This Internal Quality Audit webinar is presented as a practical way for an organization to evaluate its internal audit program and make required improvements.
FDA regulations and ISO 9000 standards require each organization to establish and maintain an audit program that reviews the quality system.Audits must be conducted according to an established schedule. Audit schedules are determined based on the status and importance of the areas or functions being audited. Audit findings must be documented, and those responsible for the area or function being audited, must be informed of the results. Audit findings must be followed up to verify and document the implementation and effectiveness of corrective and preventive actions taken. All areas or functions should be audited at least once each year. An effective internal audit program provides assurance that the organization is consistently operating in a state-of-control and is implementing corrective actions when nonconformance’s are found. An optimal audit program detects potential problems and provides a major pathway for implementing preventive actions.
Areas Covered in the seminar:
- Definitions and context of audit terminology
- General guidelines on areas or functions to be audited
- Auditor qualifications
- Audit schedules
- Audit preparation: documentation, checklists and notification
- Conducting the audit
- Audit findings and reports (draft and final) and inputs to CAPA
- Audit tracking, follow-up actions and status reports
- Audit records and files
- Disclosure of internal audit findings
Who Will Benefit:
- Executive Management
- Quality Managers
- Regulatory Affairs Managers
- Program Managers
- Project Managers
- Product Development Managers
- Research and Development Managers
Instructor Profile:
Ron Schoengold, is a consultant to the biotechnology and medical device industry, offering quality solutions, and critical technical and business information on the commercialization and maintenance of products and services. He has been an active contributor to the industry for over 38 years and has developed commercially successful screening and diagnostic products for gastroenterology, infectious disease and point-of-care testing. Schoengold is a principal advisor and mentor for the Larta Institute which is supported by the National Institutes of Health (NIH), Commercialization Assistance Program (CAP), for companies awarded SBIR and STTR grants. Schoengold has published, presented or contributed to more than 16 scientific journal articles, co-authored a book chapter on point-of-care testing and holds 8 patents related to point-of-care diagnostics. He earned his bachelor’s degree in biology and chemistry, did his master’s training in microbiology and biochemistry and completed additional graduate studies in microbiology, genetics, molecular biology and immunology.
