Elements of Supplier and Internal Quality Audits
Regulatory authorities are increasingly expecting on-going, competent assessments of internally and externally sourced processes and materials. This course provides foundational information on regulatory requirements and expectations for audits as well as the different types of audits and their purposes. Additional information includes how to plan, conduct, and report audits as well as the investigatory and assessment tools used in audits.
Audience
Course material is appropriate for personnel new to auditing, experienced auditors that are assuming lead auditor responsibility, and senior management responsible for resourcing audit efforts and assessing the information obtained from those audits.
Topics Include
This 1 day 8 hour course covers the following topics:
- Three audit classification: Qualification, Surveillance and Special (For-Cause) Audits
- Regulatory Requirements and Expectations
- Food, Drug and Cosmetics Act
- 21 CFR Regulations
- Auditor Skills and Competencies
- Auditor Code of Conduct
- Audit Process Planning through Finalization
- Auditing Tools and Statistical Aids
- Audit Execution and Elements of Final Report
Learning Objectives
Upon successful completion participants will be able to:
- Provide an overview of general audit elements and principles
- Understand the basic process for planning, executing and closing an audit
- Define auditor skills and competencies
- Identify regulatory requirements and expectations applicable to audits
College Options
Request this Course
Level: Beginner
Lecture HoursLab or Activity HoursTotal
Delivery Options
Face-to-Face
Delivered in a classroom or lab setting.
Live Instructor Led
Delivered online with a Live Instructor teaching the course at a scheduled date and time.
Related
Course
Participants will learn the importance and benefits of having and completing Batch Production... more
Participants will learn the importance and benefits of having and completing Batch Production... more
Course
Technical writing is an important part of the life science industry, but only if the reader... more
Technical writing is an important part of the life science industry, but only if the reader... more
Course
Aseptic processing is utilized to prevent contamination and manufacture sterile products to ensure... more
Aseptic processing is utilized to prevent contamination and manufacture sterile products to ensure... more
Course
Students will learn how to write using the three most commonly needed skills in any type of... more
Students will learn how to write using the three most commonly needed skills in any type of... more
- 1 of 7
- >