Auditing Deviations, Product Complaints, and CAPA Systems
Among the essential elements of a well-established Quality Management System (QMS), deviation handling plays a key role in assuring quality in products and by contributing to continuous improvement. Manufacturers are expected to “establish processes and define appropriate controls for measurement and analysis to identify nonconformities and potential nonconformities, defining when and how corrections, corrective actions, or preventive actions should be undertaken. These actions should be commensurate with the significance or risk of the nonconformity or potential nonconformity. GMPs have evolved as a consequence and of the inherent risks to the product during manufacturing operations in order to prevent significant deviations. More recently, Quality Risk Management (QRM) has been proposed as a strategy to manage risk in a systematic and documented manner, and has become a requirement of modern GMPs as recommended by international standards like WHO or ICH.
- Understand the main objectives for conducting laboratory audit and inspections
- Discuss how to prepare for conducting an audit
- Learn how to assembling an audit team
- Identify the areas of deficiencies
- Review the do’s and don’ts during the audit
- Prepare the audit report
- Implementation of a company wide data integrity program
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Auditing Deviations, Product Complaints, and CAPA Systems Conference Speakers
Recommended Sessions
- Pharmaceutical Audit
- Auditing Deviations, Product Complaints, and CAPA Systems
- Best Industry Practices
- Biologics & Biosimilars
- Clinical Affairs & Regulatory Strategies
- Contract and Sterile/Aseptic Manufacturing
- Current GMP Guidelines (cGMP) & GxP in Pharmaceuticals
- Current Regulations and Quality Standards
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- Intellectual Property Rights
- Medical Device & Combination Products Regulations
- Penalties for Regulatory Non-compliance
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- Regulatory Affairs
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- Regulatory Requirements for Pharmaceuticals
- Softwares in GMP and GCP
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- Systems Pharmacology and Drug Modeling - Euro Pharmacology 2025 (France)
- Target Identification and Validation - Euro MedChem and CADD 2025 (France)
- Targeted Drug Delivery and Nanomedicine in Infectious Diseases - Euro Antibiotics 2025 (Netherlands)
- Targeted Drug Delivery and Precision Medicine - Drug Delivery-2025 (France)
- Targeted Therapies - Personalizedmedicine-2025 (Switzerland)
- Technology in Pharma Sciences - MedTech-2025 (Switzerland)
- Telemedicine - Personalizedmedicine-2025 (Switzerland)
- The Future of Pharma R&D - Future Pharma 2025 (Netherlands)
- The Role of CROs in Clinical Trial Execution - Clinical Trials-2026 (UK)
- Toxicological Impacts of Air and Water Pollution - Euro Pharmacology 2025 (France)
- Toxicology and Safety Pharmacology - Pharmacology-2025 (Spain)
- Toxicology: Mechanisms and Risk Assessment - Euro Pharmacology 2025 (France)
- Transdermal and Intradermal Delivery Systems - Drug Delivery-2025 (Netherlands)
- Translational Research - Personalizedmedicine-2025 (Switzerland)
- Trending: Digital Health and Telemedicine for Rare Care - ORPHAN DRUGS 2025 (France)
- Types of Formulations - Formulations 2025 (France)
- Vaccine Delivery Technologies - Drug Delivery-2025 (Netherlands)
- Vaccine Development Against Bacterial Pathogens - Euro Antibiotics 2025 (Netherlands)
- Vaccine Drug Delivery Systems - PHARMACEUTICA 2025 (Germany)
- Vaccines & Immunotherapy - Pharma Expo-2026 (Thailand)
- Veterinary Pharmacology - Pharmacology-2025 (Spain)
- Women in Rare Disease Leadership and Science - ORPHAN DRUGS 2025 (France)