Course Description - Course runs 9:00 to 5:00 both days (Breakfast & Lunch Included)

A robust audit program is a key stone of an effective Quality System. The need for internal (self-inspection) quality auditing has been recognized, and is required, by all active pharmaceutical ingredient (API)/bulk pharmaceutical chemical, medical device and finished pharmaceutical cGMP regulations published worldwide. In addition it is starting to become the industry expected "norm" in the area of pre-market clinical development.

Experience reveals that many internal company quality audits and many external supplier/contractor quality audit programs are ineffective. This course provides the rationale, strategies, techniques and tips, on how to plan and perform effective audits.

The course explores the politics, psychology and all the technical aspects of auditing, including discussions of their logistics, tools, and frequency. The course evaluates the talents and personnel characteristics required of those who consistently perform thorough audits which yield optimal compliance results.

The name of the game is effecting change. Determining operational deficiencies is only one aspect of an audit. The key issue is how to effect change to bring about compliance to company and legal standards. This course considers how to effect change and how to make audits a positive experience for the auditor and auditee.

Who Should Attend

This two-day course is designed for quality managers, quality auditors, regulatory/compliance professionals, production managers and top management interested in learning the value of an effective internal and external quality audit system. Those interested in how to prepare for a QA audit and how to enhance their internal/external quality audit system as a valuable regulatory compliance tool will also benefit from this course. Consultants and government inspectors will find this course particularly useful in enhancing their inspections and capabilities.

Lee Truax-Bellows, MS, FNP, CCRA, RQAP-GCP

Specialties: Regulatory

Lee Truax-Bellows is a founder, President and CEO of Norwich Clinical Research Associates Ltd. (NCRA). This full-service clinical CRO in upstate NY consults on study development, monitoring and analysis; clinical and data-management-department development; regulatory consulting; SOP consulting; GCP and clinical regulatory training/auditing services.

Lee has over 20 years of experience in the pharmaceutical and medical device industries; having served as Monitor, Medical Communications Associate, Project Manager, Senior Quality Auditor, Senior Trainer and Regulatory/SOP Consultant in both industry and CRO roles.

Ms. Truax-Bellows received her MS in Nursing Administration/Advanced Nurse Family Practitioner from SUNY Binghamton, her MS in Nursing Administration/Family Nurse Practitioner from Binghamton University School of Management and her BS in Nursing from Hartwick College.

Lee is an active member of the Association of Clinical Research Professionals, the New York State MedTech Association and the Society of Quality Assurance (SQA). She is a Certified Clinical Research Associate and a Registered Quality Assurance Professional in Good Clinical Practices.