Critical Role of Quality Audit in GxP Compliance & Improvement

Why Should you Attend:

Manufacturers need to establish procedures for quality audits and conduct such audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system as well as assessing your GCP, GLP and GMP programs. Quality audits need to be conducted by individuals who do not have direct responsibility for the matters being audited. Corrective action(s), including a reaudit of deficient matters, need to be taken when necessary. A report of the results of each quality audit, and reaudit(s) where taken, will be made and such reports certainly will be reviewed by management having responsibility for the matters audited. The dates and results of quality audits and reaudits must be documented. This Webinar will address the key elements on being an effective auditor for your company covering the different types of audits, what do audits measure and how are audit results measured and certainly why perform audits to begin with. Learn the basic skills required and how to apply them and the knowledge in becoming more effective.

Areas Covered in the seminar:

• Understand that audit preparation is critical and how to generate the audit plan.
• Learn the different type of audits and how to prepare, execute and close out the audit.
• Selecting your auditor or audit team and knowing the source of authority for conducting the audits.
• Development of checklists and using data collection methods.
• Know the expectations for audit performance, execution and auditing techniques.
• Understand the rules and expectations for audit reporting, corrective action, follow-up and closure .
• Learn the Do’s and Don’ts when auditing as related to FDA investigators/inspectors during inspections at your facilities.
• Understand the code of ethics, expectations, and how to write an effective audit report summarizing your findings.

Who will benefit:

This webinar will provide valuable assistance and guidance to all regulated companies that are preparing for different type of audits, whether internal or external. The employees who will benefit include:

• All levels of Management for all departments and those who desire a better understanding how the process works
• QA/QC/Compliance/Regulatory Affairs
• Auditors
• Engineering/Technical Services
• Consultants
• Operations/Manufacturing

Instructor Profile:

David R. Dills, as of recent, joined Keller Medical, Inc. as Director of QA & Regulatory Affairs with increasing responsibilities covering all aspects of the global regulatory landscape and the quality management system. He also an independent Quality, Regulatory & Compliance Consultant, with an accomplished and proven track record has 21+ years of hands-on experience with emphasis on Class I/II/III medical devices, In Vitro diagnostics and pharma in the areas of QA, Regulatory Affairs and Compliance.

Since 2000, has provided consultative services on behalf of global clients and subcontracted by third-party providers and provides services involving all stages of the product development, submission and commercialization process, inspection readiness preparation, audits/assessments, remediation and regulatory strategies, postmarketing surveillance, clinical affairs, developing/remediating quality management systems, device registrations, as well as ISO 13485 certification and CE Marking activities. He has been previously employed by well-known global medical device manufacturers and service providers, serves on several industry advisory boards, is a prolific speaker at various events and venues and publishes articles on a range of topics.

Manages quality, regulatory and compliance projects with multiple competing priorities having a direct impact on site operations/commercial opportunities. Develops strategies for governmental approval to introduce new products to market, provides guidance/counsel on regulatory and compliance requirements and prepares/reviews submissions and dossiers/technical files, including device applications/registrations for Pacific Rim, The Americas and EU, and involved in establishing/deploying QA systems with emphasis on preventing the design, manufacture, and shipment of defective products. Manages QS and regulatory problems (e.g. adverse events, MDRs, Agency enforcement and complaints) related to development, manufacturing, and commercialization, and recommends action to senior leadership to ensure effective resolution for manufacturers to achieve sustainable and proven compliant systems and postmarketing tasks.

Background encompasses broad capabilities in quality systems development/deployment, documentation remediation, validation, regulatory, and interfaces with FDA, EMEA/MHRA/PMDA/TGA, MDD/IVDD/CE Mark, ICH, ISO 14971/13485, and demonstrates credible experience to maximize performance/optimizes business performance through proactive strategies to mitigate compliance exposure. Represents companies to regulatory agencies and facilitates company decision making by framing issues, presenting options, remediation and objective business advice. Works effectively across functions for overall corporate compliance to support company’s goals and strategies.

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