Course Description:
This course is ( not “will be”) based on corporate procedures for audits and FDA requirements/expectations for audit programs. Conceptually, it will be applicable to all industries. It has been designed to set forth elements of auditing compliance with regulations, company procedures, and generally recognized good business practices. The subject matter is applicable to internal, external (supplier/contractor) and due diligence audits.
This seminar will discuss comprehensive coverage of a quality system along with a more efficient, targeted approach. Basic elements of auditing laboratories, computer systems, design controls, and validation will also be reviewed. Further, the course will:
- Define fraud, identify fraud indicators, and contrast fraudulent activities with what amounts to poor performance.
- Provide a standard against which a company’s current audit procedures can be evaluated.
- Discuss the use of checklists and draft letters and many of them will be embedded into visuals as examples.
- Demonstrate how organizations that lack an audit program can adopt the audit procedures detailed in the course or use them as a basis for developing their own procedures.
- Include a workshop with small groups to consider real audit situations and discuss approaches to dealing with them.
Seminar instructor Bill Schwemer is an ex-FDA official with more than 50 years of experience in dealing with FDA compliance matters that include 30 years he spent working with the FDA as a field investigator, director of field investigations, assistant associate commissioner for regulatory affairs, and special assistant to deputy commissioner for policy.
Learning Objectives:
- Recognize the elements of an effective, efficient audit program that are included in:
- Program Management
- Conduct of Audits
- Reporting Findings
- Understand the knowledge, skills and/or abilities needed for performing audits.
- How to evaluate documents and records that compose a quality system.
- What to look for when performing audits against company policies, regulatory requirements, and other standards.
- Enable an audit team to find weaknesses that should be corrected before they are found during a regulatory inspection.
- Identify opportunities for participants and their staff to improve audit programs.
- Learn how audit findings can be scored to measure improvement or regression from one audit to another.
- How to spot apparent fraud, but not confuse it with sloppiness or poor performance.
- Understand the importance of communications between auditors and those audited; then maintaining open, cooperative relationships following audits to resolve issues.
Who Will Benefit:
- Corporate, site, and department managers responsible for reviewing audit resource needs and budgeting.
- Senior managers wishing to improve communications between corporate or site auditors and the businesses or departments audited.
- Quality, regulatory, and purchasing department personnel who base decisions on audit findings.
- Audit program managers looking for more efficient and effective approaches.
- Managers, supervisors, quality assurance staff, technical specialists and others who are assigned to audit teams.
- Supervisors and managers that host regulatory inspections and customer auditors
