David H. Artiss
Artiss & Associates Inc
President
David Artiss has been specializing in pharmaceutical processes and systems for many years and has been responsible for the engineering design and construction, auditing and qualification of hundreds of critical pharmaceutical process and utility systems, including those for Manufacturing Processes, Purified Water, Water For Injection, Pure Steam, HVAC, Compressed Air, Process Gas, Vacuum, CIP / SIP and Process Drainage.
He has been active in the establishment of Validation Master Plans and overseeing the implementation of Validation Programs for the Qualification of all phases of the Design, Site Acceptance Testing, Construction, Installation, Field Acceptance Testing, Commissioning, Operation and Performance of critical fluid handling systems.
He has been involved in auditing engineering procedures and practices for suitability to support critical pharmaceutical operations and implementing improvements.
• Engineering document and drawing control programs and procedures
• Calibration / metrology control programs and procedures
• Maintenance control programs and procedures
• Materials control programs and procedures
• Construction control programs and procedures
EDUCATION:
• Advanced degrees in Mechanical and Production Engineering
• Continuing education in many career related subjects
PROFESSIONAL ASSOCIATIONS:
• Active in the PDA, ISPE, IEST and other pharmaceutical professional associations as a director, member, presenter and committee member.
PUBLICATIONS AND PRESENTATIONS:
o Authored a chapter on PW, WFI and PS in the highly regarded “Qualification and Validation of Pharmaceutical Processes and Systems” by Leon Lachman PhD.
o Active as a lecturer at the Center for Professional Advancement
o Conducted numerous interactive and pragmatic training seminars on the following subjects for the FDA, ISPE, PDA and pharmaceutical companies:
• cGMP requirements and practical interpretation
• Pharmaceutical engineering concepts for non-engineers
• Engineering document and drawing control programs
• Stainless steel fabrication and equipment inspection procedures
• Sanitary design concepts and requirements
• Process and utility systems design, operation and maintenance
• Materials control programs from preshipment inspection through to construction completion
• Welding and weld quality assurance
• Cleaning and passivation techniques
• Practical Validation / Qualification programs (SAT, FAT, DQ, IQ, OQ, PQ)
He has been active in the establishment of Validation Master Plans and overseeing the implementation of Validation Programs for the Qualification of all phases of the Design, Site Acceptance Testing, Construction, Installation, Field Acceptance Testing, Commissioning, Operation and Performance of critical fluid handling systems.
He has been involved in auditing engineering procedures and practices for suitability to support critical pharmaceutical operations and implementing improvements.
• Engineering document and drawing control programs and procedures
• Calibration / metrology control programs and procedures
• Maintenance control programs and procedures
• Materials control programs and procedures
• Construction control programs and procedures
EDUCATION:
• Advanced degrees in Mechanical and Production Engineering
• Continuing education in many career related subjects
PROFESSIONAL ASSOCIATIONS:
• Active in the PDA, ISPE, IEST and other pharmaceutical professional associations as a director, member, presenter and committee member.
PUBLICATIONS AND PRESENTATIONS:
o Authored a chapter on PW, WFI and PS in the highly regarded “Qualification and Validation of Pharmaceutical Processes and Systems” by Leon Lachman PhD.
o Active as a lecturer at the Center for Professional Advancement
o Conducted numerous interactive and pragmatic training seminars on the following subjects for the FDA, ISPE, PDA and pharmaceutical companies:
• cGMP requirements and practical interpretation
• Pharmaceutical engineering concepts for non-engineers
• Engineering document and drawing control programs
• Stainless steel fabrication and equipment inspection procedures
• Sanitary design concepts and requirements
• Process and utility systems design, operation and maintenance
• Materials control programs from preshipment inspection through to construction completion
• Welding and weld quality assurance
• Cleaning and passivation techniques
• Practical Validation / Qualification programs (SAT, FAT, DQ, IQ, OQ, PQ)