process is desirable, a test method must be reliable both in detecting defects and in not rejecting acceptable samples
Speaker: Jose Mora | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
21 CFR Part 820 - Quality System Regulation - 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
Speaker: Jose Mora | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Effective Design of Experiments (DOE) Strategies
This DOE (Design of experiments) training focuses on DOE strategies. It is not focused on statistical methods, analysis of variance, and other techniques, but rather the overall approach for successful DOEs.
Speaker: Jose Mora | View Anytime | Price: $190.00 | View Details
Design History File (DHF), the Device Master Record (DMR) and the Device History Record (DHR) - Principles on Lean Documents and Lean Configuration
Design History Files (DHF), Device Master Records (DMR), and Device History Records (DHR) are key building blocks used in the design, development, manufacturing, and cGMP compliance for the Medical Device Industry. Too often, these are cluttered, confusing, and cause many errors due to the way they are created, organized, and managed.
Speaker: Jose Mora | View Anytime | Price: $190.00 | View Details
Design History File (DHF), the Device Master Record (DMR) and the Device History Record (DHR) - Principles on Lean Documents and Lean Configuration
Design History Files (DHF), Device Master Records (DMR), and Device History Records (DHR) are key building blocks used in the design, development, manufacturing, and cGMP compliance for the Medical Device Industry. Too often, these are cluttered, confusing, and cause many errors due to the way they are created, organized, and managed.
Speaker: Jose Mora | View Anytime | Price: $190.00 | View Details
Design History File (DHF), the Device Master Record (DMR) and the Device History Record (DHR) - Principles on Lean Documents and Lean Configuration
Design History Files (DHF), Device Master Records (DMR), and Device History Records (DHR) are key building blocks used in the design, development, manufacturing, and cGMP compliance for the Medical Device Industry. Too often, these are cluttered, confusing, and cause many errors due to the way they are created, organized, and managed.
Speaker: Jose Mora | View Anytime | Price: $190.00 | View Details
Risk Management Utilizing Lean Documents and Lean Configuration
If you are constantly struggling to create, manage, and maintain all of the information found in the various Risk Management documents and files, all of which are often redundant, repetitive, and clustered together in an awkward manner, this webinar is something that will give you a different perspective and a very different approach that you can use.
Speaker: Jose Mora | View Anytime | Price: $190.00 | View Details
Design History File (DHF), Device Master Record (DMR), Device History Record (DHR)
Design History File (DHF), Device Master Record (DMR), Device History Record (DHR) Do you find yourself constantly struggling to create, manage, and maintain all of the information found in DHFs, DMRs, and DHRs - which is often redundant, repetitive, and chained together in a cumbersome way?
Speaker: Jose Mora | View Anytime | Price: $190.00 | View Details
Design History File (DHF), the Device Master Record (DMR) and the Device History Record (DHR) – Principles on Lean Documents and Lean Configuration
Design History Files (DHF), Device Master Records (DMR), and Device History Records (DHR) are key building blocks used in the design, development, manufacturing, and cGMP compliance for the Medical Device Industry. Too often, these are cluttered, confusing, and cause many errors due to the way they are created, organized, and managed.
Speaker: Jose Mora | View Anytime | Price: $190.00 | View Details
21 CFR Part 820 - Quality System Regulation - 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. Medical device manufacturing plants, required to follow 21 CFR Part 820, have the additional responsibility to ensure that each and every step of the manufacturing process is controlled by work instructions, SOPs, set-up instructions, equipment maintenance, and support functions, and that evidence of this work is maintained by controlled records.
Speaker: Jose Mora | View Anytime | Price: $190.00 | View Details
Design History File (DHF), the Device Master Record (DMR) and the Device History Record (DHR) – Principles on Lean Documents and Lean Configuration
Design History Files (DHF), Device Master Records (DMR), and Device History Records (DHR) are key building blocks used in the design, development, manufacturing, and cGMP compliance for the Medical Device Industry. Too often, these are cluttered, confusing, and cause many errors due to the way they are created, organized, and managed.
Speaker: Jose Mora | View Anytime | Price: $190.00 | View Details
21 CFR Part 820 - Quality System Regulation - 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. Medical device manufacturing plants, required to follow 21 CFR Part 820, have the additional responsibility to ensure that each and every step of the manufacturing process is controlled by work instructions, SOPs, set-up instructions, equipment maintenance, and support functions, and that evidence of this work is maintained by controlled records.
Speaker: Jose Mora | View Anytime | Price: $190.00 | View Details