- Sunando Basu has over 14 years of experience in quality assurance, with expertise in GLP, GCP, ISO standards, and regulatory compliance.
- He has worked in various roles such as quality assurance auditor, manager, advisor, and trainer at several contract research organizations.
- Currently he is working as a quality management specialist at Krish Biotech Research, where he establishes quality systems and provides GLP consultancy.
Qms NATIONAL ACCREDITATION BOARD FOR TESTING AND CALIBRATION LABORATORIES (...Dr Ajay Kumar Tiwari
Fundamental knowledge on pharmaceutical
product development and translation from laboratory to market.
Quality management systems: Quality management & Certifications.
1. Introduction to NABL
2. NABL and ISO Principles
3. Need of NABL
4. Recognition of NABL in International Level
5. Scope of NABL
6. Advantages of NABL
Quality management systems: Good Laboratory Practice (QMS GLP)Dr Ajay Kumar Tiwari
Fundamental knowledge on pharmaceutical
product development and translation from laboratory to market.
Quality management systems: Quality management & Certifications.
1. Introduction to GLP
2. Definition of GLP
3. Fundamentals of GLP
4. GLP Principles
5. Aim of GLP
Qms NATIONAL ACCREDITATION BOARD FOR TESTING AND CALIBRATION LABORATORIES (...Dr Ajay Kumar Tiwari
Fundamental knowledge on pharmaceutical
product development and translation from laboratory to market.
Quality management systems: Quality management & Certifications.
1. Introduction to NABL
2. NABL and ISO Principles
3. Need of NABL
4. Recognition of NABL in International Level
5. Scope of NABL
6. Advantages of NABL
Quality management systems: Good Laboratory Practice (QMS GLP)Dr Ajay Kumar Tiwari
Fundamental knowledge on pharmaceutical
product development and translation from laboratory to market.
Quality management systems: Quality management & Certifications.
1. Introduction to GLP
2. Definition of GLP
3. Fundamentals of GLP
4. GLP Principles
5. Aim of GLP
NABL stands for the National Accreditation Board for Testing and Calibration Laboratories. This body functions independently under Department of Science and Technology of the Indian Government. NABL is registered via the societies act
Quality management systems: Good Laboratory Practice (QMS GLP)Dr Ajay Kumar Tiwari
Fundamental knowledge on pharmaceutical
product development and translation from laboratory to market.
Quality management systems: Quality management & Certifications.
1. Introduction to GLP
2. Definition of GLP
3. Fundamentals of GLP
4. GLP Principles
5. Aim of GLP
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.
Medical Laboratory Accreditation and its utilization in Japan - Katsuo KubonoMara International
The 3rd GCC Laboratory Proficiency Conference is organized as part of the strategic orientations of the GCC Standardization
Organization (GSO) for the development of the standardization and quality infrastructure, thereby contributing to the development of commerce and industry and to the support of national economy in the GCC member states.
Since the field of proficiency testing is newly introduced in the GCC member states and as the infrastructure of laboratories has not yet taken the shape of national or regional organizations representing the laboratories and reflecting their requirements, GSO is in need of meeting with a considerable group of laboratories to explore and prioritize GCC member states’ requirements in terms of the fields which must top the list of the fields to be developed and upgraded.
Based on the study conducted by GSO during 2011 on the status of proficiency testing activities in the member states which shown that the laboratories operating in the member states are in need of a unified data center on proficiency testing activities, GSO
organized two conferences in 2013 and 2014 on the subject. The conferences scored high rates of success in terms of the selected scientific material, quality of speakers and the targeted audience.
Accordingly, GSO conceptualization of the method of coordinating and upgrading the activity of proficiency tests in the GCC member states included a recommendation on the organization of annual training courses and awareness symposia by the GSO on the fields of proficiency tests.
This year’s Conference will be held in Dubai during two days the 24th and 25th of March 2015, and will coincide with the annual Analytical Industry exhibition ARABLAB which will be held in Dubai during the period 23 – 26 March 2015.
Stabicon specialized in managing product quality process, upgrading and introducing advanced technology into products. We are proud to lay a foundation for prosperous future in prevention and cure segment, future medicine & FMCG business. Established in September 2010. Team experience across from design to concept, lab to commercialization of product and with competent technical experts. Automated process driven and prepared for integration with partner site for transparency and real time access on each application.
NABL stands for the National Accreditation Board for Testing and Calibration Laboratories. This body functions independently under Department of Science and Technology of the Indian Government. NABL is registered via the societies act
Quality management systems: Good Laboratory Practice (QMS GLP)Dr Ajay Kumar Tiwari
Fundamental knowledge on pharmaceutical
product development and translation from laboratory to market.
Quality management systems: Quality management & Certifications.
1. Introduction to GLP
2. Definition of GLP
3. Fundamentals of GLP
4. GLP Principles
5. Aim of GLP
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.
Medical Laboratory Accreditation and its utilization in Japan - Katsuo KubonoMara International
The 3rd GCC Laboratory Proficiency Conference is organized as part of the strategic orientations of the GCC Standardization
Organization (GSO) for the development of the standardization and quality infrastructure, thereby contributing to the development of commerce and industry and to the support of national economy in the GCC member states.
Since the field of proficiency testing is newly introduced in the GCC member states and as the infrastructure of laboratories has not yet taken the shape of national or regional organizations representing the laboratories and reflecting their requirements, GSO is in need of meeting with a considerable group of laboratories to explore and prioritize GCC member states’ requirements in terms of the fields which must top the list of the fields to be developed and upgraded.
Based on the study conducted by GSO during 2011 on the status of proficiency testing activities in the member states which shown that the laboratories operating in the member states are in need of a unified data center on proficiency testing activities, GSO
organized two conferences in 2013 and 2014 on the subject. The conferences scored high rates of success in terms of the selected scientific material, quality of speakers and the targeted audience.
Accordingly, GSO conceptualization of the method of coordinating and upgrading the activity of proficiency tests in the GCC member states included a recommendation on the organization of annual training courses and awareness symposia by the GSO on the fields of proficiency tests.
This year’s Conference will be held in Dubai during two days the 24th and 25th of March 2015, and will coincide with the annual Analytical Industry exhibition ARABLAB which will be held in Dubai during the period 23 – 26 March 2015.
Stabicon specialized in managing product quality process, upgrading and introducing advanced technology into products. We are proud to lay a foundation for prosperous future in prevention and cure segment, future medicine & FMCG business. Established in September 2010. Team experience across from design to concept, lab to commercialization of product and with competent technical experts. Automated process driven and prepared for integration with partner site for transparency and real time access on each application.
Concepts of GLP and ISO 9000. The Good Laboratory Practices Guideline (GLP) is an FDA regulation. Good Laboratory Practices (GLP) embodies a set of principles that provides a framework within which laboratory studies are planned, performed, monitored, recorded and reported. National Good Laboratory Practice (GLP) Compliance Monitoring Authority (NGCMA). NGCMA was established by the Department of Science & Technology (DST), Government of India, with the approval of the Union Cabinet on April 24, 2002.
ISO 9000 is a series of standards, developed and published by the International Organization for Standardization (ISO), which is an independent, non-governmental organization made up of members from over 160 countries.
The ISO 9000 family of standards is related to Quality Management Systems and designed to help organizations ensure that they meet the needs of customers and other stakeholders while meeting statutory and regulatory requirements. ISO 9000 deals with the fundamentals of quality management systems, including the 7 Quality Management Principles on which the family of standards is based.
We focus on providing you lab testing services that accelerate R&D intensive projects. Follow us to share & learn about analytical testing research and more.
2. SUNANDO BASU
M.Pharm (Quality Assurance),RQAP-GLP, MRQA
Qualified QA Auditor (ISO 19011:2002)
Trained in GLP from WHO-TDR, BARQA (UK)
Trained in GCP and UK Clinical Trials from BARQA (UK)
Benchmarked ICH-GCP from Infonetica Ltd
Familiar with ISO-9001:2008 revision
14 Years of Experience in Quality Assurance (GLP plus GCP)
Added Capabilities: GMP, ISO 9001:2008, ISO 17025, ISO 15189 knowledgeable
Way to My Professional Life
3. Quality System Engineering Specialist
Quality Assurance and Regulatory Compliance Analyst
Statistical and Risk Based Audit and Inspection Expert
Standard Operating Procedure (SOP) Management Advisor
Training/Mentoring Instructor
Document/Database Compliance Assessor
Instrument/Equipment qualification/validation
Regulatory Advisor
Regulatory and Client Inspection hosting expert
People Management acquainted
Drug Development (Preclinical to clinical Stage) knowledgeable
Certified GLP (Good Laboratory Practices) and GCP (Good Clinical Practices) Professional
Core Competencies
4. Problem solving
Capable of analyzing and debating complex issues
Superb organization, communication and presentation skills
Possess strong leadership and people management skills
Capable of dealing effectively within cross-disciplinary teams and with vendors
Strong knowledge of quality assurance processes and procedures
IT Skills: MS application (word-processing, spreadsheet, and database)
Skills
5. First Association with…
TORRENT RESEARCH CENTRE of TORRENT PHARMACEUTICAL LTD
From- 2001 to 2005
Achievements:
After Completion of Post Graduation M. Pharm specialization QUALITY ASSURANCE…
Conducted more than 100 statistical based preclinical Study Audit, more than 50 BA/BE
studies, critical Process Audit and Facility Audit including computerized audit as QA Auditor
Structured many In-House Training Program and Workshops
Established OECD GLP components
Identified and implemented more than 500 Standard Operating Procedure
Performed the role of a Regulatory Advisor, towards Contemporary Drug Development
Process of the New Chemical Entities, and on IND (Investigational New Drug Application)
filing to project team in the internal meeting providing compliance advice and guidance
Established ICH Good Clinical Practice (GCP) requirements
Hosted Regulatory Inspection successfully
6. Second Association with…
ACCUTEST RESEARCH LABORATORIES LTD (Clinical Service Contract Research Organization)
From- Jan’2006 to Aug’2006
Achievements:
Established Quality System as per the ICH Good Clinical Practice (GCP) regulations for
various regulatory bodies through the preparation of Quality Policies
Managed a group of 8 QA professional
As a Manager, handled Audit and Inspection mainly scheduling, resourcing and allocation
Responsible for generating and providing status and trend reports to the management,
identification of quality risks and risk prevention strategies, ensuring Corrective and
Preventative Action (CAPA) plans are generated and closed and documented and that the
Quality Documents remains compliant with all applicable laws and regulations
Performed the role of the Mentor to train staff on GXP issues
Hosted client and regulatory inspections
7. Third Association with…
TCG LIFESCIENCES LTD , CHEMBIOTEK (Discovery Research Services Company)
From- Sep’2006 to May’ 2011
Achievements:
Principal in developing and implementation of the following quality components:
Standard Operating Procedures management system.
Good Documentation Practice and Document control.
Induction training Program.
Concept of Staff Records Management.
Instrument/Equipment Management Application system.
Inventory Management System.
Laboratory monitoring procedure across the different departments.
Safety and Waste Management system.
System of Good Archival Practice.
As a manager, responsible for day to day QA activities
8. Present Association with…
KRISH BIOTECH RESEARCH PVT LTD (CRO offering Pre-clinical and Analytical Chemistry
Services)
From- October’2011 to till date…
Responsibilities:
Quality Management System establishment
Supervision of QA programs and day to day activities
Audit Management including Third Party and Vendor Audit
SOP Management
Document Management
Archive Management
Training and mentoring of staff on various GXP topics
GLP consultancy to project team
Hosting and communicating with Client and Regulatory Agencies
Leading, and motivating cross functional employees to ensure GLP compliance
9.
10. Continuous Learning/Benchmarking activities
Diploma in Pharmaceutical Marketing Management from Institute Of Pharmaceutical Education and Research,
Pune, India .
Demonstrated the knowledge on The Principles of Good Laboratory Practice for Professional Auditor conducted
by British Association of Research Quality Assurance (BARQA)-United Kingdom.
Accomplished the distance learning course on Decision Points in Drug Development sponsored by Pharmaceutical
Education and Research Institute, Inc (PERI)-USA .
ISO 19011:2002 (Quality and/or Environmental Management Systems Auditing) exam conducted by British
Association of Research Quality Assurance (BARQA)-United Kingdom .
Participated in USFDA’s course on “Drug Review and Related Activities in the United States” scoring 89.47 %.
August’1996
August 19th, 2005
October 28th, 2005
November 4th, 2005
11. Continuous Learning/Benchmarking activities
Passed Inspector Self-Study: eLearning, sponsored by The College of American Pathologists ,USA.
Benchmarked ICH−Good Clinical Practice knowledge from Infonetica Ltd endorsed by Royal Holloway, University
of London .
Passed Open Access GCP Test from Pharmaschool -UK .
March 12th, 2006
August 7th, 2010
August 10th, 2010
Earned the Registered Quality Assurance Professional designation in Good Laboratory Practice from Society of
Quality Assurance (SQA)-USA
Trained in ICH-GCP from British Association of Research Quality Assurance (BARQA)-United Kingdom .
E-Trained UK Clinical Trial Regulation from British Association of Research Quality Assurance (BARQA)-United
Kingdom .
Awareness on ISO-9001:2008 Changes; Institute of Sigma Learning Pvt Ltd, India
October’2010
November’2010
November’2010
Janaury’2011
12. Poster presentation titled “Performance Measurement of the Documentation
Practice in a Non-Regulated Research Area” at BARQA (British Association of
Research Quality Assurance) 2009 Annual Conference – Brighton.
Was judged Third Best by BARQA’s Publication Committee (British Association of
Research Quality Assurance), United Kingdom for the Article titled “QA Professional:
Attributes and Roles”.
28th October 2009
December’2009
International and National Contribution So Far…
13. Poster presentation titled “ Team Excellence: An Important Factor That Contributes To
Quality Culture ” at BARQA (British Association of Research Quality Assurance) 2010
Annual Conference – Leeds.
Awarded with First Prize by BARQA’s Publication Committee (British Association of
Research Quality Assurance), United Kingdom for the article titled “Horoscope: QA
Professional”
2nd - 5th November 2010
December’2010
International and National Contribution So Far…
Addressed the topic “GLP-Documentation” at Indian Pharmaceutical Association
Auditorium, Kolkata, India
December’2010
14. Subjects that I have acted as a Mentor (In-House)
Good Laboratory Practice Requirements and How to Comply
Good Laboratory Practice for Study Personnel
Proficiency Testing as per ISO 17025
Equipment Qualification
Records and Recording
SOP-An Effective Communication Tool
Structuring QA in Non-regulated Early Research
Computerized System Compliance-A must to do
Raw Data Documentation