Due to the growing importance of regulatory compliance, the increasing international harmonization, and the potential consequences, many pharmaceutical manufacturers have adopted a program of internal audits to find and correct areas where the facility is not in full compliance with the cGMP regulations. This allows corrections before a regulatory body audit.
Objectives of the Presentation
Why Should you Attend
- The need, purpose, cost and benefits
- Principles of auditing
- Establishing, Implementing and managing a quality audit program
- The audit cycle - initiating, preparing, conducting, reporting, the wrap up, and follow up
- Auditor competence evaluation - practice, behavior, knowledge and skills
- Auditor evaluation - criteria, evaluation methods, improving
Pharmaceutical and medical device companies are legally bound to ensure that regulated quality compliance standards are consistently maintained, with potentially severe business and legal consequences for certain failures. Regular internal audits are the best practice to meet and maintain compliance in changing manufacturing and regulatory environment before a potential critical discovery by an FDA audit. This is also a smart practice to improve efficiencies, especially during a product life-cycle.
This webinar will review this process and discuss best practices of an effective internal auditing program, and how to add overall value to the company.
Who will Benefit
- Regulatory expectations and rights
- Expectations and benefits of good program and auditing
- How to design and conduct an objective and effective audit
- Auditing of business structure, facilities, personnel, records, laboratories, environment and validation
- Effective management interaction and communication
- The report and follow-up
This is especially important to regulated and / or quality critical product development companies such as pharmaceutical and medical device companies
- Quality Assurance/Auditors - Program overview; initiating, preparing for, conducting, reporting, closing, cycle
- Supervisors - Preparing for, participating in, responding to an audit
- Managers - Preparing for, participating in, responding to an audit
- Directors - Preparing for, participating in, responding to an audit
- VPs of Product Development, Manufacturing or Quality
This is especially important to regulated and / or quality critical product development companies such as pharmaceutical, biopharmaceutical and medical device manufacturing plants in the U.S., or shipping product for sale in the U.S.
Compliance to an effective quality management system is both a critical regulatory requirement and is an expectation in doing business, without which a company can be shut down due to noncompliance or may fail due a poor reputation in the marketing of its products. Ensuring that compliance, quality and efficiencies are maintained, an effective internal auditing program are recommended, with regulatory guidances describing suitable expectations. This includes those produced by the FDA, ICH and ISO regulatory bodies. These guidances and principles are discussed in this webinar examining a good and effective internal audit system to reinforce quality expectations and efficiencies.