Auditing: Internal and External
Home Up


We also recommend: [Procedure Writing for Greater Process Control] [Faster Product Release Through Efficient Batch Record Review]


Auditing: Internal and External Customers and Suppliers




To apply an auditing model that applies to a wide-variety of situations.



1.   State the regulatory requirements for audits.

2.   Identify common reactions to the audit process.

3.   Manage adverse reactions to audits.

4.   Plan an efficient and thorough audit.

5.   Apply the Quality System inspection approach for audit planning.

6.   Review relevant regulations applicable to the audit area.

7.   Gather evidence of compliance/noncompliance.

8.   Report results to affect change and build relationships.

9.   Manage the corrective action and preventive action process


About the Class

  1. In-house projects will be used to demonstrate and practice the skills and principles of this class.

  2. The optional final exam is approximately 25 questions.

  3. Each student receives a student guide containing a representation of the program's slides and graphics with space provided for note taking.

  4. This class can accommodate up to 25 people.

  5. Duration: 8 hours as a minimum. Depending on the project selected, this class may take several days.




1.   CGMP Requirements

2.   Definitions


Managing Audits         

1.   Auditor's role

2.   Auditee's concerns

3.   Auditor concerns

4.   Barriers to an effective audit

5.   Audit master plan

6.   Audit frequency

7.   Communication and the audit


Pre-audit Questionnaire

1.   Purpose

2.   Designing

3.   Barrier to use

4.   Overcoming barriers

5.   Activity: Writing A Pre-audit Questionnaire


Audit Focus    

1.   Overview of the audit

2.   Traditional approach

3.   Quality systems approach

4.   Problem-based audit

5.   Process-based audit

6.   Complaint-based approach

7.   Quality system-based approach

8.   Single issue-based approach

9.   Flow charting the process

10.  Activity: Flow Charting Your Audit


Gathering Evidence     

1.   Sources

2.   Benchmarks

3.   Questions

4.   Probing

5.   Activity: Data Gathering Plan



1.   Rating system options

2.   Ratings versus narratives

3.   Activity: Creating An Evaluation System


Auditing Report

1.   Content

2.   Guidance


Wrap Up



Call to learn about how we can customize this outline for any of your site's CGMP training needs. Standard outlines may change without notice. To speak with the lead instructor for this class please call Allan Dewes at 415.948.5220.


For a prompt reply to requests and questions:  415.948.5220 |    |   Fax: 954.566.5225

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