Category: Technology

Workshop Announcement

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ISO 20658:2023 – Workshop Announcement

Workshop on ISO 20658 – 2023. ISO 20658:2023 is a technical specification (TS) that defines the requirements for the collection, transport, receipt, and handling of samples for medical laboratories

The ISO 20658:2023 is an essential resource for all healthcare professionals and medical institutions

Who Can Attend ?

Laboratory professionals : Pathologists, Microbiologists, Bio chemist, Phlebotomist Customer care managers and Quality managers

Program Details :

Date : April 20, 2024
Venue: 8th Floor Auditorium, Kauvery Hospital, Vadapalani, Chennai
Mode : In Person Training (Interactive sessions with case based learning)
Fee – Rs 2000 per delegate

Click here to Register : https://bit.ly/430kbTO

Click here to make payment : https://bit.ly/49Q4cK7

For more details, please contact Ms.Boomadevi @ 9538616636


Do Register and Join the session

One Day National Conference on Standards, Certifications & Regulations

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One Day National Conference on Standards, Certifications & Regulations – Andhra Chamber of Commerce

Andhra Chamber of Commerce, a 95 year old Chamber of commerce with headquarters in Chennai, is organising a One day National Conference on Standards , Certifications and Regulations covering following sectors :

– Agri and Food Products
– Gems and Jewellery
– Leather and Footwear

Program covers sessions on Global Market Opportunities for Businesses and various applicable Domestic and International Standards, Certifications and Regulations the businesses have to comply with, while exporting products.

Program Details are given below :

Date : February 23, 2024 – Friday
Time : 10 am to 5 30 pm
Location : Hotel Ramada Plaza, Guindy, Chennai

Who Should Attend ?

Food & Agri Product Companies, Producer Groups : This is an opportunity for Farmers, FPOs, Producer groups, such as cooperatives, consortiums, and producer organizations, Manufacturers, Exports, Traders, Distributors, Retailers, Resellers, Startups, Innovators, Ecommerce companies, Testing labs, other key stakeholders etc from Food and Agri Products space to understand more about Export Opportunities and related Regulations, Standards , Certifications, Product Testing norms that businesses have to meet to Go Global.

Registration :

There is NO FEE. Program is open for industry members, other stakeholders from respective sectors, but prior registration is a must.

𝐃𝐞𝐥𝐞𝐠𝐚𝐭𝐞 𝐑𝐞𝐠𝐢𝐬𝐭𝐫𝐚𝐭𝐢𝐨𝐧 𝐋𝐢𝐧𝐤 :
https://bit.ly/3T7QdcQ

Do visit Chamber Page for more info, updates
http://www.andhrachamber.com/

It’s an initiative from Chamber to sensitise industry on an ongoing basis about International Trade Opportunities and market access norms that businesses have to comply with

For more details, please contact :

Mr Barnabas Immanuel
Program Co-ordinator
Phone : 24315277/78
Mob:7305063885
Email : andhrachamber1@gmail.com
acc@andhrachamber.com

Click here for Program Brochure
Click here to register

Industry Update – Addendum to NABL 112

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Addendum to NABL 112 document in respect of ISO 15189:2022 version

ISO 15189:2022 is an international standard that specifies the requirements for quality and competence in medical lab environments. It is a standard that requires labs to develop a robust, reliable quality management system (QMS) to establish their competence.

This standard promotes the welfare of patients and satisfaction of laboratory users.

NABL 112 is a Specific Criteria for Accreditation of Medical Laboratories, prepared by a Technical Committee, which is aligned as per ISO 15189: Medical laboratories- Requirements for Quality & Competence

NABl has released the addendum document to NABL 112. Table specifying the applicability of this document to different clauses of ISO 15189:2022 are given below

ISO 15189: 2022 RequirementRefer NABL 112 Issue No. 4 Requirements
5.1 Legal entity
5.2 Laboratory Director		Page No. 10 – Organization and management responsibility
6.7 Service agreements   Agreement with laboratory users Agreement with POCT operatorsPage No. 11 – Service Agreements  
6.8.2 Referral laboratories and consultants
6.8.3 Review and approval of externally provided products and services      		Page No. 11 – 4 Examination by referral laboratories  
5.3.3 Advisory activitiesPage No. 12 – Advisory services
8.4 Control of records   Creation of records Amendment of records Retention of recordsPage No. 13 – Control of records  
8.8 EvaluationsPage No. 14 – Evaluation and audits
6.2 Personnel5.1 Personnel
6.3 Facilities and environmental conditions5.2 Accommodation and environmental conditions
6.4 Equipment
Equipment requirements
Equipment acceptance procedure
Equipment instructions for use
Equipment adverse incident reporting
Equipment records

6.5 Equipment calibration and Metrological traceability

6.5.2 Equipment Calibration  

6.6 Reagents and consumables
Receipt and storage
Acceptance testing
Inventory Management
Instructions for use
Adverse Incident Reporting		5.3 Laboratory equipment, reagents and consumables  
7.2 Pre-examination processes  
Primary Sample collection and handling
Sample transportation
Sample receipt
Pre-examination handling, preparation and storage		5.4 Pre-examination processes  
7.2 Examination processes  
Verification of examination methods
Validation of examination methods
Evaluation of Measurement Uncertainty
Biological reference interval and clinical decision limits Documentation of examination procedures		5.5 Examination processes  
7.3.7 Ensuring the validity of examination results Internal quality Control External quality assessment Comparability of examination results5.6 Ensuring quality of examination results  
7.3 Post examination processes   Reporting of results Post-examination handling of samples5.7 Post examination processes  
7.4.1 Reporting of results
Critical result reports
Special considerations for results
Automated selection, review, release and reporting of results Requirements of reports
Amendments to reported results		5.8 Reporting of results  
7.4.1.2 Result review and release5.9 Release of results
7.6 Control of data and information management  
Authorities and responsibilities for Information management Information Systems management
Downtime plans
Off site management		5.10 Laboratory information management  
Click here to read the Amendment

Source: https://nabl-india.org/

Regulatory Guidelines for Sampling of Drugs

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REGULATORY GUIDELINES FOR SAMPLING OF DRUGS, COSMETICS & MEDICAL DEVICES BY DRUGS INSPECTORS OF CENTRAL & STATE DRUG AUTHORITIES

Drugs Inspectors of Central & State Drug Authorities have released the guidance document for sampling of drugs, cosmetics & medical devices vide their circular dated 9th feb 2024.

This guideline is mainly focused to utilize available information & identified risks for selection of sample & location to cover vast variety of drugs, cosmetic and medical devices moving in the market from manufacturing facility, wholesale outlet, retail outlet, government distribution channel etc.

This guideline will be useful for effective surveillance for quality & efficacy of drugs & cosmetic available in the market by adopting uniform drug sampling methodology for drugs inspectors under drug regulatory authorities of state and central.

The main objective of the sampling is to check the quality & efficacy of drugs & cosmetic available in the market with their approved specifications. This involves:

 Monitoring the quality of the API, Excipients and finished products of drugs, cosmetic and medical devices in all parts of the distribution chain throughout the authorised shelf-life.
 Ensuring that existing control methods are satisfactory.
 Investigating the Not of Standard Quality (NSQ) Product.
 Identifying Unapproved Products/ Without License sales outlets.
 Identifying Spurious drugs in distribution chain
 Identifying sales outlets where repetitive NSQ/ Spurious drugs are reported etc

Click here to read the Circular

Source: https://cdsco.gov.in/opencms/opencms/en/Home/

Industry Update – Program by KIHT

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International Fellowship on Health technology assessment by
KIHT,Visakhapatnam

The 9th International Fellowship on Health technology assessment is being launched by Kalam Institute of Health Technology, Visakhapatnam, to promote the advancement of knowledge and expertise in health technology assessments.

KIHT aims to equip participants with the latest methodologies, best practices, and insights in HTA, empowering them to become leaders in the field.

The 9th International Fellowship on Health Technology is scheduled on 18th to 24th March 2024 at Kalam Convention Center,AMTZ Campus, Visakhapatnam

Program Details are given below:

Date   :  18 – 24 March 2024
Time  :   9.30 am to 5.30 pm
Venue:   Kalam Convention Center C/o AMTZ Campus, Visakhapatnam,Andhra Pradesh- 530031

Program Benefits :

– Conceptual Mastery in HEOR
– Exclusive Insights into Emerging Trends in HEOR
– Proficiency in cutting edge HEOR software
– Access to exclusive Research and Training materials
– Practical knowledge in Study design, Evidence synthesis and Economic modelling
– Exposure to Real world evidence, case studies and applications
– Open discussion with Academicians and Industrial Leaders
– Benefits of mentorship from World renowned Professionals in the field
– Global Networking Precision

Who should attend?

– Healthcare Policy makers and Regulators
– Medical Professionals and Practitioners
– Health Economist and Researchers
– Healthcare Industry and Innovators
– Academicians and Students
– Hospital Administrators

For Fee and other queries: Visit: https://kiht.in/

Contact:
Ms. Kaviya Jeyaram
kaviya.j@kiht.in
+91 8220025552

Mr. Nitturi Naresh Kumar
n.nareshkumar@ibsc-amtz.in
+91 8897330990

Click here to view Agenda

source :https://kiht.in/

Industry Update – QMSR for Medical Devices

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Quality Management System Regulation (QMSR) for Medical Devices

The Quality Management System Regulation (QMSR) for Medical Devices, released by the FDA on January 31, 2024, is a significant update to the existing Quality System (QS) regulation (21 CFR Part 820). This new rule aims to:

Harmonize with international standards, specifically the ISO 13485:2016 standard for medical device quality management systems. This will streamline processes for manufacturers who export to other countries.

Modernize the requirements, reflecting best practices in quality management and aligning with current technologies and approaches.

Increase flexibility for manufacturers, allowing them to tailor their quality systems to their specific needs while still meeting essential safety and effectiveness requirements.

Key points of the QMSR:

Incorporation by reference of ISO 13485:2016: This means that manufacturers can largely follow the ISO standard to meet the FDA’s requirements, with some additional clarifications and modifications outlined in the QMSR.

Focus on risk management: The QMSR emphasizes a proactive approach to identifying and mitigating potential risks throughout the product lifecycle.

Quality by design: The QMSR encourages manufacturers to build quality into their products from the start, rather than relying on inspections and testing to catch problems later.

Increased transparency: The QMSR requires manufacturers to maintain more comprehensive documentation and make certain information available to the FDA upon request.

Important dates:

Publication date: January 31, 2024

Effective date: February 2, 2026

The rule is effective two years after publication in the Federal Register. Until then manufacturers are required to comply with the QS regulation. The FDA will begin to enforce the QMSR requirements upon the effective date, February 2, 2026.

Source: https://www.fda.gov/

Gen – AI – IMF report

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Gen-AI: Artificial Intelligence and the Future of Work

The IMF staff discussion note, “Gen-AI: Artificial Intelligence and the Future of Work” provides a comprehensive analysis of the impact of AI on labor markets globally.  Key points of the report are shared below :

Artificial Intelligence (AI) has the potential to reshape the global economy, especially in the realm of labor markets.

Advanced economies will experience the benefits and pitfalls of AI sooner than emerging market and developing economies, largely due to their employment structure focused on cognitive-intensive roles.

There are some consistent patterns concerning AI exposure, with women and college-educated individuals more exposed but also better poised to reap AI benefits, and older workers potentially less able to adapt to the new technology.

Labor income inequality may increase if the complementarity between AI and high-income workers is strong, while capital returns will increase wealth inequality.

However, if productivity gains are sufficiently large, income levels could surge for most workers. In this evolving landscape, advanced economies and more developed emerging markets need to focus on upgrading regulatory frameworks and supporting labor reallocation, while safeguarding those adversely affected. Emerging market and developing economies should prioritize developing digital infrastructure and digital skills

Click here to read the IMF report

NSW portal for Medical Devices

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Launch of NSW Portal for Medical Devices

Central Government has launched a ‘one-stop-shop’ portal NSWS, designed by Invest India through Tata Consultancy Services (TCS) to streamline the import of medical devices in the country. This will be independent of the existing portals – the SUGAM portal or cdscomdonline portal. The existing portals will be disabled by January 15, 2024

The portal facilitates applications for the certificate of registration and licences to manufacture or import medical devices for various purposes such as clinical investigations, tests, evaluations, demonstrations, or training.

From January 1, 2024, the following three activities under the Medical Devices Rules, 2017 will be made live on the NSWS Portal:

i. application for grant of certificate of registration of a notified body- Form MD -01
ii.application for licence to manufacture medical device for clinical investigations, test, evaluation,  examination, demonstration or training- Form MD -12
iii.application for licence to import medical device for clinical investigations, test, evaluation, examination, demonstration or training- Form MD -16

All the stakeholders should submit the application for the above 3 activities, through NSWS portal only

Click the link below to read the detailed guide book on How to apply for CDSCO approval

Guide book on How to apply for CDSCO approval

Source:https://cdsco.gov.in/opencms/opencms/en/Home/

Tamil Nadu Global Investors Meet 2024

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Tamil Nadu Global Investors Meet 2024

Tamil Nadu, with its robust educational system and a strong focus on Science, Technology, Engineering, and Mathematics (STEM), is rapidly emerging as a leader in the Global Capability Centres (GCC) landscape. The state’s journey from skill arbitrage to leadership arbitrage in this domain is a testament to its growing prowess and the trust it has garnered globally.

GCCs, which have been a part of India’s business ecosystem for decades, are witnessing a significant surge in Tamil Nadu. Renowned companies like Cognizant Technology Solutions (CTS), Genpact, and Flipkart are notable examples of businesses that have thrived in this space. Moreover, the state is becoming a hub for startups in the GCC sector, further diversifying and strengthening its position.

As of 2015, India was expected to host over 2025 GCCs, highlighting the sector’s rapid growth. Tamil Nadu, in particular, has been pivotal in this expansion, offering a market potential that ranges from $35 billion to $60 billion. The state’s ability to create a large number of GCC leaders, estimated between 5,000 to 25,000, is also noteworthy. This growth is attributed to the shifting of markets from the West to India, leveraging the country’s strong STEM education.

One of the key strengths of Tamil Nadu in the GCC arena is the close gap between engineering and end-users. Product managers in the state work closely with customers, unlike in the past, where GCCs focused only on building certain parts. This proximity enables the development of trusted relationships and a deeper understanding of end-user needs.

Talent acquisition and retention are other areas where Tamil Nadu excels. The state’s educational institutions, startups, and industries collaborate closely, creating a robust ecosystem that supports the growth and development of GCCs. This synergy is critical in understanding and adapting to consumption patterns in the fast-growing digital economy.

Despite these strengths, GCCs in Tamil Nadu have faced challenges. Initially, driving business transformation and achieving cost efficiencies were significant hurdles. However, these have been largely overcome, and today the focus is on co-innovation, joint IPs, and skill development in collaboration with the government and academia. Cultural gaps and trust-building, once significant challenges, are now areas where best practices have been established.

Opportunities abound in Tamil Nadu, especially in engineering R&D. Cities like Chennai and Coimbatore are recognized for their skilled talent, particularly in Tier 2 cities like Coimbatore. The state offers a comprehensive product portfolio, facilitated by the proximity of engineers, product managers, architects, and customers.

Tamil Nadu is also home to various GCCs from major players in diverse sectors, each contributing uniquely to the ecosystem. For example, Optimum Health focuses on simplifying and scaling healthcare innovation, while Reynold Nissan GCC leverages core automotive technology for local and global markets. Standard Chartered Bank and UPS have also established significant GCC presences in Chennai, tapping into the diverse talent pool and collaborative ecosystem.

In summary, Tamil Nadu’s strengths in education, innovation, and a collaborative ecosystem make it an ideal location for GCCs. The state’s ability to adapt to changing global needs, coupled with its focus on co-innovation and talent development, positions it as a leader in the GCC landscape. With continued investment and growth, Tamil Nadu is set to play an increasingly vital role in the global GCC sector.

Click the link below to watch the TNGIM2024 Day 1 & Day 2 sessions: https://www.tngim2024.com/live-event-listing

Source: https://tngim2024.com/

Sustainability – Mega opportunity

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In sustainability, a mega opportunity for Indian banks

As India passes the reins of the G20, it has signalled an unwavering dedication to combating global environmental and sustainability challenges. The G20 sustainability working group meetings have spotlighted key pillars: harnessing climate finance, embracing the sustainability development goals (SDGs), and nurturing the financial ecosystem’s capacity.

In parallel, India’s nationally determined contribution commitments to reduce greenhouse gas emissions and the ambitious 2070 net zero emissions target unveil a grand vision of fortifying climate resilience and nurturing sustainable growth.

The big gap: funding the shift to a greener future

Nevertheless, there is a considerable gap between the financial requisites for these ambitions and the current landscape–making for a significant opportunity for India’s banking sector to tap into.

The G20 Leaders declaration underscores the importance of sustainable finance, highlighting needs like for developing countries, blended finance instruments, and reforming multilateral institutions.

Worldwide, banks are increasingly integrating sustainability into their operations. Many have committed substantial funds for sustainability and are transitioning away from fossil fuel financing. They’re also innovating with sustainable finance products like green bonds and leveraging technology for broader customer outreach and lower carbon footprints

While India’s banking sector has begun its ESG journey, it’s still navigating the challenges of balancing sustainability with developmental needs. Drawing from global trends and G20 insights, Indian banks can harness ESG for value creation. By integrating sustainability considerations and technology-driven decision-making, they can champion environmental and social transformation in India’s financial realm.

Indian banks have a pivotal role in driving social change, achieving national objectives, and expanding their lending portfolios.

Their success hinges on accessing global capital, innovating for new segments, and prioritizing digitalization and ESG integration in decision-making.

Achieving these objectives not only promises financial success but also positions Indian banks as leaders in the sustainability transition.

Click here to read the article

source: https://www.livemint.com/

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