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Speaker Profile
JOSE IGNACIO MORA

José Mora is a Principal Consultant specializing in Manufacturing Engineering and Quality Systems. For over 30 years he has worked in the medical device and life sciences industry specializing in manufacturing, process development, tooling, and quality systems. Prior to working full time as a consulting partner for Atzari Consulting, José served as Director of Manufacturing Engineering at Boston Scientific and as Quality Systems Manager at Stryker Orthopedics, where he introduced process performance, problem solving, and quality system methodologies. During that time he prepared a white paper on the application of lean manufacturing methods to the creation and management of controlled documents and a template for strategic deployment. José led the launch of manufacturing at a start-up urology products company as Director of Manufacturing for UroSurge, Inc. at the University of Iowa’s business incubator park in Coralville, IA, creating a world-class medical device manufacturing operation, with JIT, kanban systems, visual workplace and lean manufacturing practices.


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$199.00
Design History File (DHF) Remediation using Principles of Lean Documents and Lean Configuration

 Jose Ignacio Mora
 December 12 2023
 01 : 00 PM EST    
 90 Minutes
Design History File (DHF) Remediation using Principles of Lean Documents and Lean Configuration

Does your DHF remediation process resemble the very mess that it is trying to resolve?The Design History File (DHF) is the objective evidence that a medical device was designed per design control guidance and applicable regulations and standards. While it is retrospective in nature, it is the end result of a process that begins with planning and ends with Design Transfer and has the Device Master Record (DM..

$199.00
Scrutinizing Test Method Validation (TMV) to Verify the Performance of a Medical Device

 Jose Ignacio Mora
 January 16 2024
 01 : 00 PM EST    
 60 Minutes
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.  Those who work with process optimization and validation..

$199.00
Effective Design of Experiments (DOE) Strategies

 Jose Ignacio Mora
 February 06 2024
 01 : 00 PM EST    
 60 Minutes
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 on the overall approach for successful DOEs. Attendees will learn:Effective DOE strategiesHow to capture the essence of a process?Using the right resolution at the right timeUse of DOEs during process validationHow to prevent "expert" bias when..

Showing 1 to 12 of 12 (1 Pages)
$200.00
Supervisor Accountability and Responsibility for Employee Safety and Health

 Jose Ignacio Mora
 Recorded Webinar
 90 Minutes
Supervisor Accountability and Responsibility for Employee Safety and Health

Running any business enterprise is tough enough on a good day. There are about 32.5 million small businesses in the US, which account for 99.9 percent of all US businesses (SBA, 2021). The Small Business Administration (SBA) defines a small business as a firm that has fewer than 500 employees. This metric will be the focus of our discussion. And that’s a big number How a business or organization approaches ..

$200.00
Sampling Plans for Verification, Validation and Production

 Jose Ignacio Mora
 Recorded Webinar
 90 Minutes
Sampling Plans for Verification, Validation and Production

This presentation shall describe how to create Sampling Plans for verification and validation, production process validation and production control. The webinar will include the theoretical background of sampling, several examples and formulas for easy construction of sampling plans.Areas CoveredBasic Statistics The main parameters that should be considered Formulas related to SamplingSampling StandardsCour..

$200.00
The FDA Inspection: From SOP to 483

 Jose Ignacio Mora
 Recorded Webinar
 60 Minutes
The FDA Inspection: From SOP to 483

This session will discuss how to prepare for the inspection, what to do during the inspection and the close-out interview, and how to respond to the inspection. Also contained in this session will be the limits of FDA's scope during an inspection, including what documents you are not required to show them, and the permissibility of photographs and affidavits.Areas CoveredTypes of inspectionsPreparationDedic..

$200.00
Understanding Supply Chain Management Concepts

 Jose Ignacio Mora
 Recorded Webinar
 90 Minutes
Understanding Supply Chain Management Concepts

Supply chain management is a concept that has evolved over many years, beginning with the implementation of materials management in the 1980s. Materials management integrated those functions involved in the management of materials and suppliers, such as procurement, demand planning, warehousing, forecasting, production planning and scheduling, manufacturing, inventory management, transportation, and custome..

$200.00
FDA Regulation of Artificial Intelligence/Machine Learning

 Jose Ignacio Mora
 Recorded Webinar
 60 Minutes
FDA Regulation of Artificial Intelligence/Machine Learning

AI/ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective. FDA has regulated medical software by means of regulation and guidance for years, however, AI/ML programs fall outside the scope of these regulations and guidance. This happens because the FDA approves the final, validated version of the software. The point of AI/ML is to learn and update the ..

$200.00
How to Conduct a Human Factors/Usability Validation

 Jose Ignacio Mora
 Recorded Webinar
 60 Minutes
 Download Catalog
How to Conduct a Human Factors/Usability Validation

This webinar will explain the procedure described in ISO62366 and the 2016 FDA Guidance for compliant human factors/usability validation. HF/U validation is very different from device validation. For example, success criteria are qualitative rather than quantitative as is in device validation. Claiming success because eg. 95% of test participants did not commit a user error is not valid. Nor is 10..

$200.00
IEC 62304 for Medical Device Software

 Jose Ignacio Mora
 Recorded Webinar
 60 Minutes
 Download Catalog
IEC 62304 for Medical Device Software

This course is essential for Medical Device companies interested in submitting software enabled medical Devices or Software as a Medical Device to the FDA for 510K approval. One of the biggest risks most company's face when submitting their device for approval is finding out after seven or more months of waiting that the 510K has been denied because the software portion of the submittal is inadequate and no..

$200.00
Managing The Audit Function In A Global Company

 Jose Ignacio Mora
 Recorded Webinar
 90 Minutes
 Download Catalog
Managing The Audit Function In A Global Company

Whether your company is small or large each should have at least one independent yet experienced individual or department that can be relied on to resolve issues from these and other perspectives: quality assurance, regulatory affairs, and corporate risk management. While companies rely on audits to remain in compliance everyone is eventually faced with a complex issue that requires examination from an..

$200.00
Medical Device Regulations in the Middle East and North Africa Region

 Jose Ignacio Mora
 Recorded Webinar
 90 Minutes
 Download Catalog
Medical Device Regulations in the Middle East and North Africa Region

This seminar will provide an essential overview of the key areas of requirements for product approvals for medical devices in the Middle East and North Africa. The programme will cover the regulatory requirements and developments in the individual countries such as Algeria, Bahrain, Egypt, Iran, Iraq, Jordan, Kuwait, Lebanon, Libya, Morocco, Oman, Palestine, Saudi Arabia, Sudan, Syria, Tunisia, UAE, and Yem..

Showing 1 to 12 of 12 (1 Pages)