Regulatory guidelines

Medicinal products, pharmaceuticals, veterinary medicines, medical devices, and food supplements all these products are subject to regulations designed by governments to protect public health. The Regulatory Affairs departments of life-science companies ensure that their companies comply with all of the regulations and laws concerning their business. The Regulatory Affairs department is an important part of the organisational structure of pharmaceutical companies. Internally it liaises at the interphase of drug development, manufacturing, marketing and clinical research. Externally it is the key interface between the company and the regulatory authorities. Regulatory Affairs is involved in the development of new medicinal products from early on, by integrating regulatory principles and by preparing and submitting the relevant regulatory dossiers to health authorities. Regulatory Affairs is actively involved in every stage of development of a new medicine and in the post-marketing activities with authorised medicinal products. Regulatory Affairs contributes essentially to the overall success of drug development, both at early pre-marketing stages and at all times post-marketing. The pharmaceutical industry deals with an increasing number of interesting drug candidates, all of which necessitate the involvement of the Regulatory Affairs department. Regulatory Affairs professionals can play a key role in guiding drug development strategy in an increasingly global environment. But they also play an important operational role, for example, by considering the best processes to follow and enabling structured interaction with regulatory authorities. Regulatory Affairs is driven by good science and accordingly nothing remains static. Regulatory affairs professionals are involved in product development from the beginning. Regulatory restraints and requirements need to be considered when drafting the pharmaceutical, preclinical and clinical development plan. Development targets and key claims have to be reviewed and adapted to regulatory guidelines and regulations. Consultations with the appropriate regulatory agencies, for example Scientific Advice procedures in the European Union (EU) or pre-IND meetings with the FDA, are milestones in product development. Regulatory professionals ensure that the information and data to be conveyed and discussed with the regulatory bodies are presented in the right way and form. They develop the regulatory strategy, arrange agency meetings, prepare and compile the questions and briefing documents; they attend the meetings and manage all communication with the agencies. Since the regulatory environment is constantly changing the regulatory team provides advice on necessary adaptations to development plans and target product profiles

MNC JOB N MAINTENANCE ENGINEER FOR FRESHER JOB SKILLS: Documentation review skills Knowledge on Clean room requirements and Regulatory Guidelines Effective problem solving capabilities Excellent Interpersonal, written and communication skills Responsibilities: Prepare specifications for process equipment Prepare Equipment installation drawings and ensure the installation of the equipment as per the same Qualification: B.E/ B.Tech/ Diploma Location: Chennai Timing: Full Time Salary: 12k to 18k For Freshers Exp: Freshers Benefits: OT + Incentives + Increments based on ur Performance. ARREARS & FRESHERS/ EXPERIENCE CAN ALSO APPLY. ROLE: Maintenance Engineer For Further Information Contact Us: HR.DEVI PH - 91760 AND 74708

We are urgently hiring Medical Coders for our client company in Cochin. Overview The Coding Specialist complies with the Official Coding Guidelines in ICD-9- CM/ICD-10-CM and CPT coding conventions to assign diagnoses and procedure codes for SCCA’s outpatient facility fees. Clinical judgment and high level analytical skills are utilized to code and abstract the legal medical record to support appropriate reimbursement, physician documentation improvement, clinical effectiveness, outcome studies, and research to meet regulatory accreditation requirements for state and federal reporting and other external reporting purposes. This position is 100% remote site coding. Responsibilities Quality & Quantity of Work • Maintains 95% coding accuracy Ability to code 52 HAR accounts per day. Dependability • Able to meet deadlines or month-end coding • Able to work remote from home independently • Executes projects independently • Keeps Coding Supervisor informed of progress on coding productivity or projects. • Works independently with minimal supervision Attendance & Punctuality • Maintains absences as identified per policy • Assures appropriate plan established in case of absence • Notifies supervisor when absence is required Problem-Solving • Addresses problems in timely manner • Independently comes up with plan to address problem prior to approaching supervisor Judgment • Ability to assess situations and formulate responses • Involves supervisor as needed to assist Initiative & Creativity • Initiates projects and solutions • Ability to explore new ways of approaching work • Provides creative input • Makes suggestions for improvements • Participates in group discussions and offers suggestions and recommendations Teamwork • Maintains positive working relationships with peers and supervisors • Participates in staff discussions and comes up with positive approaches to meet departmental goals Communication • Ability to communicate effectively in English both orally and in writing • Conveys ideas in clear and concise manner Adaptability & Flexibility • Able to respond to change • Makes recommendations on how to make job more efficient Qualifications Training, Education and Experience (required) • 2 years of outpatient progressive coding experience • Prior ICD-9, CPT, HCPC, abstracting coding experience in an outpatient or hospital setting • RHIT, CCS, CCS-P CPC, CPC-H, Facility Modifiers • Working knowledge of insurance plans, LCD/NCD’s • Prior experience working with clinical professionals • Medical records and EMR/EHR knowledge • Medical terminology, Anatomy and Physiology Education and Experience (preferred) • 5 years of outpatient or inpatient coding experience • Bachelor’s degree • CPC-H, CCS, CCS-P, RHIT, RHIA • Prior oncology or Transplant coding • Prior training e xperience with clinicians • E & M, Surgical and Infusion codingICD10 training and/or Dual/Double coding experience • EPIC HB, 3M encoder ORCA and mindscape experience Coding Knowledge • Understands and applies correct coding guidelines • Understands and applies regulatory and compliance guidelines • Understands and applies APCs • Understands and applies ICD-9, CPT, E&M, procedure codes and modifiers • Understands and applies documentation guidelines Location: Kochi • Office Timings: Should be ready to work in US shifts Interested candidates can apply soon.

Computer System Validation Training @ Gratisol Labs An Upgrading Career For Experience Pharma Professionals. Gratisol Labs Providing Pharmaceutical Computer System Validation For Experience Pharma Professionals. The course provides compliance with GMP requirements and specifically designed for professionals. By using a risk-based approach and in-depth understanding of various CSV methodologies including GAMP5 guidelines, Validations, Annex 11 and the CFR Part 11. Computer system validation is the process of documenting that a computer system meets a set of defined system requirements. Validation of computer systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records is a critical requirement of electronic record. Computer System Validation Modules: • MODULE 1: FDA Regulatory Module. • MODULE 2: Development of Validation Documents. • MODULE 3: Documenting CSV QUALITY EVENTS. Computer system validation deliverables • Validation plan • System risk assessment report • User requirements specification • System configuration specification • Test plan • Installation Qualification (IQ) testing and results • Operation Qualification (OQ) testing and results • Performance Qualification (PQ) testing and results • Optional) Assessment for compliance with regulations pertaining to electronic records and signatures (e.g., 21 CFR Part 11) • Validation traceability matrix • Quality assurance review • Validation summary report • Review of Standard Operating Procedures (SOPs) • Technical support Eligibility: • Bachelor’s degree in a Life Sciences or Information Technology (IT) discipline or equivalent experience preferred. • Minimum of two (2) years of relevant experience in Pharmaceutical Indsustry or quality required. • GxP hardware and/or software experience preferred. • Knowledge of 21 CFR Part 11 / Annex 11 regulations preferred. • Knowledge of cGMP and validation regulations and requirements. • Knowledge of GMP, GLP, GDP, pharmacopoeial and regulatory requirements preferred. • Detail oriented with strong written and verbal communication skills. • Ability to work independently, within prescribed guidelines, or as a team member. Venue: Gratisol Labs, KVR Enclave,2nd Floor, 207, Ameerpet, Hyderabad. Land Mark: Gurudwara Contact - show contact info / show contact info

Bharat Book Bureau Provides the Trending Market Research Report on “U.s. non-invasive prenatal testing market Research and Outlook, 2021 - Trends, Growth Opportunities, Competitive Analysis and Forecasts to 2028” under Life Sciences Category. The report offers a collection of superior market research, market analysis, analysis, competitive intelligence and Market reports. The United States Non-Invasive Prenatal Testing (NIPT) Market is expected to touch a valuation of USD 2.5 Billion by 2028. The U.s. non-invasive prenatal testing market is growing with the increasing per capita income, growing interest, increase in incidences of chromosomal aneuploidies among fetus, development of advanced non-invasive prenatal testing products, rising awareness regarding non-invasive prenatal testing, rising focus on reimbursement for NIPT, increasing preference for non-invasive techniques over invasive methods and ACOG guidelines recommend NIPT for all pregnancies regardless of risk. The market shows high potential for growth in the future. This new market report presents a comprehensive study of the entire United States non-invasive prenatal testing market. The report offers the most up–to–date industry data on the actual market situation and future outlook for the United States' non-invasive prenatal testing market. The report also provides up–to–date historical market size data for the period 2015 – 2020 and an illustrative forecast to 2028 covering key market aspects like market value and volume for non-invasive prenatal testing in the United States. This Comprehensive Report Provides: • To Analyse the Historical Growth in the Market Size of the United States Non–Invasive Prenatal Testing Market from 2015 to 2020. • To Estimate and Forecast the Market Size of the United States Non–Invasive Prenatal Testing Market from 2021 to 2028 and Growth Rate until 2028. • The Market Size of the United States Average Risk Non–Invasive Prenatal Testing Market with Seven Years Forecast • The Market Size of the United States High-Risk Non–Invasive Prenatal Testing Market with Seven Years Forecast • Evaluates the Number of NIPT Tests Performed in the United States with Seven Years Forecast • Studies the United States Number of Average Risk NIPT Tests Performed with Seven Years Forecast • Examines the United States Number of High-Risk NIPT Tests Performed with Seven Years Forecast • Assessment of Market Potential and Opportunities for this Innovation-Driven United States Non–Invasive Prenatal Testing Market with Seven Years Forecast • Insights into the United States Average and High-Risk Potential NIPT Tests Market with Seven Years Forecast • Meticulously Assesses the Overall United States Potential Non–Invasive Prenatal Testing (NIPT) Volume and Future Trends • Analyses of the United States Average and High-Risk Potential Number of Tests Performed with Seven Years Forecast • Detailed Insights into the Regulatory Framework of the United States Non–Invasive Prenatal Testing Market • Features Reimbursement Patterns of the United States Non–Invasive Prenatal Testing Market • Tracks Competitive Developments, Approaches, Recent Industry Developments, Mergers & Acquisitions, Collaboration Deals, Partnership Deals, Distribution, Exclusive, and Licensing Agreement • A Comprehensive List of the Key Players Along with the Analysis of their Current NIPT Test Portfolios, Business Overview, and Recent Development The Leading Companies for the United States Non–Invasive Prenatal Testing Market are Listed Below: • Illumina • Natera • Quest Diagnostics • Myriad Genetics • Centogene • GenPath • Progenity • PerkinElmer • Yourgene Health • Invitae Corporation • Agilent Technologies • Ariosa Diagnostics (Roche) • Integrated Genetics (LabCorp) Key Questions Answered in this Report: • What is the current scenario of the United States non–invasive prenatal testing market ? • What is the total market size and forecast (until 2028) for the United States non–invasive prenatal testing market? • How has the potential market performed so far and how will it perform in the coming years? • How many NIPT tests being performed in the U.S. during 2015 – 2028? • What is the market size of the average risk NIPT tests in the United States? • What is the market size of the high-risk NIPT tests in the United States? • What are the key marketed NIPT tests available in the United States? • What are the major drivers of the United States non–invasive prenatal testing market? • What are the major inhibitors of the United States non–invasive prenatal testing market? • What is the reimbursement pattern in the United States non–invasive prenatal testing market? • What is the regulatory framework in the United States non–invasive prenatal testing market? • What are the major deals and agreement happenings in the United States non–invasive prenatal testing market? • Who are the top market players? What are their happenings, current developments, and scenarios? • How is the market predicted to develop in the future? Browse our full report with Table of Content: https://www.bharatbook.com/report/697739/us-non-invasive-prenatal-testing-market-research-and-outlook-trends-growth-opportunities-competitive-analysis-and-forecasts-to About Bharat Book Bureau: Bharat Book is Your One-Stop-Shop with an exhaustive coverage of 4,80,000 reports and insights that includes latest Market Study, Market Trends & Analysis, Forecasts Customized Intelligence, Newsletters and Online Databases. Overall a comprehensive coverage of major industries with a further segmentation of 100+ subsectors.

Dear Candidates, Greetings for the day.!!! Urgent hiring For Hardware networking eng.in pune and Pcmc. Vacancies are:Hardware Network Support Eng. Job Duties:- Aside from setting up systems, network support engineers also monitor and maintain computer systems. This may include troubleshooting wide area networks, servers and routers, local area networks, and switches. Additionally, these professionals may install or upgrade software and hardware. Other duties are responding to technical inquiries, logging service and repair, creating manuals and guides, and training clients, staff, and associates. Requirements: Excellent Writing or Oral Communication Skills in Hindi/ Marathi/English & Any Languages. Good In Technical Knowledge & Good In Technical Coding. Qualification:- Bachelors degree in computer science/Graduation /Post Graduate /BE/B.Tech/(BE) (BSC) (BCA) Or Diploma Completed Fresher & Experience (Male &Female)Both Are Welcome. Basic Computer Knowledge & Knowledge For Drawing. Ethernet networking systems. Familiarity of TCP/IP based protocol. Experience with board level hardware development. Experience trouble shooting electronics to the component level. Familiarity with PCB design tools (PADS a plus). Experience with high speed pcb layout guidelines. Familiarity with general lab equipment. Experience with EMC regulatory compliance guidelines. Fiber Optic experience a plus & VHDL experience a plus. CCNA Certified Complete. Excellent Presence of Mind. Govt. ID Proof. (Any) Able to work in Rotational Shifts In Any location of Pune. Benefits: Pickup and Drop Facility.(Optional) Fast Growth Opportunities. Canteen Facilities.(Optional) Location: All over pune And Pcmc. All The Best !! Thanks & Regards drushti Human Resources Department.

I'm a qualified personal trainer offering personal training in Hyderabad: "My industry is not well regulated." I can tell you from experience that many trainers working both independently and in gyms have no certification or credentials that qualify them to train others. How can that be? Well, a single regulatory body for personal trainers does not exist. There are countless different personal training certifications or certificates available. Not all are created equal (more on that later). Unlike dietitians, which have specific roles, responsibilities and guidelines they must adhere to by law, no such regulations or laws exist for personal trainers. By law, for example, a person must meet certain requirements to call himself or herself a dietitian or nutritionist. In contrast, there is no law that stipulates what is required for someone to attach the status "personal trainer" to his or her name, so be wary. Yes, there may be some exceptions to this rule. An experienced professional with a master's degree in exercise physiology is probably more qualified than many personal trainers whose only experience comes from their weekend certification course, but unless you know everything about that person's education, background and experience, a certification is still a good thing to look for. Some are putting people who trust them at risk by having them perform unsafe exercises or giving them dangerous advice. You should be able to trust your personal trainer, right? Well, not all the time.

Working in coordination with Principal Investigator and study team to conduct trial in accordance with protocol, ICH GCP and regulatory requirement. Maintain and Update site file in accordance with GCP and Sponsors SOP. Provide update on patient recruitment PI, Sponsor and CRO. Assist PI to Managing (timely manner reporting and updating) the adverse events, adverse event of special interest & serious adverse events to CRO, Sponsor and E.C. Assist PI to report SAE, Death reporting, endpoint reporting to the Sponsor and helping the PI in transcribed these events in EDC or paper CRF. Assist PI in making of narrative of these events. Monitored all source documents, Lab reports, Medical records and all study related records before transcribe eCRF and CRO monitoring. Facilitate monitoring visit and prepare the required documents for monitoring visit. Make documents available for monitoring visit. Case Report Form (both eCRF and Paper CRF) completion according to the CRF completion Guidelines. Scheduling & Organizing Patient s follow up visits. Maintain communication between the sponsor, site and ethics committee. Resolution of DCF Resolution of queries

Civil site Engineer immediately wanted in Singapore Qualification: BE Civil PASS: S pass WORK EXPERIENCE: 3 YEARS must /Singapore return workers are most welcome Job brief We are looking for an innovative Civil engineer to design, develop and construct a huge range of projects of the physically and naturally built environment from conception through to completion. You will have a say in how the world looks like, work in a fast growing dynamic industry, contribute towards healthy economies and make a lasting positive impact to society. Responsibilities Manage, design, develop, create and maintain small-scale through to large-scale construction projects in a safe, timely and sustainable manner Conduct on site investigations and analyze data (maps, reports, tests, drawings and other) Carry out technical and feasibility studies and draw up blueprints that satisfy technical specifications Assess potential risks, materials and costs Provide advice and resolve creatively any emerging problems/deficiencies Oversee and mentor staff and liaise with a variety of stakeholders Handle over the resulting structures and services for use Monitor progress and compile reports in project status Manage budget and purchase equipment/materials Comply with guidelines and regulations including permits, safety etc and deliver technical files and other technical documentation as required Requirements Proven working experience in civil engineering Excellent knowledge of design and visualizations software such as AutoCAD,Civil 3D or similar Proficiency in site layout, grading, utility design, erosion control, regulatory approvals etc Project management and supervision skills Strong communication and interpersonal skills License of professional engineer BS/MA in Civil Engineering ONLY EXPERIENCE CANDIDATE CAN APPLY

Job Title: Trainee Asst. Department: The spectrum of consultancy services include inter-alia, Project Management Consultancy (PMC) works, IT implementation in Power Sector, Smart Metering, Smart Grid, Solar Projects, Third Party Quality Inspection, Monitoring of Rural Electrification works, Feeder Renovation Program, Energy Audit, HVDS study, Load flow study of power system networks, preparation of Detailed Project Report (DPRs), Power Transmission network and other power projects including various Govt. of India Schemes viz., DDUGJY, R-APDRP, IPDS, PMDP etc. to the Central/State power utilities across the Country, Consultancy Assignments to Government, Central/State Electricity Regulatory Commission. Educational Qualifications: BE/B.Tech Engineering or equivalent in concerned discipline with not less than 50% marks in aggregate for all candidates. Work Experience: Fresher Total Vacancy: Location: India Remuneration(per month): An initial consolidated amount of Rs. 80,000 per month, all inclusive. The consolidated remuneration will be increased @ 5% for each succeeding year subject to satisfactory performance. Civil Engineer Duties and Responsibilities Civil Engineer job description should contain a variety of functions and roles including: Manage, design, develop, create and maintain projects Conduct on site investigations and analyze data (maps, reports, tests, drawings and other) Carry out technical and feasibility studies Draw up blueprints according to technical specifications Assess potential risks, materials and material and labor costs Provide advice and suggestions to resolve problems Oversee and mentor staff Liaise with a variety of stakeholders Monitor progress of projects Produce reports in project status Manage budget and purchase equipment/materials Comply with guidelines and regulations including permits Civil Engineer Requirements / Skills / Qualifications Civil Engineer job description should include these common skills and qualifications: Registration/License as a Professional Engineer may be required. Familiarity with design software, such as Autodesk, AutoCad Civil 3D, and MicroStation. Knowledge of map creation software and photo imaging software. Strong analytical and critical thinking skills, with a high level of accuracy in calculations and design. Excellent time management skills to ensure project deadlines are met. Leadership skills to effectively manage a diverse group of professionals working on one project. Ability to coordinate more than one project at a time.