1773 Kings Road, Vista, CA 92084-3640, USA
Tel 1-760-941-2040 or 1-800-698-2040, Fax 1-760-301-0308, e-mail: info@cce-us.com

Course Content:

The Why, Who, How, Where and When of Inspections

Audit Preparation for Auditors

• Definition of Audit Goals

• Agenda Development

• Collection of Information on Auditee

• Contacting Auditee

How to Conduct an Audit

• Entry Meeting

• Company Organization

• Review of Documents

  • MBR and supporting SOP’s

  • Policies and Plans

  • SOP’s supporting

    • Operations

    • Materials Handling

    • QA

    • QC

    • Manufacturing

    • Facility and Equipment Maintenance

  • Validation Records for

    • Analytical Methods

    • Facility

    • Utilities

    • Process Equipment

    • Manufacturing Process

    • Product Shipping

  • Vendor Qualification and History Records

  • Change Control

  • Document Control

  • Handling of Planned and Unplanned Deviations

  • Handling of Failed Batches

  • OOS Result Handling

  • Job Description and Training Records

• Facility Tour

  • Materials Receiving and Storage

  • Manufacturing Suites

  • Product Storage and Shipping

  • Utility Equipment and Routing

  • QC Laboratories

  • Operator Interviews

  • Review of Log Books and Equipment Readiness

  • Exit Interview / Form-483 Observations

Audit Preparation for Auditees

• Solid GMP Implementation

• Assignment of Responsibilities

• Internal Audits

• Mock Audits

• Auditing Etiquette for Auditees

• Training of Personnel

How to Receive an Audit

• Reception of Inspectors

• Presentation of Company

• Cooperation with Inspectors

• Clarification of Misunderstandings

• Proper Note Taking

Audit Follow-up

• Submission of Draft Audit Report

• Auditee’s Response to Draft Audit Report

• Responding to Form-483 Observations

• Establishment Inspection Report

• The Re-audit 

• Avoiding Regulatory Warning Letters

 









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