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DUBLIN--(BUSINESS WIRE)--Nov 22, 2024-- The "Verification and Validation - Product, Equipment/Process, Software and QMS" training has been added to ResearchAndMarkets.com 's offering. This seminar will provide valuable assistance to all regulated companies that need to review and modify their Master Validation Planning and Plan(s). While this information is focused on Medical Devices, its principles apply to personnel/companies in the Pharmaceutical, Diagnostic, and Biologics fields. Develop/review a company's Master Validation Plan for major cGMP deficiencies. Address the U.S. FDA's newer and tougher regulatory stance. One major failing is lack of sufficient or targeted risk-based V&V planning: Learning Objectives 9.0 RAC CREDITS RAPS - This course has been pre-approved by RAPS as eligible for up to 9 credits towards a participant's RAC recertification upon full completion. Who Should Attend: Key Topics Covered: Session Start Time: 12:30 PM 05:00 - Day One Wrap-up Day 2 Session Start Time: 12:30 PM Speakers: John E. Lincoln Principal Consultant J. E. Lincoln and Associates LLC John E. Lincoln is principal of J. E. Lincoln and Associates LLC, a consulting company, with over 33 years' experience in U.S. FDA-regulated industries and 20 years as a full-time consultant. He has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process/ product/ equipment including QMS and so+E6ftware validations, ISO 14971 product risk management files / reports, design control / design history files, and technical files. He's held positions in manufacturing engineering, QA, QAE, regulatory affairs, to the level of director and VP (R&D). In addition, Mr. Lincoln has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CGMP subjects. He is a graduate of UCLA. For more information about this training visit https://www.researchandmarkets.com/r/yvji9 About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. View source version on businesswire.com : https://www.businesswire.com/news/home/20241122509912/en/ CONTACT: ResearchAndMarkets.com Laura Wood, Senior Press Manager press@researchandmarkets.com For E.S.T. Office Hours Call 1-917-300-0470 For U.S./ CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 KEYWORD: INDUSTRY KEYWORD: MEDICAL DEVICES FDA HEALTH TECHNOLOGY SOFTWARE PHARMACEUTICAL SOURCE: Research and Markets Copyright Business Wire 2024. PUB: 11/22/2024 02:32 PM/DISC: 11/22/2024 02:31 PM http://www.businesswire.com/news/home/20241122509912/en Copyright Business Wire 2024.According to the study, thermal power plants in Bengal produce 313 kilotonnes of sulphur dioxide annually KOLKATA: Coal-fired thermal power plants in Bengal annually emit 18 times more sulphur dioxide than that generated by stubble-burning in Punjab and Haryana, revealed a report by the Centre for Research on Energy and Clean Air. The findings underscore the need to curb the emissions, with experts advocating the installation of Flue Gas Desulfurization (FGD) system. According to the study, thermal power plants in Bengal produce 313 kilotonnes of sulphur dioxide annually, while 17.8 kilotonnes are generated from burning 8.9 million tonnes of paddy straw in Punjab and Haryana. Assembly Election Results 'Ek hain, toh safe hain' is new 'Maha' mantra of India, says PM Modi in victory speech 'Let us take a pledge to build Golden Jharkhand': Hemant Soren after victory 'Cannot believe Maharashtra results': Uddhav vows to keep fighting But despite the continuous pollution , none of the 14 coal-based plants in Bengal, totalling 13.745 GW of installed capacity, has so far installed an FGD, pushing India to be one of the top sulphur dioxide-emission countries globally. India accounted for over 20% of human-made SO2 emission, showed the study. In 2023, India produced 6,807 kilotonnes of SO2 while generating power, surpassing nations, like Turkey and Indonesia. SO2 transforms into sulfate particles, a major component of PM2.5 pollution that poses severe health risks, including respiratory and cardiovascular diseases. CREA's research shows 96% of particulate pollution from coal plants is secondary, arising from chemical transformations of emitted gases, such as sulphur dioxide. Maharashtra Jharkhand Maharashtra Alliance View i Party View Seats: 288 L + W Majority: 145 BJP+ 229 MVA 47 OTH 12 Leads + Wins : 288 / 288 BJP+ WON Jharkhand Alliance View i Party View Seats: 81 Results Majority: 41 INDIA 56 NDA 24 OTH 1 Results : 81 / 81 INDIA WON Source: PValue Despite the ministry of environment , forests and climate change introducing emission standards in 2015, FGD adoption had been slow, said experts. Till Aug this year, only 39 units across the country installed the system, while work was underway at 238 units. Unlike farmers, who were penalised for stubble-burning, thermal power plants often got leniency and extensions for compliance, said experts. If the FGD system was installed at the units, SO2 emissions from Bengal's coal plants could drop by 64%, from 313 kilotonnes to 113 kilotonnes a year. IIT-Delhi estimates that FGD can reduce the concentration of SO2 by 55% within an 80-km radius and sulfate aerosols by 30% up to 100 km. Experts pointed out installing FGDs involved significant costs -Rs 1 crore to Rs 2 crore per megawatt, adding Rs 0.5-0.6 per unit to electricity generation. But, they said, public health benefits outweighed the installation expenses as better air quality could drastically cut down on hospitalisations and deaths from air pollution. With the installation of an FGD system, Farakka STPS, which emits 46 kilotonnes of sulphur dioxide annually, could see a reduction of 73% and Haldia plant 82%. Mejia TPS, Bakreswar TPS and Budge Budge TPS are also projected to achieve significant cuts. The CREA report highlights the need for policy enforcement and investment in emission-reduction technologies like, FGD system.
SC Technology & Aviation Center
MADURAI: Observing that the state government has not yet notified the rules for the Sexual Harassment of Women at Workplace (Prevention, Prohibition and Redressal) Act, 2013 (PoSH Act), the Madurai Bench of Madras High Court directed the government to scrutinise and adopt the model draft rules submitted by the State Women Commission for the Act, after making suitable changes if needed. Stating that the social welfare department is already overburdened, the court also called for creating an exclusive department for women's development. The 140-page order that Justice RN Manjula authored could very well be a major stepping stone in the effective implementation of the PoSH Act in Tamil Nadu. The order was passed on a batch of petitions filed by three women, who were victims of sexual harassment at workplace. After hearing about the uphill battle the women were waging against their management as well as the patriarchal social system to safeguard themselves and punish the perpetrators, the judge observed, "From the victim of Vishaka to the recently reported violence on Apaya, women folk send strong reminders that legislative advancement in addressing workplace harassment did not do marvels.” Referring to a research report submitted by the amicus curiae U Nirmala Rani before the court based on a field Inspection done by two NGOs concerning the existence of internal committee in 60 Institutions, the judge noted that 39 of the 60 institutions do not have the committee; five institutions did not come forward to furnish information as to whether or not they have such committee and only in 16 institutions, the committee are found to be in place. “Though Vishaka guidelines mandated various measures to be taken by establishments to combat sexual harassment in workplaces, there is a lukewarm response and the insensitivity to the menace continues. It is upsetting that directions need to be given to the agencies even after several years to ensure that Internal Committees are in place,” she criticised. Citing another research paper, published by the Department of Criminology of Manonmaniam Sundaranar University by interviewing 1,200 women employees working in public and private sector organisations including victims and non-victims between the age group of 21 to 53 years, the judge noted that 60.7 % of the women employees do not report the sexual harassment to the authority concerned. “The research reports would convey the bitter truth that the Internal Committee mandated under the PoSH Act did not instil confidence in the minds of the affected women to come forward and give the complaint. Apart from the indifference and apathy in the minds of the members of the Committee, the influence exerted by the employers on the committee, reverse actions like retaliations are some of the secondary harassment caused to the victim women,” the judge observed. While the state government has promptly amended its conduct and disciplinary rules, it has not framed its State rules for the PoSH Act, she pointed out and issued the above direction. Also noting that all women welfare projects are entrusted with the Social Welfare and Women Empowerment department, which is also inclusive of child welfare, the judge opined that the social welfare department is already overburdened and it would be difficult for it to monitor the implementation of the mandates of the Act. An exclusive department to care for women development can be better served in the area of women's empowerment, she suggested. She also deemed it fit to issue a series of other directions, such as creating an official government website containing reference numbers of complaints committees, a dashboard with information about number of committees, its members, number of complaints received, resolved, reports submitted and action taken on the reports, steps taken towards allocation and generation of funds for the implementation of the Act, among others. The judge further called for multiple reports from the government regarding the allocation of gender budgets to the social welfare department every financial year, its utilisation, availability of gender cell mechanism and awareness about the same. She also told the government to form a state-level technical committee with qualified persons to prepare module and evaluation questionnaires for gender sensitisation awareness and training programmes. Besides this, she sought a feasibility report from the central and state authorities on 15 other suggestions namely, setting up of separate department for women empowerment, including gender sensitisation questions in competitive examinations and tests conducted for promotions and increment, conducting periodical assessment of gender sensitivity for persons in managerial positions in institutions, making ‘gender sensitivity clearance certificate’ a prerequisite for obtaining all types of licenses, forming gender sensitivity audit squad, appointing technical authorities (gender) at central, state, district, taluk and village level, among others. Appreciating the efforts made by several advocates, especially the amicus curiae U Nirmala Rani, in assisting the court, the judge posted the matter after a month for getting compliance reports and feedback from the authorities.ASP Isotopes (ASPI) Continue to Slump Despite Response to Short Seller Report – Hagens BermanCOP29 deal clinched, what are countries saying?
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