Warning Letters due to Lack of Comprehension 2017

A timely, well documented, Corrective / Preventive Action program validates a quality system that is not only capable of identifying potential problems but also effectively correcting problems when incidents do occur and as part of the Continuous Quality Improvement program, correcting potential problems prior to occurrence. Adequate incident tracking is the primary foundational element for an effective CAPA system.

Why should you Attend:

A vast majority of the current industry deficiencies which have led to isolated 483s, Warning Letters and Consent Decrees are the result of deficient technical documentation and effective means of assessing various elements of CAPA expectations for products produced and distributed under the FDA regulations.

Areas Covered in the Session:

• Identification of the incident-Criticality of the Incident Tracking System separate from deviation tracking.
• Evaluation of the impact or magnitude of the incident
• Initiation and Risk Assessment to demonstrate compliance with Quality Systems Regulations
• Investigation procedure to assess various strategies in accordance with current regulatory expectations
• Root Cause Analysis avoiding subjective thinking to generate objective documentation.

Who Will Benefit:

• Inspectors
• Auditors
• Quality and Documentation Personnel within the industry as well as Regulatory
• Quality
• Operations and Development

Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: [email protected]