Global Certificate in PharmaTech Auditing Techniques
-- ViewingNowThe Global Certificate in PharmaTech Auditing Techniques is a comprehensive course designed to meet the growing industry demand for professionals with expertise in pharmaceutical technology auditing. This course emphasizes the importance of auditing techniques in ensuring compliance with regulatory standards, thereby enhancing the safety and efficacy of pharmaceutical products.
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โข PharmaTech Auditing Fundamentals: Introduction to PharmaTech auditing, types of audits, and the importance of auditing in the pharmaceutical industry.
โข Regulatory Compliance: Overview of global pharmaceutical regulations, compliance requirements, and enforcement mechanisms.
โข Quality Management Systems (QMS): Understanding the principles and implementation of QMS, including ISO 9001 and cGMP.
โข Risk Management: Identifying, assessing, and mitigating risks in PharmaTech operations, including HACCP and FMEA.
โข Good Documentation Practices (GDP): Implementing and maintaining GDP, including document control and record management.
โข Audit Planning and Preparation: Planning and preparing for PharmaTech audits, including scope, schedule, and checklists.
โข Audit Execution and Reporting: Executing PharmaTech audits, including data gathering, interviewing, and reporting findings.
โข Audit Follow-up and Corrective Action: Follow-up on audit findings, including root cause analysis, corrective action planning, and verification.
โข Continuous Improvement: Implementing continuous improvement programs, including Lean, Six Sigma, and Kaizen.
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