Auditing for Medical Device and Pharma Companies
This 2-day seminar is an essential guide on how to create and implement an efficient and effective internal audit program. Internal Audit is a required part of an effective quality system. More importantly, it is an incredibly powerful tool to identify areas of non-compliance. A well-designed audit program can be an effective tool in understanding, communicating, and reducing quality and compliance risk.
However, many companies conduct audits only because they are required to by regulation. Businesses often see internal audit as a non-value added activity leading to meaningless findings, bureaucracy, and cumbersome processes. And despite having an internal audit program, management is often surprised when they receive a 483, Warning Letter, or even a Consent Decree. A well-planned audit program can reduce these risks.
In this seminar, we will discuss:
How to develop and implement an efficient and effective audit program
Red-flags that your program is not effective
Risk Analysis techniques
Audit Program Structure
The auditing process – steps and tools
Documentation and communication
Linkages within your Quality System to ensure audits lead to effective solutions and lasting improvement
Using lecture, interactive discussion, and exercises, this seminar will provide tools and techniques for you to develop or improve your audit program. Students will come away with key concepts, practice in these concepts, and extensive course notes for future use and reference. This 2-day seminar will cover the following areas:
Using a structured program to identify areas of risk leading to an effective audit strategy.
How to develop a meaningful structure of audit, oversight, transparent communication, and escalation to management review.
How to ensure your audit staff is well trained to proactively identify, communicate, and escalate issues.
How a culture of quality and compliance can encourage clear and transparent communication of risk.
How to prioritize, resource, and implement corrective actions.
Techniques for monitoring and communicating risk and improvement over time.
How to identify residual risk.
Signs that your company culture is taking unnecessary compliance or quality risk.
How to ensure management gets valuable information from your audit program.
Tools for documenting audit observations and managing corrective and preventive actions.
Roles and responsibilities.
Day 01(8:30 AM - 4:30 PM)
Registration Process: 8:30 AM – 9:00 AM
Session Start Time: 9:00 AM
Quality Systems requirements
Types and goals of audits
Creating a program
Oversight, communication, monitoring, and escalation
Linkages in your Quality System
Metrics and monitoring
What the FDA can look at
Record keeping and documentation
Auditor qualifications and skills
Day 02(8:30 AM - 4:30 PM)
The auditing process
Focus on Supplier Auditing
Red Flags and Warning Signs