NABL specifies the general requirements for the competence to carry out tests and calibrations, including sampling. It covers testing and calibration performed using standard methods, non-standard methods, and laboratory-developed methods.
Benefits of Accreditation:
Potential increase in business due to enhanced customer confidence and satisfaction.
Savings in terms of time and money due to reduction or elimination of the need for re-testing .
Better control of laboratory operations and feedback to laboratories as to whether they have sound Quality Assurance System and are technically competent.
The PPT explain about the NABL and accreditation process according to the ISO 17025. And how you will get benefited with the NABL/ISO 17025 accreditation for your Lab.
The PPT explain about the NABL and accreditation process according to the ISO 17025. And how you will get benefited with the NABL/ISO 17025 accreditation for your Lab.
QUALIFICATION OF UV-VISIBLE SPECTROPHOTOMETER, FTIR, DSC, HPLCAnupriyaNR
Analytical method qualification consists of a simplified evaluation of a subset of validation characteristics with a goal to demonstrate that an analytical method is scientifically sound and suitable for its intended use. In contrast to validation, analytical method qualification is performed without predefined acceptability criteria. Qualification may be performed as a prerequisite to method validation, or when an assay for product knowledge has not yet been established as a test for a critical product quality attribute. Qualification of equipment is pre-requisite for validation of the process in which the equipment is being used. Many types of equipment have measuring devices on them. Calibration of measuring devices is a part of qualification. Calibration of measuring devices is important, as the data is often collected through them. If the data collected is not from measuring devices that have been calibrated, the data cannot be relied upon. Thus the whole validation exercise can be questioned.
PHARMACEUTICAL QUALITY ASSURANCE SIXTH SEMSTER B PHARM
Introduction, definition and general principles of calibration, qualification
and validation, importance and scope of validation, types of validation, validation master plan. Calibration of pH meter, Qualification of UV-Visible spectrophotometer, General principles of Analytical
method Validation.
Introduction, Regulatory requirements for validation, Role of FDA, Code of Federal regulation, Validation life cycle, Significance of validation, Types of validation, Process valiadation, Phases of process validation, Process capability design, Process Qualification, Validation maintainance phase
Types of Process validation, Examples
The National accreditation Board for Testing and Calibration laboratories (NABL) is an independent organization operating under the supervision of the Department of Science and Technology, Government of India. Its primary objective is to provide certification to clinical labs in India for their testing and calibration activities.
QUALIFICATION OF UV-VISIBLE SPECTROPHOTOMETER, FTIR, DSC, HPLCAnupriyaNR
Analytical method qualification consists of a simplified evaluation of a subset of validation characteristics with a goal to demonstrate that an analytical method is scientifically sound and suitable for its intended use. In contrast to validation, analytical method qualification is performed without predefined acceptability criteria. Qualification may be performed as a prerequisite to method validation, or when an assay for product knowledge has not yet been established as a test for a critical product quality attribute. Qualification of equipment is pre-requisite for validation of the process in which the equipment is being used. Many types of equipment have measuring devices on them. Calibration of measuring devices is a part of qualification. Calibration of measuring devices is important, as the data is often collected through them. If the data collected is not from measuring devices that have been calibrated, the data cannot be relied upon. Thus the whole validation exercise can be questioned.
PHARMACEUTICAL QUALITY ASSURANCE SIXTH SEMSTER B PHARM
Introduction, definition and general principles of calibration, qualification
and validation, importance and scope of validation, types of validation, validation master plan. Calibration of pH meter, Qualification of UV-Visible spectrophotometer, General principles of Analytical
method Validation.
Introduction, Regulatory requirements for validation, Role of FDA, Code of Federal regulation, Validation life cycle, Significance of validation, Types of validation, Process valiadation, Phases of process validation, Process capability design, Process Qualification, Validation maintainance phase
Types of Process validation, Examples
The National accreditation Board for Testing and Calibration laboratories (NABL) is an independent organization operating under the supervision of the Department of Science and Technology, Government of India. Its primary objective is to provide certification to clinical labs in India for their testing and calibration activities.
What is NABL ?
The National Accreditation Board for Testing and Calibration Laboratories (NABL) is an autonomous body under the guidance of the Dept. Of Science & Technology, Govt. of India.
iso 9001, iso 14001, ohsas 18001, iso 22000, haccp, iso 17025, iso 17025 nabl, nabl certification, iso 17020, iso 9001 certificate, iso 14001 certificate, iso 22000 certification
“Function of a health system concerned with the accumulation, mobilization and allocation of money to cover the health needs of the people, individually and collectively, in the health system.” (WHO)
Revenue collection :
Taxation-most equitable system of financing
Health insurance contributions
User pays (out of pocket, no reimbursement)
Donor funding/Grants
International converget healthcare systemSAM VIVEK
1. CONVERGENCE AMONG MEDICAL PROFESSIONALS, EDUCATION, AND SCIENCE
2. CONVERGENCE AMONG HOSPITALS AND INSURERS
3. CONVERGENCE AMONG MEDICAL PRODUCTS AND TECHNOLOGIES
4. PRIVATIZATION, COMMERCIALIZATION, AND AMERICAN MEDICINE
Organized efforts and procedures for identifying workplace hazards and reducing accidents and exposure to harmful situations and substances. It also includes training of personnel in accident prevention, accident response, emergency preparedness, and use of protective clothing and equipment.
COMMON ETIQUETTE IN WRITTEN COMMUNICATION
Focus on format
Structuring of the content
Ensuring connectivity
Tempering the content as per the level of formality
Avoid short form
Importance of grammar, spelling and punctuation
Importance of creativity
Avoiding excessive use of jargon
Awareness of the audience/medium
Corruption is a type of strategic action.
Two or more people undertake an exchange relation by way of a successful transfer of money or power which sidesteps legality or morality to regulate the relation.
“Processes by which goods, services, capital, people, information, and ideas flow across national borders.”
The process of integration of economic, financial, cultural and political systems across the world.
Leading the Way in Nephrology: Dr. David Greene's Work with Stem Cells for Ki...Dr. David Greene Arizona
As we watch Dr. Greene's continued efforts and research in Arizona, it's clear that stem cell therapy holds a promising key to unlocking new doors in the treatment of kidney disease. With each study and trial, we step closer to a world where kidney disease is no longer a life sentence but a treatable condition, thanks to pioneers like Dr. David Greene.
CRISPR-Cas9, a revolutionary gene-editing tool, holds immense potential to reshape medicine, agriculture, and our understanding of life. But like any powerful tool, it comes with ethical considerations.
Unveiling CRISPR: This naturally occurring bacterial defense system (crRNA & Cas9 protein) fights viruses. Scientists repurposed it for precise gene editing (correction, deletion, insertion) by targeting specific DNA sequences.
The Promise: CRISPR offers exciting possibilities:
Gene Therapy: Correcting genetic diseases like cystic fibrosis.
Agriculture: Engineering crops resistant to pests and harsh environments.
Research: Studying gene function to unlock new knowledge.
The Peril: Ethical concerns demand attention:
Off-target Effects: Unintended DNA edits can have unforeseen consequences.
Eugenics: Misusing CRISPR for designer babies raises social and ethical questions.
Equity: High costs could limit access to this potentially life-saving technology.
The Path Forward: Responsible development is crucial:
International Collaboration: Clear guidelines are needed for research and human trials.
Public Education: Open discussions ensure informed decisions about CRISPR.
Prioritize Safety and Ethics: Safety and ethical principles must be paramount.
CRISPR offers a powerful tool for a better future, but responsible development and addressing ethical concerns are essential. By prioritizing safety, fostering open dialogue, and ensuring equitable access, we can harness CRISPR's power for the benefit of all. (2998 characters)
Navigating the Health Insurance Market_ Understanding Trends and Options.pdfEnterprise Wired
From navigating policy options to staying informed about industry trends, this comprehensive guide explores everything you need to know about the health insurance market.
Struggling with intense fears that disrupt your life? At Renew Life Hypnosis, we offer specialized hypnosis to overcome fear. Phobias are exaggerated fears, often stemming from past traumas or learned behaviors. Hypnotherapy addresses these deep-seated fears by accessing the subconscious mind, helping you change your reactions to phobic triggers. Our expert therapists guide you into a state of deep relaxation, allowing you to transform your responses and reduce anxiety. Experience increased confidence and freedom from phobias with our personalized approach. Ready to live a fear-free life? Visit us at Renew Life Hypnosis..
Navigating Challenges: Mental Health, Legislation, and the Prison System in B...Guillermo Rivera
This conference will delve into the intricate intersections between mental health, legal frameworks, and the prison system in Bolivia. It aims to provide a comprehensive overview of the current challenges faced by mental health professionals working within the legislative and correctional landscapes. Topics of discussion will include the prevalence and impact of mental health issues among the incarcerated population, the effectiveness of existing mental health policies and legislation, and potential reforms to enhance the mental health support system within prisons.
The dimensions of healthcare quality refer to various attributes or aspects that define the standard of healthcare services. These dimensions are used to evaluate, measure, and improve the quality of care provided to patients. A comprehensive understanding of these dimensions ensures that healthcare systems can address various aspects of patient care effectively and holistically. Dimensions of Healthcare Quality and Performance of care include the following; Appropriateness, Availability, Competence, Continuity, Effectiveness, Efficiency, Efficacy, Prevention, Respect and Care, Safety as well as Timeliness.
2. What is NABL ?
NABL specifies the general requirements for the
competence to carry out tests and calibrations,
including sampling. It covers testing and calibration
performed using standard methods, non-standard
methods, and laboratory-developed methods.
3. Benefits of Accreditation:
Potential increase in business due to enhanced customer confidence
and satisfaction.
Savings in terms of time and money due to reduction or elimination
of the need for re-testing .
Better control of laboratory operations and feedback to laboratories
as to whether they have sound Quality Assurance System and are
technically competent.
4. Increase of confidence in Testing / Calibration data and personnel
performing work.
Customers can search and identify the laboratories accredited by
NABL for their specific requirements from the directory of Accredited
Laboratories.
Users of accredited laboratories will enjoy greater access for their
products, in both domestic and international markets, when tested
by accredited laboratories.
5. Types of Laboratory can seek
Accreditation:
Laboratories undertaking any sort of testing or calibration in
the specified fields.
Private or government laboratories.
Small operations to large multi-field laboratories.
Site facilities, temporary field operations and mobile
laboratories.
7. 10 Step Approach To Accreditation
Awareness Training
Quality Policy & Objectives Finalization
Gap Analysis
Documentation / Process Design
Documentation / Process Implementation
Internal Audit
Management Review Meeting
Shadow Audit
Corrective –Preventive Actions
Final Certification Audit
8. Step 1:- Awareness Training
Separate training sessions for top management,
middle management and junior level management.
Creates a motivating environment throughout the
organization for ISO 17025 implementation.
9. Step 2:-Quality Policy & Objectives
Work shop with top management on development
of quality policy.
Work shop with top management and middle level
functional management on development of quality
objectives.
10. Step 3:-Gap Analysis
Understanding of all the operations of the
organization.
Development of process map for the activities of the
organization.
Comparing existing operations with requirements of
ISO 17025:2005 standard.
11. Step 4:-Documentation / Process
Design
Quality Manual
Functional Procedures
Work Instructions
System Procedures
Formats
12. Step 5:-Documentation / Process
Implementation
Work–shop on process / document implementation
as per ISO 17025 requirements.
Departmental / Individual assistance in
implementing the new processes / documents.
13. Step 6:-Internal Audit
Internal Audit Training & Examination (Optional).
Successful employees / we carry out internal audit
of the organization covering all the departments
and operations.
Suggest corrective and preventive actions for
improvements in each of the audited departments.
14. Step 7:-Management Review Meeting
Quality Policy & Objectives
Results of internal audit
Results of supplier evaluation
Results of customer complaints
Results of customer feedback etc.
15. Step 8:-Shadow Audit
A replica of final certification audit.
Finds degree of compliance with ISO 17025
standard.
Gives an idea to the employees about the conduct
of the final certification audit.
16. Step 9:-Corrective –Preventive Actions
On the basis of shadow audit conducted in the last
step, all the non-conformities will be assigned
corrective and preventive actions.
A check will ensure that all the NCs are closed and
the organization is ready for the final certification
audit.
17. Step 10:-Final Certification Audit
Upon completion of various stages of accreditation
audit, the audit, your organization will be awarded
accreditation.