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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
Risk Management for Medical Devices per ISO 14971

 Jose Ignacio Mora
 April 17 2025
 01 : 00 PM EST    
 60 Minutes
Risk Management for Medical Devices per ISO 14971

Risk management overarches projects associated with a particular product family, given that risks will both remain and change as new design features and medical indications for use evolve with a particular device.During all phases of a project, any new consideration must be held up against the scrutiny of potential risk and harm to the health of people, damage to property, or the environment during all stag..

$199.00
Best Practices for a Compliant, Lean Supplier Management Program

 Jose Ignacio Mora
 April 18 2025
 01 : 00 PM EST    
 60 Minutes
Best Practices for a Compliant, Lean Supplier Management Program

Notified bodies and the FDA cannot require your suppliers to meet the quality system regulations, so they must make sure you are exercising sufficient control over those suppliers. You must make sure your supplier management and system meets all required regulations, especially for critical suppliers. Sure, you depend on your suppliers to provide you with goods and services, but can your system prove that y..

$199.00
Unlocking Manufacturing Effectiveness: Practical Strategies for Overcoming Production Constraints

 Jose Ignacio Mora
 May 28 2025
 01 : 00 PM EST    
 60 Minutes
Unlocking Manufacturing Effectiveness: Practical Strategies for Overcoming Production Constraints

In today’s fast-paced manufacturing environment, being busy doesn’t always translate to being productive. Operations that appear smooth on the surface may in fact be stagnant—or even declining—in terms of output. The hidden culprit is often an overlooked constraint or bottleneck quietly limiting the entire system’s performance.In this session, industry expert José Ignacio Mora shares a practical approach in..

$199.00
Process Validation Requirements And Compliance Strategies

 Jose Ignacio Mora
 June 09 2025
 01 : 00 PM EST    
 60 Minutes
Process Validation Requirements And Compliance Strategies

When used as intended, process validation can provide increased process reliability, improved yields, and reduced operating expenses.Areas CoveredGlobal Harmonization Task Force requirements (includes FDA and ISO)Installation Qualification (IQ)Operational Qualification (OQ)Performance Qualification (PQ)Design QualificationFacilities and utilitiesStrategies for achieving a robust and reliable process.Typical..

$199.00
Risk-based Design Control - The New Paradigm for Medical Device Design

 Jose Ignacio Mora
 July 09 2025
 01 : 00 PM EST    
 60 Minutes
Risk-based Design Control - The New Paradigm for Medical Device Design

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 awkwardly, this webinar will give you a different perspective and a very different approach that you can use.If your design and manufacturing resources spend too much time on documentation and no..

$199.00
Supplier Quality Remediation using Principles of Lean Documents and Lean Configuration

 Jose Ignacio Mora
 August 12 2025
 01 : 00 PM EST    
 90 Minutes
Supplier Quality Remediation using Principles of Lean Documents and Lean Configuration

Which do YOU want to be?  Only you can answer that.  This webinar can show you how to be the latter:Old school remediation:    Hire 50 consultants tribal knowledge    Put them to work on a PUSH system    Build mountains of work-in-progress    Bury your information in folders    Spend endless hours on rew..

Showing 1 to 13 of 13 (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
Export Due Diligence: What Every U.S. Exporter Must Know?

 Jose Ignacio Mora
 Recorded Webinar
 60 Minutes
Export Due Diligence: What Every U.S. Exporter Must Know?

Provisions in the Export Administration Regulations (EAR) require that exporters know their exports, destinations, end-users, and end uses. Exporters must submit an individual validated license application if the exporter "knows" that an export that is otherwise exempt from the validated licensing requirements is for end-uses involving nuclear, chemical, and biological weapons or related missile delivery sy..

$200.00
Management Accounting and the Cost of Quality

 Jose Ignacio Mora
 Recorded Webinar
 60 Minutes
Management Accounting and the Cost of Quality

Managing quality is an imperative for any organization to remain competitive. Measurements of quality are essential, however supplementing that information with financial information further adds to success in managing quality.Ultimately the language of money is what executives and managers rely on to make better decisions.Unfortunately, most financial reporting neglects to report quality information such a..

$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 StandardsWho..

$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 13 of 13 (1 Pages)