Guidelines for Interlaboratory Comparison for Calibration Laboratories where Formal PT Programs are not available Posted on 25.10.2021
NABL has released guidelines for ILC for Calibration Labs where PT Programs are not available.
The guideline is for the Calibration laboratories which are accredited and applicant to NABL. Calibration laboratories shall participate in Proficiency Testing Program of accredited Proficiency Testing Providers. This procedure is be used only as an alternative in the absence of formal Proficiency Testing programs to meet the requirements of NABL 163.
For more information, download the document here :
TiECON Chennai 2021 – 14th Edition of the largest Entrepreneurship Conference of Tamilnadu
Announcement from #TiEChennai TiECON Chennai 2021 is calling !
TiECON Chennai 2021, the 14th edition of the event, is scheduled to happen virtually between November 8th and November 12th, 2021, with speaker sessions in the evenings. This year, our focus will be on how fast and how drastically the rules of business are changing. To remain relevant, adaptability and agility have become very important. To stay in the game, businesses cannot just cope; they need to reinvent the rules. To speak about this changing environment, TiECON Chennai 2021 will be themed on Get Set. Resurge
Be part of Tamil Nadu’s Largest Entrepreneurship Conference.
We also request you to spread the word so that more people can join in this Celebration of Entrepreneurship.
Shaping India’s Medical Devices Regulatory Framework: Global Best Practices and Priorities
India’s medical devices industry is poised for significant growth in the next five years, with the market size expected to reach $50 billion by 2025. It includes both large multinationals and small to medium enterprises (SMEs), and it is growing at an unprecedented scale: its current market size is estimated to be nearly $10 billion.
TIC Council fully supports the crafting of a robust medical devices rules regulatory and policy framework which lays a strong foundation towards ensuring a robust quality and conformity ecosystem for medical devices in India.
In the healthcare sector, patient and operator safety are of paramount importance, which makes it imperative for medical devices to be of high quality and safe for their intended use, therefore a rapidly evolving medical device industry needs hand holding from all stakeholders, in order to be able to realize the government’s vision of quality and affordable healthcare for all.
Embarking on the mission of patient safety in India, TIC council is organizing a two-day webinar on Shaping India’s Medical Devices Regulatory Framework: Global Best Practices & Priorities. The webinar will witness the presence of senior policy makers from Ministries & regulatory bodies of India, E.U & U.S along with senior industry leaders from the medical devices and TIC industry, sharing their experience, global trends and best practices towards ensuing quality and safety of medical devices. This webinar is a must-attend for industry leaders, decision makers, quality, regulatory and public affairs personnel from the healthcare sector.
The webinar will be held in two days: Thursday 28 October 2021, 14:30-17:00 IST (11:00-13:30 CET), and Friday 29 October 2021, 14:30-17:00 IST (11:00-13:30 CET).
Registrations will be open to all TIC Council Members and relevant stakeholders, as well as a larger external audience.
Suresh Sugavanam, Chairman, TIC Council India
Hanane Taidi, Director General, TIC Council
Niranjan Nadkarni, CEO, TÜV SÜD South Asia, South East Asia, Middle East & Africa Region
Karthik Venkataraman, Business Manager, UL India
Claire Dyson, Global Vice President, Dekra
Kimberly Trautman, Medical Device, IVD and Combination Product Regulatory & Quality Expert
Latika Vats, Director, Regulatory Affairs & Quality Assurance for India Medtronic and APAC Med Committee
Reinaldo Figueredo, ISO-CASCO Chair
Sudhir Zutshi, Chair, Public Affairs, Sub Committee, TIC Council India
Dr. R P Singh, Secretary General, QCI
Dr. Shailendra Singh, TUV SUD Pvt Ltd.
Jitendra Sharma, Managing Director and CEO, AMTZ
Ravi Kant, DDC, CDSCO (TBC)
Rajesh Maheshwari, CEO, NABCB
Ravi Singh, Member, TIC Council, Med Device WG
Dr. Girdhar Gyani, Director General, AHPI
Harshit Thakkar, Sr. Project Manager, DEKRA
Sudhakar Mairpadi, Head Quality, Regulatory and Govt Affairs, Philips India Pvt Ltd
Rajiv Nath, Forum Coordinator, AiMED
Vibhav Garg, Director-Health Economics & Govt Affairs, Boston Scientific
R Asok Kumar, Chairman, Regulatory Sub Committee, Adva Med
Dr. Aparna Dhawan, Executive Director, TIC Council India
Training and Capacity Building (TCB) Cell, QCI has announced new batches of virtual training for the months of November & December 2021. Please check program calendar as listed below :
Requirements of ISO/IEC 17065:2012 for Product Certification Bodies
29-30 Nov 2021
INR 5000 +GST
Laboratory System and Internal Audit program as per ISO/IEC 17025:2017$$
19-20 Oct 2021 25-26 Nov 2021
INR 5000/- + GST (18%)
06-07 Dec 2021
ISO/IEC 17025:2017 – Risk Management requirements & implementation in Laboratories
15 Nov 2021
INR 2000/- + GST (18%)
22 Dec 2021
Uncertainty of Measurement and Decision Rule as per ISO/IEC 17025:2017
26-27 Oct 2021 16-17 Nov 2021
INR 3500/- +GST (18%)
22-23 Nov 2021
Medical Laboratory System and Internal Audit program as per ISO 15189:2012$$
11-12 Nov 2021
INR 5000/- +GST (18%)
Lean Six Sigma Green Belt Certification
28-30 Oct 2021
INR 9500/- +GST (18%)
$ eLearning modules for these courses are also available at www.equest.co.in . Once you complete both the courses, you will get an additional ‘Competence Certificate’.
The courses are designed for professionals like quality & senior management professionals from Inspection Bodies, Laboratories, Certification Bodies, Regulators, Government Bodies, Industry, PSUs, Consulting Organizations, Consultants, Training Organizations, Trainers etc.
To deliver quality engagement, only limited number of participants are allowed for the training courses , to give sufficient opportunities for participants to participate in discussions and to clarify their doubts.
After the completion of the course, all the participants will be issued a certificate of participation. Utilise this opportunity to register yourself. We have launched various other trainings in the general domain as well as listed below :
Cost of Quality – A tool for developing Business Case for Quality Improvement Initiatives
Fundamentals of Digital Marketing
Organizational Values, Ethics & Office/Work Place Etiquettes
On eQuest (www.equest.co.in ), an array of courses on domains such as Environment, Laboratories, Quality, Agriculture, Healthcare, and Technology-related fields etc are listed.
A new course developed by NABL on ‘Program for Potential / Accredited / Applicant Proficiency Testing Providers on ISO/IEC 17043:2010” was launched recently . This program is designed for PT Providers to know about standard ISO/IEC 17043:2010 “Conformity Assessment – General requirements for the proficiency testing”.
For registration and payment related queries, please contact, Rohit Varshney, Associate, TCB, QCI, email@example.com, Ph- 9773500376
Department of Biotechnology (DBT), Ministry of Science & Technology, Government of India launched CDSA on 28 September 2009 as an extramural unit of Translational Health Science & Technology Institute (THSTI). It was created to facilitate development of affordable healthcare products for public health diseases. Registered as a not-for profit research organization, it aims to develop an eco-system for training and learning and work with public sector institutions, and small and medium enterprises (SME) to translate innovative technologies into medical products for public good.
There is an ever-growing demand for trained and certified Good Clinical Practice (GCP) professionals in the clinical research arena both in academia and in industry. Setting up an uniform system to achieve the desired competence standard using internationally accepted best practice for ‘Assessment’ and ‘Certification’ is the key to addressing this unmet need.
To this end, a Certification Scheme for GCP professionals based on the International ‘Personnel Certification’ standard (ISO 17024:2012) has been developed by CDSA-THSTI.
The GCP professional certification scheme has two aspects – a system of accreditation of Training Institutions to ensure standardised, high-quality GCP training and GCP Professionals Certification (by Third-Party Certification) to promote certification of professionals both within the country and across the globe.
GCPPCS is owned by the Clinical Development Services Agency (CDSA)-Translational Health Science & Technology Institute (THSTI). THSTI is an autonomous institution under the Department of Biotechnology, Ministry of Science & Technology, Government of India. CDSA-THSTI as Scheme Owner, has the Steering Committee, Technical Committee and Assessment Committee to draft, review and approve the relevant documents and effective implementation of the Scheme. These committees are comprised of multiple stakeholders for example subject and process experts with representatives from ministries, regulator, government agencies, industry, academia, accreditation body, certification body, training institutions and civil society organisations.
Upcoming Program on GCPPCS :
CDSA has successfully completed two webinars for creating awareness and generating interest amongst the Personnel Certification Bodies, Training Institutions and individual GCP professionals for the Good Clinical Practice Professional Certification Scheme (GCPPCS) on September 22 and October 6, 2021.
The next webinar, specifically designed for the Training Institutions, is scheduled for October 20, 2021 from 1400 hrs. Prof Y K Gupta would be delivering the Opening Remarks.
Prof. Debjani Roy Dr. Harish Nadkarni Maheshwari Dr. Sanish Davis Dr. Sucheta Banerjee Kurundkar Mr. S Krishnamurthy Prof. Y.K Gupta
Awareness Programme For Training Institutions on GCPPCS
प्रो. देबजानी रॉय/Prof. Debjani Roy सदस्य सचिव और कार्यक्रम प्रबंधक, जीसीपीपीसीएस /Member Secretary & Program Manager, GCPPCS – Clinical Development Services Agency Translational Health Science & Technology Institute, Department of Biotechnology, Ministry of Science & Technology, Government of India NCR Biotech Science Cluster, 3rd Milestone, Gurgaon- Faridabad Expressway, Faridabad 121001 क्लिनिकल डेवलोपमेंट सर्विसेस एजेंसी, ट्रांसलेशनल हेल्थ साइंस एंड टेक्नोलॉजी इंस्टिट्यूट, विज्ञान और प्रौद्योगिकी मंत्रालय, भारत सरकार Tel: +91-41052296, Email: firstname.lastname@example.org, email@example.com
This announcement has triggered the interest of many and has seen conversations floating around the same .Seen “Appreciations” and also “WATCH OUT Govt Healthcare Initiatives” kind of statements.
Govts, when decide to take control of Healthcare delivery & make right investments, will throw real stiff competition to Pvt Healthcare. Country requires this balancing act in managing communities health.
Govts have not invested into creating Quality Healthcare Infra for decades and pandemic has shown the gaps to communities about the flaws in both Govt and Pvt Hcare Infra in the country.
All 3 As – pillars of Healthcare Delivery, came down crashing or crumbled.
Its hightime Govt Hcare institutions embrace digital healthcare by making right investments to improve Patient experience.
HIS or HIMS has been there in pvt healthcare for more than 2 decades and has not really taken off in a big way.Industry has seen very average utilization rates of around 30% or even less. Reasons for low utilization rates are too many but the key factor is lack of #Upskilling of Health Workers which is critical to make technology usage becomes a culture in any organisation.
Healthcare businesses have to focus in bringing alignment between People & Technologies to streamline their Processes, through massive people upskilling initiatives.
Railways investing into HMIS is a good move. What is needed is strengthening basic IT infra in all hospitals, providing hardware to people (which often doesn’t happen) and massive on the job training for the next 3-4 years to make this initiative very successful. Identifying Change Agents to lead and drive this Change internally is also very important.
User acceptance for digital health was also not there all these years and now users will accept hybrid forms of delivery in many businesses, healthcare being no exception.
With NDHM rollout on the cards, seamless integration of all these tech initiatives into NDHM’S platform become critical.
Railways have created their own HMIS platform.
Read the announcement below from PIB for more information.