Steyer Consulting Engineering Resources

Steyer Consulting Engineering Resources provides a broad range of Engineering Services: from Aseptic Process Development and Process Optimization through Statistical Quality Control, Design Of Experiments, & Measurement System Analysis, to Project Engineering: Designing Large Capital Project including Aseptic cGMP Facilities, Aseptic cGMP Processes... , cGMP Laboratories, to cGMP Warehouse, through Commissioning Facilities, Equipment, & Processes, and Validation of: Aseptic Processes, Aseptic Equipment, Aseptic Facilities, Cleaning, Sterilization, and Depyrogenation. Steyer Consulting also specializes in: Failure Mode and Effects Analysis, Hazard Analysis and Critical Control Point Analysis, Statistical Quality Control Analysis, Measurement System Analysis (Gauge R&R), Analytical Analysis, and Design of Experiments; Solid working knowledge of: DMAIC/DFSS, Lean techniques and methodologies. Steyer Consulting is Accomplished at writing: Standard Operating Procedures (SOP), Manufacturing Operation Procedures (MOPs), Work Instructions, Sequence of Operations (SOO), User Requirement Specification (URS), Batch Production Documents (BPD), Equipment Specifications, Calibration Limits, and Procedures for pharmaceutical and/or medical device processes and facilities. Steyer Consulting Engineering Resources is Experienced and intimately familiar with: Title 21 CFR Parts 11, 58, 210, 211, 820, & 1301.72. ASTM E2500, EU Directive 2003/94/EC, EudraLex - Volume 4, HTM2010, MHRA 2007, ICH Guidelines Q7, through Q11, and ISO 13485 & 14971, Japanese MHLW Ministerial Ordinances, ANSI/NCSL Z540, and NCSL RP1, RP12, & RP18.Read More