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FDA - Streamlining Your Internal Auditing Process
This webinar will provide the information you need to know to:
- Develop or update a risk-based internal auditing system that is compliant to FDA cGMP/ Quality System Regulation and ISO 13485
- Manage an Internal Audit system
- Understand the difference between internal and external audits
- Learn how the internal auditing system can add value to your quality system and your company
- Understand what makes a good internal audit
- Understand the skill required for an internal auditor
- Understand what the FDA must see to verify that you are conducting your internal audits as required
Overview of the webinar
Internal audits are required by both the FDA and ISO 13485. This webinar will cover how to create a Risk-based, value-added internal auditing system for compliance with FDA and ISO 13485 internal auditing requirements. It will include how to set up and manage the auditing system, how to plan a realistic annual internal audit schedule that covers all the requirements of your company’s quality system, as well as an overview of how to conduct an internal audit, and document the results. This webinar will explain how the principles of risk can be incorporated into your audit program without adding a lot of additional audits, thus reducing your risk of non-compliance. It will discuss the value of a good internal auditing program in reducing compliance risk of all types.
Who should attend?
- Audit Manager
- Internal auditor
- Supplier Auditor
- Quality Manager
- Regulatory compliance manager
- Supplier auditors
- Quality engineer
- Quality Consultant
Why should you attend?
Does your current auditing program assure that you are efficiently meeting all FDA quality and regulatory requirements, such as labeling and premarket clearance? Does it assure that you are meeting all European and Canadian requirements if you sell products in those areas? If not or if you do not know, this seminar will explain how these are incorporated into your audit program without adding a lot of additional audits, thus reducing your risk of non-compliance. By using a risk-based approach to your auditing program, you can focus on those areas where you are most at risk but still cover all your auditing requirements.
Faculty - Miss.Danielle Delucy
Danielle DeLucy, MS, is the 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.