Donna John Email & Phone Number

25 years experience in implementing and managing Quality Systems in a pharmaceutical, FDA-regulated company. Highly experienced manager of multiple Current Good Manufacturing Practices applications utilizing a Quality Systems approach to ensure ISO 13485;2016, and FDA (cGMP) compliance to 21 CFR Parts 11, 210, 211 & 820 especially in document control, change control, training, audits, corrective and preventive actions, non-conformance management (events/deviations), investigations, risk management, application validation, and stability system management. Successfully led all aspects of application adoption, from vetting options through configuration, training, validation, and implementation to comply with ISO/FDA/EU requirements.Specialties: cGMP Compliance, Software Validation, Learning / Training Management, Document Systems & Control, Records Management, Consumer Contact, Conflict Resolution, Audits, Product Technical Information, Product Liability Negotiations,

Listed skills include Gmp, Fda, Validation, Quality System, and 43 others.

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  Lynchburg

  Medical Laboratory