Regulatory Essentials - At a Glance
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Ann Spjut has extensive experience in laboratory management and regulatory compliance. She has collaborated with executive leadership to develop quality control manuals and SOPs, implemented process improvements that increased efficiency and reduced costs, and overseen personnel, facilities, equipment, customer satisfaction and non-conforming event management. Some of her accomplishments include developing policies and procedures, separating lab processing from data entry to increase output while reducing costs, and creating comprehensive inventory and document control systems.
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Quality management Policy is a set of the rule that is helpful to produce quality product at manufacturing site. 1. Background
The following document provides general considerations with respect to
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2. Responsibilities.
QA, QC, QMS and audit are the responsibility of the director of the
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3. Quality Assurance (QA)
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quality needed for the project. The QA systems in place will be covered
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Title – Each SOP should be given a unique name which captures
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Number – Each SOP should be given a unique number that can
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Date – The date the procedure is to be reviewed as well as the
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Equipment – A list of the equipment needed to perform the
procedure.
Supplies – All materials and supplies should be recorded.
Step-by-Step Guidance – The procedure should be written in
specific detail to ensure that the procedure can be repeated in a
reproducible fashion to include the order of steps that should be
followed, the times allowed for each step (as needed) and the
temperatures at which the steps are performed.
All SOPs before implementation or after revision will be approved by the
management committee before implementation. Previous versions of all
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QA & QM procedures
Document Reference:
Page 3 of 3
4. QUALITY MANAGEMENT SYSTEM (QMS)
The QMS describes the biorepository’s commitment to quality and
approaches for ensuring that the requirements of the QA program are
met.
Security
The facility is in a secure, locked area with limited access.
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date & time and reason for entry.
Training
Personnel should be trained in all procedures and successful
completion of such training is documented with evidence of updates
as required, on a periodic basis.
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"How to Create a Real Competitive Environment through Effective Integration of QA/QC"
Manager 2017 TN
Jennifer Meade is seeking a new position. She has over 20 years of experience in operations management, lean six sigma, root cause analysis, and supply chain. Her background includes positions in production supervision, customer service management, field auditing, and warehouse coordination. She has a proven track record of delivering cost savings and process improvements.
Stephen Keokhanthachone Resume Jan. 2017
The document is a resume for Stephen S. Keokhanthachone seeking a position utilizing his background in documentation specialization, quality assurance, and process engineering. It summarizes his experience developing and maintaining documentation systems for medical device production in compliance with quality standards. His resume lists responsibilities such as managing document control, ensuring proper documentation practices, training personnel, and assisting with audits from his roles at various medical technology companies.
PSM RM - Understand hazards and risk
Organizations that understand hazards and risk are better able to allocate limited resources in the most effective manner. Industry experience has demonstrated that businesses using hazard and risk information to plan, develop, and deploy stable, lower-risk operations are much more likely to enjoy long term success.
CV_MLO_EN_V0002_RG3ML1
This document provides information on Mercedes Lopez's work experience and qualifications. She has over 15 years of experience in regulatory affairs, quality assurance, and document management. Her previous roles include positions at Imprimis Pharmaceuticals, Epic Sciences, Cosmederm Biosciences, ZimmerDental, Glanbia Nutritionals, Expert Chemical Analysis, Agouron Pharmaceuticals, Corvas International, and Canji Inc. She has expertise in areas such as computer system validation, quality management systems, 21 CFR regulations, change control management, inspection readiness, and ISO 13485. Mercedes is proficient in configuring and implementing document management and quality management systems.
Similar to Regulatory Essentials - At a Glance (20)
Smart Pharmaceutical Consulting - Lean Manufacturing of Pharmaceuticals
Smart Pharmaceutical Consulting - Lean Manufacturing of Pharmaceuticals
Regulatory Essentials - At a Glance
- 1. ANN SPJUT REGULATORY ESSENTIALS – AT A GLANCE 1. ORGANIZATIONAL LEADERSHIP - Collaborated with the CEO and executive leadership team to develop and implement quality control manual and SOPs that governed the entire company. 2. PROCESS IMPROVEMENT - Developed 73 minor technology improvements to highly manual work flow processes in CRM and LIS systems, resulting in reduction of 4 FTE, a cost saving of ~$220k/year. 3. INFORMATION MANAGEMENT - Managed software development lifecycle / CAPA processes. Led integration of internal help desk with external client-facing IT team, saving $100k/year. 4. PERSONNEL MANAGEMENT - Supervised over 200 employees under 9 (direct report) managers. Oversaw matrixed annual employee reviews - from transcriptionists to PhDs. 5. FACILITIES & SAFETY – Participated in 2 OSHA inspections regarding specimen handling and safety management. Reported issues, confirmed absence of wrongdoing, and documented decontamination processes. 6. DOCUMENTS & RECORDS – Wrote and trained lab staff on 170 policies & procedures with corresponding competency assessments. Developed and implanted a strong document control system maintain all document records. 7. PROCESS MANAGEMENT - Separated accessioning (data entry) from lab processing to expedite lab work. Increased specimen output from 100/day to 170/day (with goal of 200/day by Q4 2017), a cost savings of $75k/year. 8. EQUIPMENT MANAGEMENT - With 15+ years of lab management experience and diverse equipment proficiency, adept at instrumentation verification, documentation, comparison, tracking, repair, and troubleshooting. 9. CUSTOMER SATISFACTION - Assembled user satisfaction survey regarding implementation of expanded panel for efficacy. 83 of 100 respondents (clinicians) confirmed ability to more appropriately treat patients as result. 10. MATERIAL MANAGEMENT - Created comprehensive inventory control system –from pre to post- analytical stages. Standardized monthly spend, preventing dwindled supplies and expedited 3rd party shipping fees. 11. MANAGEMENTOF NON-CONFORMING EVENTS - Documented root cause analysis and corrective action plans (CAPA) for errors/accidents: averaging 2-3 events/day in the laboratory; 3-4 events/month with IT software development (following deployment after smoke testing/peer review).