Process Validation Master Planning DMAIC FusionGENEO
Process validation is a risk management verification activity for medical device and pharma companies. DMAIC is a well established methodology for improving process reliability, improving businesses and solving problems. This presentation discussed a logical fusion of these approaches. It includes a description of the validation life cycle. The business case for good validation is illustrated graphically. Contact us at ARVExcellence.com if you would like a copy.
ARV Excellence is a training and consulting firm based in Galway, Ireland with specialities in medical devices, and drug device combination product processes and process related problem solving
CPSC experts and representatives of a law firm used this presentation to discuss testing and certification issues, component parts testing, and certificates of conformity.
Process Validation Master Planning DMAIC FusionGENEO
Process validation is a risk management verification activity for medical device and pharma companies. DMAIC is a well established methodology for improving process reliability, improving businesses and solving problems. This presentation discussed a logical fusion of these approaches. It includes a description of the validation life cycle. The business case for good validation is illustrated graphically. Contact us at ARVExcellence.com if you would like a copy.
ARV Excellence is a training and consulting firm based in Galway, Ireland with specialities in medical devices, and drug device combination product processes and process related problem solving
CPSC experts and representatives of a law firm used this presentation to discuss testing and certification issues, component parts testing, and certificates of conformity.
Handling of Customer Complaint_Dr.A.AmsavelDr. Amsavel A
Reference Guideline
Definitions
GMP Requirement: 21 CFR § 211.198 and ICH Q7
Procedure for Handling of Complaints
Complaint Investigation
Remedial action and CAPA
Report preparation
Response to customer
Verification of CAPA effectiveness
Review of Complaints
This presentation will enable you to understand the requirements needed to make any forensic or analytical laboratory accredited and at par with other accredited laboratories worldwide. QMS is a mandatory and integral part of any organization to assure good quality to customers or consumers.
Process Validation Presentation from BioTechLogicPeter Dellva
Exploring Manufacturing Process Validation - BioTechLogic, Inc. is a biopharmaceutical manufacturing and CMC consulting firm with strategic and practical/hands-on experience that helps clients bring their products to market quickly and successfully by augmenting and optimizing an organization’s technical, manufacturing, analytical, and regulatory resources.
Our technical expertise resides in a wide range of biological and oligonucleotide products including recombinant proteins, vaccines and blood products. Through the combined expertise and knowledge of our staff, we have developed proven methodologies and approaches for providing reliable and dependable services in the following areas:
Process Development and Quality by Design (QbD) including:
Design of Experiments (DOE)
Development Reports
Critical Process Parameter Evaluation
Technology Implementation, Transfer and Scale-up
On-site third party contract manufacturing support
BioAnalytical Services
Process Validation
Biotechnology Project Management
Quality Assurance
Regulatory Submissions
PAI Inspection Readiness (FDA Pre-Approval Inspection Readiness)
Dti pab requirements for accreditation bodiesNcmf Halal
Presentation made byOIC Cirila Boton of PAB-DTI, lectured by Uz. Abdulhadi T. Daguit of the NCMF Halal Program Office on Feb.2, 2015 @NCMF Social Hall, Central Office.
DTI- Philippine Accreditation Bureau (PAB) ISO/IEC Guide 65:1996Ncmf Halal
Presentation made by OIC Cirila Boton of PAO- DTI, lectured by Uz. Abdulhadi T. Daguit of the NCMF Halal Program Office on Jan.12,2015@NCMF Social Hall, Central Office.
Deliberate Practice, New Learning Styles (2015)Peter Kofler
Presentation about Deliberate Practice at the Austrian Testing Board "Expertentreff". This covers the Software Crisis, Developing Quality Software Developers and the mechanisms of Code Katas, Coding Dojos and Code Retreats.
Handling of Customer Complaint_Dr.A.AmsavelDr. Amsavel A
Reference Guideline
Definitions
GMP Requirement: 21 CFR § 211.198 and ICH Q7
Procedure for Handling of Complaints
Complaint Investigation
Remedial action and CAPA
Report preparation
Response to customer
Verification of CAPA effectiveness
Review of Complaints
This presentation will enable you to understand the requirements needed to make any forensic or analytical laboratory accredited and at par with other accredited laboratories worldwide. QMS is a mandatory and integral part of any organization to assure good quality to customers or consumers.
Process Validation Presentation from BioTechLogicPeter Dellva
Exploring Manufacturing Process Validation - BioTechLogic, Inc. is a biopharmaceutical manufacturing and CMC consulting firm with strategic and practical/hands-on experience that helps clients bring their products to market quickly and successfully by augmenting and optimizing an organization’s technical, manufacturing, analytical, and regulatory resources.
Our technical expertise resides in a wide range of biological and oligonucleotide products including recombinant proteins, vaccines and blood products. Through the combined expertise and knowledge of our staff, we have developed proven methodologies and approaches for providing reliable and dependable services in the following areas:
Process Development and Quality by Design (QbD) including:
Design of Experiments (DOE)
Development Reports
Critical Process Parameter Evaluation
Technology Implementation, Transfer and Scale-up
On-site third party contract manufacturing support
BioAnalytical Services
Process Validation
Biotechnology Project Management
Quality Assurance
Regulatory Submissions
PAI Inspection Readiness (FDA Pre-Approval Inspection Readiness)
Dti pab requirements for accreditation bodiesNcmf Halal
Presentation made byOIC Cirila Boton of PAB-DTI, lectured by Uz. Abdulhadi T. Daguit of the NCMF Halal Program Office on Feb.2, 2015 @NCMF Social Hall, Central Office.
DTI- Philippine Accreditation Bureau (PAB) ISO/IEC Guide 65:1996Ncmf Halal
Presentation made by OIC Cirila Boton of PAO- DTI, lectured by Uz. Abdulhadi T. Daguit of the NCMF Halal Program Office on Jan.12,2015@NCMF Social Hall, Central Office.
Deliberate Practice, New Learning Styles (2015)Peter Kofler
Presentation about Deliberate Practice at the Austrian Testing Board "Expertentreff". This covers the Software Crisis, Developing Quality Software Developers and the mechanisms of Code Katas, Coding Dojos and Code Retreats.
Pharmaceutical Validation: Role in Phamaceutical Industrykaunainfathema1
This is a brief presentation on various concepts under Pharamaceutical Validation including its importance, scope, history, authorities, types of validation, VMP; along with the ICH and WHO Guidelines to be followed for Calibration of Equipments.
NON DESTRUCTIVE TESTING EVALUATION: AUDITOR NDT TRAINING.pptRaistlin11
NON DESTRUCTIVE TESTING EVALUATION
Auditor NDT Training
The purpose of this training is to give the auditor a familiarity of the quality control and quality assurance systems associated with Nondestructive testing.
Agenda:
Training and Certification.
Audit/Evaluation & Surveillance.
Liquid Penetrant Inspection.
Magnetic Particle Inspection.
Radiography Inspection.
Ultrasonic Inspection.
Eddy Current Inspection
Overview:
1) Documentation- written procedures, processes specifications and/or methods used by the vendor in performance and controls of NDT activities.
2) Organization- relationship of NDT organization to management.
3) Environment- the general physical condition of the facility, e.g.,housekeeping, storage, safety, consumable management, equipment.
4) Calibration- process by which an item is checked to a standard.
5) Training- methods used and records maintained to train and retrain NDT personnel
El 12 de mayo de 2017 celebramos en la Fundación Ramó Areces una jornada con IS Global y Unitaid sobre enfermedades transmitidas por vectores, como la malaria, entre otras.
Home Care Services are designed to meet Service Users’ needs and should always ensure the Health and Safety of both the Service User and staff members involved. This requires staff to behave in a professional manner at all times and ensure that the Service User is kept informed of matters which may affect them.
These slides are meant for awareness training for the institutions which are seeking accreditation in ISO 15189. Although the current standard is the 4th version, some information in these slides might be useful in assisting the laboratory in preparing for the accreditation since the newest version is less prescriptive.
PetroSync - IWCF Certification Drilling Well Control Level 3 & 4PetroSync
This course is designed for people in critical well control positions on drilling installation as well as onshore roles. The candidates will complete an IWCF accredited training course, taught according to IWCF syllabus, in order to prepare them for assessment.
PetroSync - IWCF Certification Drilling Well Control Level 2PetroSync
This course is designed for people in critical well control positions on drilling installation as well as onshore roles. The candidates will complete an IWCF accredited training course, taught according to IWCF syllabus, in order to prepare them for assessment.
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