Internal Auditing for the Medical Device Industry
Course "Internal Auditing for the Medical Device Industry" has been pre-approved by RAPS as eligible for up to 12 credits towards a participantīs RAC recertification upon full completion.
Overview: This course provides an overview of internal auditing requirements and techniques for medical device companies as a method for risk management and quality improvement.
The course will cover auditing requirements, audit planning, preparation, knowledge, auditor skills, interviews, documents and records review, objective evidence, audit report writing and corrective action.
Why should you attend?
Attendees should attend this seminar for risk management and improvement purposes to identify weaknesses, problems, compliance risks, and improvement opportunities.
Day 1 Schedule:
Lecture 1: Overview of an auditing program, principles of quality management systems and how they related to auditing, benefits of auditing, and what is auditing.
Lecture 2: Types of audits, auditor qualifications, ethics, responsibilities, audit phases, audit planning, and scheduling.
Lecture 3: Conducting audits, interview techniques, objective evidence, data collection, tracing, use of checklists, and reviewing documents and records.
Lecture 4: Conducting process audits, running closing meetings, audit report writing, corrective actions, and improvement
Day 2 Schedule:
Lecture 1: Overview to auditing to ISO 13485 and FDA QSR. Global differences which affect auditing approaches, auditing document control and record keeping, management responsibility, and resource management.
Lecture 2: Auditing order handling, design control, purchasing, and supplier controls.
Lecture 3: Auditing production, validation, and preservation. Inspection and testing, control of test equipment, customer property, and sterilization
Lecture 4: Auditing customer feedback, internal auditing programs, complaints, recalls, adverse events, and corrective and preventive action
Director Regulatory and Quality at Sekisui American Diagnostica
Joseph Azary has over 25 years of quality and regulatory experience in the medical device industry. Joseph is currently the Vice President of Quality Assurance & International Regulatory Affiars at Z-Medica, LLC.