When developing the quality audit, there are a number of requirements and expectations that must be met. These include technical, regulatory, quality, responsiveness, location, readiness, and those less defined but critical. This webinar is designed to provide the participants a working knowledge of quality audits. The why, when, who, how, and what of conducting a quality audit will be reviewed to ensure that your organization is capable of meeting all of the regulatory expectations.
Why You Should Attend:
Many organizations conduct quality audits because they are required to do so by their company or a regulatory agency. Others conduct the audits because they have been a good check for compliance to the regulatory standards.
While all of these reasons have varying degrees of validity, none of them articulate the best reason for having a robust quality audit program. A good quality audit program should allow an organization to assess and periodically re-affirm the ability of its departments to provide conforming product consistently, reliably and compliantly. It should be one of the most important initiatives toward fulfilling the goal of having a sustainable quality culture.
Areas Covered in the Session :
- Overview of Regulatory Requirements for Quality Audits
- Purpose of Quality Audits
- Audit Preparation/Audit Plan
- Conducting the Audit
- Introductory Meeting/Orientation
- Area Tours
- Document Review
- Time Management
- What is/is not an Audit Finding?
- Classifying Audit Findings
- Audit Wrap-Up Meeting
- Key Elements of the Audit Report
Who Should Attend:
- Quality Departments
- Manufacturing Departments
- Engineering Departments
- Operations Departments
- Production Departments
- All levels of management
Course Director: DANIELLE DELUCY
Danielle DeLucy, MS, is owner of ASA Training and Consulting, LLC which provides Pharmaceutical and Biologics based companies with training and quality systems assistance in order to meet Regulatory compliance.
Prior to this role, Danielle has been in the industry for 15 years serving in numerous Quality Management Roles, such as the Director of Product Quality, the oversight of Sterility Assurance practices and provided QA oversight of numerous filling and packaging operations.
Danielle began her QA career as a Quality Control Pharmaceutical Microbiologist at a contract laboratory where she performed various tests for their clients. In the years after, she has held positions in the Quality management arena while increasing her responsibility. She has helped to lead many Regulatory Health Inspections and was instrumental in the coaching process of her peers prior to any inspection.
Currently, Danielle assists companies who are faced with warning letters, consent decrees and those wishing to improve compliance establish more robust quality systems so that the company can succeed.