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Instructor Profile
John E Lincoln
consultant,

consultant, has successfully designed, written and run all types of qualifications/validations, which have passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide. John has also managed pilot production, regulatory affairs, product development/design control, 510(k) submissions, risk management per ISO 14971, and projects; with over 27 years of experience, primarily in the medical device industry – working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco/Mallinckrodt. He is a graduate of UCLA.
Trainings By John E Lincoln
10 Steps to Effective Risk Analysis for US FDA and ISO 14971 Compliance
Category: Medical Devices , FDA Compliance

Risk-Based Verification and Validation Planning to Meet US FDA and ISO 13485 Requirements
Category: Medical Devices , Risk Management , FDA Compliance , FDA Validation

Change Control - Implementation and Management
Category: Medical Devices , General Manufacturing

Documenting a Risk-Based Quality System - for Compliance and Cost-Savings
Category: FDA Compliance

Risk-Based CAPA Systems
Category: Medical Devices , General Manufacturing


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Alyssa Martin
Alyssa Martin has over 18 years experience in public accounting, including 11 years of internal control process risk management, and she serves as the Director of the firm's Risk Advisory Services. Ms. Martin's practice emphasis is in the areas of operational analysis, risk management, internal audit, IT audit, business management consulting, strategic planning, and technology consulting for public sector, private sector and publicly held companies.

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