Course Description -
A robust audit program is a key stone of an effective Quality System. The need for internal (self-inspection) quality auditing has been recognized, and is required, by all active pharmaceutical ingredient (API)/bulk pharmaceutical chemical, medical device and finished pharmaceutical cGMP regulations published worldwide. In addition it is starting to become the industry expected "norm" in the area of pre-market clinical development.
Experience reveals that many internal company quality audits and many external supplier/contractor quality audit programs are ineffective. This course provides the rationale, strategies, techniques and tips, on how to plan and perform effective audits.
The course explores the politics, psychology and all the technical aspects of auditing, including discussions of their logistics, tools, and frequency. The course evaluates the talents and personnel characteristics required of those who consistently perform thorough audits which yield optimal compliance results.
The name of the game is effecting change. Determining operational deficiencies is only one aspect of an audit. The key issue is how to effect change to bring about compliance to company and legal standards. This quality auditing course also considers how to effect change and how to make audits a positive experience for the auditor and auditee.
Who Should Attend
This two-day quality auditing course is designed for quality managers, quality auditors, regulatory/compliance professionals, production managers and top management interested in learning the value of an effective internal and external quality audit system. Those interested in how to prepare for a QA audit and how to enhance their internal/external quality audit system as a valuable regulatory compliance tool will also benefit from this course. Consultants and government inspectors will find this course particularly useful in enhancing their inspections and capabilities.
Course Agenda
First Day
Overview and general considerations:
- Scope and purpose of the internal and external Quality Audit System
- Regulatory background – requirements for each type of operation
- Understanding the politics of auditing
- Auditing / Regulatory Inspections – the tie-in
Contractor and supplier audits
- When to audit – initial evaluation versus re-certification
- Steps for conducting supplier audits
- Problem resolution audits
What makes a good audit?
- Audit objectivity
- Auditing standards
- Creating a win-win audit - turning the audit into a positive coaching experience for yourself, your company, and those you are auditing
Selling quality assurance audits to management
- Learn why top management should care about audit findings
- Discover how to get management to listen, buy-in, and take action on your audit findings
Audit System
- Define responsibilities
- Ensure auditor qualifications and training
- Developing an audit schedule – Risk Based
- Preparation for the audit (developing audit conduct tools):
- Audit Plans
- Audit Checklists
- Review of past history and additional background data
- Auditor Best Practices:
- Key questions
- Techniques
- The importance of documentation
- Listening & observation skills
- What to do and what not to do
- Conclusion-Audit reports
- Categories of observations
- Effecting change
Audit Follow-Up and Closure
- Follow-up and final documentation
- Audit Closure
- Audit Reports
- Relation to CAPA
Second Day
Conducting Audits
- Review key areas for each type of audit focus. Will include what to look for and questions to ask when conducting the following types of audits
- Good Clinical Practice Audits
- Planning
- Scheduling
- Audit Conduct – key areas of focus
- Reporting of audit results
- Good Laboratory Practice Audits
- Planning
- Scheduling
- Audit Conduct – key areas of focus
- Reporting of audit results
- Good Manufacturing Practices/Quality System Audits
- Planning
- Scheduling
- Audit Conduct – key areas of focus
- Reporting of audit results
Learning Objectives
This course is designed so that you will:
- Know what is involved with an effective internal and external quality audit, and how to plan for its successful implementation
- Understand the types of QA audits which are conducted, why they are necessary and the value they provide
- Learn how to prepare for conducting an audit, achieving closure and how to get the best out of your quality audit system
- Connect these audits with your corrective and preventive action (CAPA) programs
- Be able to "sell" management on implementing effective internal quality audits and supplier/contractor audits
