InTouch
When the ISPE Baseline Guide Vol. 5, Commissioning & Qualification, 2 ed. was published in 2019, most of the attention was focused on the incorporation of quality risk...
Chip Bennett
Project Farma
Sr. Director, Manufacturing Technical Solutions
· Chip Bennett is a PMI® Certified Project Management Professional (PMP), a recognized industry expert, speaker, and published author, and a consultant with 25 years of experience in the pharmaceutical and regulated non-pharmaceutical industries and with expertise in risk-based C&Q, aseptic manufacturing, cleaning validation, quality systems, and owner project management. Chip is responsible for developing and implementing Quality Risk Management (QRM) based Commissioning and Qualification programs and projects, with a particular focus on assessing and training clients regarding development, implementation, and transition to risk-based approaches.
· Chip has broad-based experience with validation of facilities, utilities, and equipment; computer system validation; process validation; and cleaning validation. This experience includes manufacturing, packaging, and laboratory facilities; critical utilities; aseptic processes and sterile filling; oral solid dose manufacturing; packaging systems; environmental chambers; and warehouses. As a quality consultant, Chip has experience with quality systems, quality risk management, risk assessment, root cause analysis, change control, CAPA, and failure investigation. Chip has managed facility qualification and cleaning validation projects for clients in the medical device and regulated non-pharmaceutical industries.
· Chip is a sought-after speaker and author in the industry, the lead author of the ISPE Good Practice Guide: Good Engineering Practice, 2nd Ed. (2021), and an active author, presenter, and contributor in the ISPE Validation 4.0 Special Interest Group as part of the ISPE Pharma 4.0 working group.
· Chip has conducted training in the United States, Europe, and Asia, and is an ISPE Qualified Instructor for:
· G01 Fundamentals of GMP
· T40 QRM-Based Commissioning and Qualification
· T75 Good Engineering Practice
· Chip has broad-based experience with validation of facilities, utilities, and equipment; computer system validation; process validation; and cleaning validation. This experience includes manufacturing, packaging, and laboratory facilities; critical utilities; aseptic processes and sterile filling; oral solid dose manufacturing; packaging systems; environmental chambers; and warehouses. As a quality consultant, Chip has experience with quality systems, quality risk management, risk assessment, root cause analysis, change control, CAPA, and failure investigation. Chip has managed facility qualification and cleaning validation projects for clients in the medical device and regulated non-pharmaceutical industries.
· Chip is a sought-after speaker and author in the industry, the lead author of the ISPE Good Practice Guide: Good Engineering Practice, 2nd Ed. (2021), and an active author, presenter, and contributor in the ISPE Validation 4.0 Special Interest Group as part of the ISPE Pharma 4.0 working group.
· Chip has conducted training in the United States, Europe, and Asia, and is an ISPE Qualified Instructor for:
· G01 Fundamentals of GMP
· T40 QRM-Based Commissioning and Qualification
· T75 Good Engineering Practice
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