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About Teresa Cain

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So far Teresa Cain has created 135 blog entries.

AAMI Virtual Event – Corrective & Preventive Action Requirement & Industry Practice – June 27-28, 2022

This 2-day course provides intensive coverage of the elements of a corrective and preventive action (CAPA) system. Some primary topics include: the purpose of a CAPA system and how it is integrated throughout a Quality Management System; appropriate data sources and how to coordinate, analyze and manage them; methods for verifying and / or validating actions; [...]

2022-06-16T21:11:09+00:00June 16th, 2022|

AAMI Course – Medical Device Cybersecurity 101 for HTM Professionals (Exchange 2022) – June 3, 2022 in San Antonio, TX

Today the news is inundated with stories about cybersecurity compromised businesses, public services, and government operations.  Among those we often hear as being compromised are hospitals and healthcare-related organizations.  When compromises to healthcare organizations do occur, they have frequently shut down a department’s or an entire organization’s operations so that their ability to deliver healthcare [...]

2022-05-23T19:43:23+00:00May 23rd, 2022|

AAMI Virtual Course – Industrial Sterilization for Medical Devices – May 10-13, 2022

Industrial Sterilization for Medical Devices is a comprehensive 4-day course covering essential information on sterilization technologies and methods, sterilization standards, FDA requirements, critical factors in product design and product release decisions, and much more.  Participants will learn how to apply the principles of sterilization and address requirements during product design. Participants will also determine how [...]

2022-04-27T20:52:10+00:00April 27th, 2022|

AAMI Virtual Course – Quality System Regulation 21 CFR 820 and ANSI/AAMI/ISO 13485 – April 18-22, 2022

This 4.5 day course is the culmination of years of consensus development on the part of a respected group of quality system experts from leading device manufacturers, the FDA, industry consultants, and members of International Organization for Standardization (ISO) standards development teams. Participants will learn how to develop and maintain a quality system program that [...]

2022-04-19T21:24:24+00:00April 19th, 2022|

AAMI Course – Process Validation Requirements & Industry Practices – April 6-8, 2022

This 3-day course provides attendees with practical tools and techniques for process validation requirements for FDA’s Quality System Regulation and recognized process validation guidance from the Global Harmonization Task Force. The program includes industry best practices and real-life process validation examples. Topics include planning, protocol development, validation execution, monitoring & control and re-validation to meet [...]

2022-03-26T19:27:07+00:00March 26th, 2022|

AAMI Course – Ethylene Oxide Sterilization for Medical Devices – March 22-25, 2022

This highly interactive 3.5-day, advanced course assumes that participants are experienced in working with an established ethylene oxide sterilization process but are now challenged with ensuring the continued effectiveness and assessing change for the product or process. The program combines classroom lecture with real-life scenarios to illustrate concepts and situational analyses that provide participants with [...]

2022-03-08T21:00:30+00:00March 8th, 2022|

AAMI Training – Navigating 510k and De Novo Requirements – March 1-4, 2022

This 4-day course will navigate the 510(K) clearance process and De Novo classifications requests for United States (U.S.) and global Medical Device Manufacturers and regulatory affairs leaders to improve the ability to bring new and improved devices to the U.S. marketplace. Course Audience •    U.S. and global (e.g., European Union, Association of Southeast Asian [...]

2022-02-23T19:51:34+00:00February 23rd, 2022|

AAMI Course – Integrating Risk Management into the Product Life Cycle – February 9-11, 2022

This comprehensive 3-day course for medical device manufacturers presents risk management concepts used throughout the quality system that can help your organization meet FDA, ANSI/AAMI/ISO 14971 and ANSI/AAMI/ISO 13485:2016 requirements for risk management. This course covers the use of risk management principles throughout the life cycle of the product, from design…to manufacturing…through post-production to retirement. Instructors [...]

2022-02-06T21:34:44+00:00February 6th, 2022|

AAMI – Introduction to Combination Products and Regulations: A Risk-Based Approach / Expert Susan Neadle – February 2, 7, 9, 14, 16, 21, 2022 / 1:00-3:00 pm ET

From software as a medical device, to the growing field of biologics, to the enhancement of medical devices with medicinal substances, the scope of products considered combination products continues to expand.   Join industry-renowned instructor Susan Neadle to deepen your understanding of the ever-evolving regulatory landscape of combination products, including navigating and applying requirements and [...]

2022-01-26T18:29:08+00:00January 26th, 2022|

AAMI Course – Quality Systems Regulation 21 CFR and ISO 13485 – January 31, 2022 – February 4, 2022

This 4.5 day course is the culmination of years of consensus development on the part of a respected group of quality system experts from leading device manufacturers, the FDA, industry consultants, and members of International Organization for Standardization (ISO) standards development teams. Participants will learn how to develop and maintain a quality system program that [...]

2022-01-23T19:48:58+00:00January 23rd, 2022|