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.
Jose Ignacio Mora
Recorded Webinar
60 Minutes
How to Prepare for an OSHA Audit
An OSHA inspection provides a view into your organization’s safety culture. This training will share a step-by-step guide on how to strategically prepare for a safety audit before it happens, which includes newly defined rules that employers need to know. Additionally, this training will help attendees understand the key differences between The employer's rights vs. The Employee’s rights during an OSHA insp..
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 ..
Jose Ignacio Mora
Recorded Webinar
60 Minutes
Continues Improvements using 7 Basic Quality Tools
The Seven Basic Quality Tools, also known as “The original seven” or “The basics for Quality job” or “Must-know Quality Tools” as well as the most frequently used Quality tools, were first promoted by Kaoru Ishikawa, a professor of engineering at Tokyo University and the father of "quality circles." These tools, while there can be slight variations, include a Cause-and-effect diagram (also called Ishikawa o..
Jose Ignacio Mora
Recorded Webinar
60 Minutes
Current Good Manufacturing Practices
Current Good Manufacturing Practices, which include current good documentation practices, and elements of continuous improvement are both a law (regulations) and the right thing to do for any manufacturing operations.During this webinar, we will focus on 15, basic-to-intermediate, practices, including what they mean, how they work together, and why they stimulate continuous improvement (and yes, they do not..
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..
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..
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..
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..
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..
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..
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..