ISO 22442 Lead Auditor

ISO 14001:2026 Environmental management systems – Requirements with guidance for use. Requirements, application, and auditing.

21 CFR Part 210 Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General

21 CFR Part 1271 Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)

ISO 13485:2016 – Medical Devices — Quality Management Systems — Requirements for Regulatory Purposes

ISO 19011:2016 Guidelines for Auditing Management Systems

21 CFR Part 211 Current Good Manufacturing Practice for Finished Pharmaceuticals

21 CFR Part 11 Electronic Records; Electronic Signatures

Using and Interpreting Control Charts for Continuous Process Monitoring

Fundamentals of Sampling Plans

ISO 9001:2026 – Lead Auditor

ISO 14001:2026 – Lead Auditor