Systems design, development and implementation, auditing and process improvement

By: Rudolph-shortt Consultancy  11-11-2011
Keywords: Food Safety, Medical Device

» Auditing & Training – – ISO9001, ISO17025, ISO22000, cGMP, ISO13485, GLP and GMP in
packaging, toiletries, pharmaceuticals, nutriceuticals, textiles, packing, manufacturing and the food
industry » Continuous Improvements Strategies – process mapping, risk assessment (SHEQ) and operations
realignment – Kaizen, APQP, 5S and Six Sigma» Systems development and improvements: Pharmaceutical GMP ISO13485 medical device ,
Environmental ISO14000, food safety management HACCP ISO22000 & Safety management for
OSHAct compliance system development and implementation» Productivity improvements by means of improvement identification and translation of the physical
business process, using a systemized approach, to provide clear process direction and management
control through the use of process mapping to develop and implementing improvement interventions.» Quality Assurance through ISO9001, PIC cGPM & HACCP development and Implementation with GMP
(Good Manufacturing Practice) installation with validation and verification activities. » APQP: Advanced Product Quality Planning (Verification and validation of process & product)» Kaizen: Process Improvement through IOP analysis and solution achievement with waste elimination
and value added process design realising cost improvements and continuous improvement» Regulatory: GMP compliance for pharmaceuticals and medical devices. Medical aid re-imbursement
motivations and submissions» Quality Control: Appropriate and effective process quality inspection and GLP
(Good Laboratory Practice) installation» Systems evaluations and alignment:        ° People – organizational structures and development strategies        ° Equipment – Total planned maintenance, calibration and validation        ° Premises – Factory layout, construction (clean room and controlled environments)        ° Infrastructure – Good manufacturing practices, ISO9001, ISO22000 (PRPs), ISO13485
(Risk assessment ISO14971), ISO14000 (Environment) & ISO18000 (Safety)/ OSH Act,         ° Measurement – Sampling and statistical techniques and testing methodology        ° Product – New product design and development, medicine registration and regulatory
affairs        ° Methods – 5S housekeeping, 6 Sigma value stream analysis and improvement, Process


Keywords: Food Safety, Medical Device

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