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Audit Readiness in Pharma Starts with Strong Auditors In the pharmaceutical industry, auditing contractors, vendors, and suppliers is not optional. It is a core quality responsibility. Weak audits expose organizations to compliance risk, data integrity gaps, and avoidable regulatory findings. Strong audits protect product quality and patient safety.
This workshop is designed to strengthen auditing capability across the pharmaceutical and allied industries. It focuses on practical, real-world auditing skills needed to evaluate GMP compliance and Quality Systems across suppliers, contractors, and internal operations.
Participants will gain structured guidance on audit preparation, audit design, data integrity review, execution, reporting, and follow-up. The program also addresses the technical depth required to audit across different environments, including chemical APIs, biological APIs, and multiple dosage forms.
The goal is simple. Build confident auditors and support organizations in achieving consistent, controlled, stress-free audit readiness.
Who Should Attend This workshop is ideal for professionals who conduct supplier or internal audits on a regular basis. This includes Quality Assurance professionals, internal and external auditors, and individuals involved in evaluating third-party GMP compliance. It is also highly relevant for Qualified Persons seeking to strengthen their auditing expertise and regulatory confidence.
What the Workshop Covers Participants will receive practical training across the full audit lifecycle, including: - Auditing fundamentals and audit types
- Audit planning and preparation
- Conducting effective audits
- Interviewing and observation techniques
- Audit analysis tools
- Writing clear, defensible audit reports
- Audit follow-up and closure
Examples and hands-on exercises are integrated throughout the workshop to reinforce learning and real-world application.
Learning Outcomes By the end of this workshop, participants will be able to: - Understand auditor roles, responsibilities, and audit classifications
- Plan and structure audits aligned with regulatory and industry expectations
- Conduct effective audit meetings, interviews, and data reviews
- Document findings clearly and provide constructive, professional feedback
- Consolidate audit outcomes into strong reports and corrective action plans
- Support continuous improvement and management accountability
This workshop provides a structured, regulator-aligned approach to auditing that strengthens compliance and builds long-term audit confidence.
Be audit-ready. Be consistent. Be confident. |