Alice Redmond – Vice President, Commissioning Agents, Inc.

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    • Alice Redmond – Vice President, Commissioning Agents, Inc.'s presentations

    Alice Redmond is an experienced Regulatory Compliance commissioning, qualification, and validation subject matter expert with 20+ years of experience in providing technical services to pharmaceutical and biotechnology industries. Member of the task team that authored ASTM E2500 and contributing author to ISPE guidance documents on implementing science and risk based qualification. Significant experience with project planning and coordination. Deep understanding of aseptic processing, oral solid dosage, powder inhaler, pen injector, packaging, labeling, and warehousing operations. Past experience and understanding of biotech, API, medical device operations. Understands FDA regulations, regulatory guidance documents, and ICH guidelines and applies knowledge to develop risk based approaches for several applications. Skilled risk assessment facilitator. Familiar with Lean principles and tools, Kaizen events, root cause analysis, visual workplace, Standardised work and process mapping.

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