223 Fda Jobs - Page 8

Responsibilities : Verification and Validation: Lead the verification and validation of analytical and microbiological methods, ensuring they meet all regulatory and internal quality requirements. Design, execute, and document method validation protocols, including accuracy, precision, specificity, and robustness studies, in compliance with FDA, TGA, ICH, and EMA guidelines. Review and approve validation protocols and reports, ensuring they are scientifically sound and fully compliant with Good Laboratory Practice (GLP) and other relevant regulatory standards. Analytical and Microbiology Methods: Provide expert review and oversight of analytical and microbiological testing protocols, data, and reports, ensuring compliance with regulatory standards and internal quality systems. Oversee the development, validation, and implementation of new analytical and microbiological methods and, including but not limited to chemical analysis, sterility testing, microbial limits testing, and endotoxin testing. Ensure that all methods are validated to provide reproducible and accurate results, adhering to FDA, TGA, ICH, and EMA requirements Data Review and Integrity: Conduct thorough reviews of raw data and final reports related to analytical and microbiology testing and method validation. Ensure that all data generated during analytical and microbiological testing is accurate, complete, and adheres to the approved protocols and SOPs. Identify and resolve any data discrepancies or deviations from established protocols. Regulatory Compliance: Ensure that all analytical and microbiological methods and validations comply with FDA, TGA, ICH, and EMA regulations. Assist in the preparation of documentation for regulatory submissions, providing quality assurance support for analytical and microbiological data and validation reports. Continuous Improvement: Contribute to the development and continuous improvement of quality systems related to analytical and microbiological methods and validation processes. Participate in root cause analysis of quality issues and support the implementation of corrective and preventive actions (CAPAs). Training and Development: Provide guidance and training to RD staff on best practices in analytical and microbiological testing, method validation, and quality assurance. Act as a mentor and resource for junior staff in the areas of analytical development, microbiology and quality assurance What youd gain: Invaluable hands-on experience working alongside seasoned developers. Opportunity to learn and grow in a supportive environment. Gain exposure to the entire software development lifecycle. Contribute to real-world software projects and make a positive impact. Qualifications: Bachelors degree in Chemistry, Microbiology, Biology, Pharmaceutical Sciences, or a related scientific discipline is required. Advanced degree (Masters or Ph.D.) in a related field is preferred. Minimum of 5-7 years of experience in quality assurance with a focus on analytical, microbiology, method verification, and validation within the pharmaceutical, biotech, or life sciences industries. Extensive experience with analytical and microbiological testing methods, including method verification, validation, sterility, microbial limits, and endotoxin testing. Strong expertise in analytical and microbiological methods and their application in product development. Excellent attention to detail and analytical skills with a focus on data integrity and accuracy. Strong written and verbal communication skills, with the ability to document and present complex technical information clearly. Ability to work effectively in a team-oriented environment and collaborate across multiple departments. Proficiency with quality management systems and software tools. This position is remote and may require occasional travel to other sites or meetings. The role may involve working in a laboratory environment with exposure to chemicals and biohazardous materials.

We are looking for an experienced Senior Implementation Specialist with deep expertise in the life sciences industry to lead and execute complex implementations of our technology solutions. This role requires a seasoned professional with over 10 years of implementation experience, strong technical knowledge, and a proven track record in the life sciences domain. The ideal candidate will ensure seamless deployment, integration, and optimization of Freya Fusion, managing both client expectations and regulatory requirements. Key Responsibilities: Project Leadership : Lead the end-to-end implementation of Freya Fusion, overseeing all phases from project scoping and requirements gathering to configuration, testing, and go-live. Client Relationship Management : Act as the primary point of contact for clients, offering expert guidance, managing expectations, and consistently maintain positive relationships to ensure successful adoption of Freya Fusion. Solution Configuration : Collaborate closely with technical teams to configure Freya Fusion according to client specifications, ensuring integration with existing enterprise systems and compliance with industry standards. Data Migration & Compliance : Manage and execute data migration strategies, conducting thorough data validation to ensure accuracy and compliance. Detailed Project Planning : Develop and maintain comprehensive project plans, including timelines, resource allocations, and milestones, while actively identifying and mitigating risks. Regulatory Compliance : Ensure all implementations meet global regulatory standards relevant to the life sciences industry (FDA, EMA, GxP, etc.), maintaining clear documentation for compliance and audit purposes. Client Training & Post-Implementation Support : Conduct training sessions, develop user guides, and provide continued support to clients to facilitate seamless onboarding and system adoption. Process Improvement : Collaborate with internal teams to continuously improve implementation processes, sharing insights to enhance client satisfaction and optimize solution delivery. Required Qualifications: Educational Background : Bachelors degree in Life Sciences, Computer Science, Information Systems, or a related field. Advanced degrees or certifications in Project Management (PMP) or Life Sciences regulatory standards are preferred. Extensive Experience : 10+ years of experience in software implementation (SAAS -Preferred), with at least 5 years focused in the life sciences industry (pharmaceuticals, biotech, MedTech, etc.). Technical Expertise : Strong background in implementing SaaS platforms in regulated environments; experience with Regulatory systems/tools in Life Sciences or similar RIMS or regulatory platforms is highly desirable. Project Management Skills : Demonstrated expertise in project management and handling complex, high-stakes projects, using tools like JIRA, Asana, or MS Project. Regulatory Knowledge : In-depth understanding of life sciences regulations and standards, including FDA, EMA, and GxP requirements. Exceptional Communication and Negotiation Skills : Outstanding client-facing skills with the ability to convey complex technical information to a diverse audience. Problem-Solving & Adaptability : Skilled at troubleshooting and resolving client-specific challenges with a flexible, solutions-oriented approach. Preferred Qualifications: Previous experience with SAAS platforms in Life Sciences or equivalent regulatory and compliance platforms. Proven track record in leading system integrations, data migrations, or configuration management in SaaS environments. Experience working within an Agile framework and Linear Framework

Chemical Testing: Perform chemical test like FTIR, NMR, GC-MS, and titration to analyze the chemical composition of polymer Data Analysis, Sample Preparation Knowledge of statistical analysis technique quality management system, such as ISO 9001 Required Candidate profile Bachelor’s degree in chemistry, Polymer Science, Chemical Engineering Strong understanding of polymer chemistry and materials science We have 2 vacancies – 1 Male & 1 Female candidate.

Lead the design and development of innovative digital health products Oversee product lifecycle management from ideation to commercialization Collaborate with healthcare providers and tech teams to ensure compliance with medical regulations Must have experience in telemedicine, wearable tech, or AI-driven healthcare solutions Strong project management and UX design skills are required Knowledge of FDA and HIPAA regulations is a plus

Lead the design and development of innovative digital health products Oversee product lifecycle management from ideation to commercialization Collaborate with healthcare providers and tech teams to ensure compliance with medical regulations Must have experience in telemedicine, wearable tech, or AI-driven healthcare solutions Strong project management and UX design skills are required Knowledge of FDA and HIPAA regulations is a plus

Lead the design and development of innovative digital health products Oversee product lifecycle management from ideation to commercialization Collaborate with healthcare providers and tech teams to ensure compliance with medical regulations Must have experience in telemedicine, wearable tech, or AI-driven healthcare solutions Strong project management and UX design skills are required Knowledge of FDA and HIPAA regulations is a plus

Lead the design and development of innovative digital health products. Oversee product lifecycle management from ideation to commercialization. Collaborate with healthcare providers and tech teams to ensure compliance with medical regulations. Must have experience in telemedicine, wearable tech, or AI-driven healthcare solutions. Strong project management and UX design skills are required. Knowledge of FDA and HIPAA regulations is a plus.

Lead the design and development of innovative digital health products. Oversee product lifecycle management from ideation to commercialization. Collaborate with healthcare providers and tech teams to ensure compliance with medical regulations. Must have experience in telemedicine, wearable tech, or AI-driven healthcare solutions. Strong project management and UX design skills are required. Knowledge of FDA and HIPAA regulations is a plus.

Lead the design and development of innovative digital health products. Oversee product lifecycle management from ideation to commercialization. Collaborate with healthcare providers and tech teams to ensure compliance with medical regulations. Must have experience in telemedicine, wearable tech, or AI-driven healthcare solutions. Strong project management and UX design skills are required. Knowledge of FDA and HIPAA regulations is a plus.

Oversee the entire quality assurance process, from raw materials to finished goods, ensuring consistent quality & compliance, ensuring that products meet regulatory requirements & quality standards like ISO 13485, ISO 9001, 21 CFR 211 & 21 CFR 820 Required Candidate profile Bachelors in science 10-15 years' experience in quality in medical device/ pharma industry QMS implementation experience Must have regulatory audit exposure Like WHO/ USFDA & EU GMP

Job Title: Senior Manager- Logistics Department: Logistics / Supply Chain Management Location: Vashi / Head Office Reports To: Logistics Head Job Description: We are seeking a highly experienced and motivated Senior Manager Logistics to oversee end-to-end international trade operations, including import/export logistics , regulatory compliance , and banking documentation . The ideal candidate will bring a deep understanding of DGFT, CDSCO, Customs, and global trade regulations. Key Responsibilities: Manage import/export logistics for raw materials, capital goods, and high-seas trade. Handle customs clearance , DGFT documentation , MEIS/RODTEP claims, and AD Code registrations. Coordinate with CHA agents , ports (JNPT, Sahar), and international banks. Ensure timely and accurate filing with regulatory authorities (CDSCO, FDA, PHARMEXCIL, IMC). Liaise with DGFT, CDSCO, GST, MPCB, RBI, FEMA and other regulatory bodies . Attend hearings and manage legal responses (customs, GST, ED disputes). Work with banks for LCs , bill discounting, foreign payments, and remittance documentation. Collaborate with internal teams (Finance, Purchase, Admin, QA/RA) for smooth logistics operations. Ensure accuracy and timeliness in quarterly filings, license renewals, and logistics reporting. Candidate Profile Experience: 5-10 years in international logistics, import/export operations, and regulatory compliance. Knowledge of: DGFT, CDSCO, Customs, RBI/FEMA, GST, MEIS/RODTEP schemes. Tools: ERP systems, MS Office, ICEGATE, DGFT & CDSCO portals. Skills: Leadership, Coordination, Documentation, Negotiation, Communication. Why Join Us? Be part of a leading chemical & pharmaceutical organization . Engage in challenging, cross-functional international operations . Work in a compliance-driven and growth-oriented environment . Apply Now If you're passionate about managing logistics operations and working in a high-impact role apply on Naukri or send your resume to hrd@calyxindia.com and become a part of the Calyx growth journey!

Providing insights on industry and market developments, including policy and regulatory updates to advocate for favourable outcomes. Analysis of Regulations, Guidelines, Policies, Important order, etc. to derive meaningful insights & actionable for higher management. Support in Policy Advocacy, legal & regulatory on filing petitions with appropriate authority. Support in review of bidding, bid documents, RFS & PPA. Support in creation of Memorandums of Understanding (MOU) with government bodies, ensuring alignment with legal and strategic frameworks. Supporting business development and project expansion, ensuring alignment with ENGIEs strategy and objectives. Building positive relationships with stakeholders, associations, etc. through appropriate management of expectations and objectives, ensuring consistent and effective communication. Will handle the Invoicing, NFA, payment disbursement activities, etc. Draft representations, communication for various stakeholders. Additional Responsibilities: Supporting corporate communications efforts with different stakeholders. Monitoring key industry events and, ensuring ENGIEs participation at appropriate levels to enhance visibility and influence.

Lead the design and development of innovative digital health products. Oversee product lifecycle management from ideation to commercialization. Collaborate with healthcare providers and tech teams to ensure compliance with medical regulations. Must have experience in telemedicine, wearable tech, or AI-driven healthcare solutions. Strong project management and UX design skills are required. Knowledge of FDA and HIPAA regulations is a plus.

Lead the design and development of innovative digital health products. Oversee product lifecycle management from ideation to commercialization. Collaborate with healthcare providers and tech teams to ensure compliance with medical regulations. Must have experience in telemedicine, wearable tech, or AI-driven healthcare solutions. Strong project management and UX design skills are required. Knowledge of FDA and HIPAA regulations is a plus.

Job Title: FDA & International Pharma Compliance Consultant (Excipients, API & Ingredients & Formulations) Location: Kutch, Gujarat (Remote advisory with periodic on-site presence) Experience: 2025 years in pharmaceutical manufacturing and regulatory compliance Salary: Competitive Education: Bachelors or Master’s in Pharmacy, Pharmaceutical Sciences, Chemistry or related discipline Kindly get in touch for career advancement opportunities with us at rupsha.saha@antal.com Roles & Responsibilities Guide the upgrade and development of plant infrastructure and systems to achieve compliance with: WHO-GMP Regulatory requirements of Russia, Australia/New Zealand, African authorities Ultimate readiness for UK MHRA and US FDA audits Provide expert support on: WHO-GMP and GLP compliance for excipients, APIs, and formulation ingredients Equipment qualification (DQ/IQ/OQ/PQ) and cleanroom classification Process and cleaning validation Quality Management Systems (QMS), documentation (SOPs, BMRs, BPRs) and change control protocols Advise on regulatory documentation strategy for DMF and CTD/ACTD filings, including supplier qualification Assist in product selection and formulation pipeline development, identifying high-potential excipients and formulations for domestic and export markets Train and mentor QA, QC, production, and R&D teams on global pharmaceutical standards and best practices Desired Profile 20–25 years’ experience in excipients, API or formulations manufacturing, with a top-tier pharmaceutical company Proven track record of preparing and leading facilities through US FDA, MHRA or TGA audits Deep working knowledge of: ICH Q7/Q8/Q9/Q10 WHO GMP and EU GMP Annexes Indian D&C Act & Schedule M Hands-on experience supporting DMF submissions and familiarity with USP, EP, BP and IP Prior consulting or leadership roles serving regulated export markets Strong grasp of product lifecycle management, export documentation and quality risk management for emerging markets Tech-savvy, with exposure to digital QMS or e-BMR systems (desirable) Awareness of sustainability and EHS standards for global audit readiness Excellent cross-functional collaboration skills spanning production, QA/QC, R&D and supply-chain teams About Antal Antal International is a 30-year-old global executive search and placement firm with a network of over 800 people across 35+ countries, originally based out of the UK.

Role & responsibilities B.Pharma / M.Pharma candidates with 12--15years experience in Regulatory Affairs for Asia & Africa, CIS markets & ROW market wrt to Compilation of dossiers in CTD, eCTD & national ,Compilation and submission of queries and variations. Review of documents, artworks Review of change controls Gap analysis for variation filing and maintaining product Life cycle. Preferred candidate profile Reputed Pharma background

At Capgemini Invent, we believe difference drives change. As inventive transformation consultants, we blend our strategic, creative and scientific capabilities,collaborating closely with clients to deliver cutting-edge solutions. Join us to drive transformation tailored to our client's challenges of today and tomorrow.Informed and validated by science and data. Superpowered by creativity and design. All underpinned by technology created with purpose. The GxP CSV Validation Engineer ensures that digital systems used in clinical development comply with regulatory standards (GxP, 21 CFR Part 11, EMA Annex 11). They develop and execute validation protocols (IQ, OQ, PQ), risk assessments, and documentation to support system compliance and audits. The GxP CSV Validation Engineer ensures that digital systems used in Clinical, Regulatory Affairs, Medical Affairs, and PV Safety comply with GxP, 21 CFR Part 11, EMA Annex 11, and other regulatory standards. They develop and execute validation protocols (IQ, OQ, PQ), perform risk assessments, and maintain compliance documentation. Primary Skills Bachelors or Masters degree in Life Sciences, Computer Science, Regulatory Affairs, Quality Assurance, or a related field Certifications such as Certified Quality Auditor (CQA), GAMP 5, or CSV-related certifications are advantageous Skills (competencies)

Preferred candidate profile Year of experience : 4 - 6 yrs Must have exposure on Review of documents MFR, BMR, BPR, QC specification, process validation data, stability summary report. Having exposure in licensing, Knowledge of GMP & GDP. Candidate must have exposure in regulatory market. Interested candidate may share resume at hr.plant@zuventus.com

Develop and implement QA strategies and systems. Lead and mentor the QA team. Ensure compliance with regulations and standards like ISO. Drive process improvements, manage audits, collaborate with teams, maintain documentation.

We are looking for Quality Head, who has worked at least 10years in SGI Casting speciality in Manhole cover division. Maintain QMS, with computer knowledge. Job location-Howrah(WB),Salary-35k-45k Monthly. Walk in Interview. Contact : +91 7687919790

Total Experience: 5+ Years Relevant Experience: 5+ Years Job Description: We are seeking a skilled and detail-oriented Senior QA Engineer with a strong background in the banking domain and hands-on expertise in mobile banking application testing . The ideal candidate will have proven experience working with tools and frameworks such as Aperio , FDA , Inteflow , and Signature systems, and a solid command of test automation using Selenium with Java . Roles and Responsibilities: Conduct comprehensive testing for mobile banking applications , including Loans, Accounts, and Credit Card modules. Work with banking platforms and tools such as Signature , Aperio , FDA , and Inteflow . Collaborate with cross-functional teams in Agile/Scrum delivery models . Analyze and assess requirements to determine test scope, perform test estimations, and develop detailed test plans and scripts. Execute functional, regression, and automation tests while managing defects efficiently. Ensure adherence to quality assurance processes and best practices throughout the testing lifecycle . Utilize JIRA, Zephyr, and Confluence for test case management, reporting, and documentation. Apply strong version control and collaboration practices using Git and an understanding of branching strategies . Contribute to continuous test process improvements and help establish best practices in test automation and QA delivery. Mandatory Skills: Banking Domain Expertise : Signature, Aperio, FDA, Inteflow Automation Testing : Selenium with Java Strong understanding of Loans, Accounts, and Credit Card functionalities in banking Test Management Tools: JIRA, Zephyr, Confluence Agile Methodologies and Scrum Practices Git and branching strategies Nice to Have: Exposure to API testing and mobile automation frameworks ISTQB or equivalent certification

Hi, Wishes from GSN!!! Pleasure connecting with you!!! We been into Corporate Search Services for Identifying & Bringing in Stellar Talented Professionals for our reputed IT / Non-IT clients in India. We have been successfully providing results to various potential needs of our clients for the last 20 years. At present, one of our MNC client is hiring Computer System Validation Engineers. PFB the details for your better understanding : 1. WORK LOCATION : CHENNAI 2. Job Role: Engineer / Senior Engineer / Lead 3. EXPERIENCE : 7 to 12 yrs 4. CTC Range: Rs. 15 to 25 LPA 5. Work Type : WFO ****** Looking for SHORT JOINERS ****** Job Description : Min 4+ years of relevant EXP in COMPUTER SYSTEM VALIDATION is MUST, preferably in Life Science . EXP in process optimization in automated test environment. GOOD knowledge in software development life cycle ( SDLC ). EXP in serving as technical liaison between end users and testers. Proficient with 21 CFR Part 11, ICH guideline and FDA regulations on COMPUTER SYSTEM VALIDATION . Ensuring that the activities conducted are fully compliant with industry regulations and guidelines as required by ICH and FDA. Coordinating multiple validation and qualification activities with project teams, various departments and external vendors. System Testing, Regression testing; Backup and Restore; Disaster Recovery; Data Migration and upgrades introduced through change control. Conducting meetings for Risk Impact Assessments (RIA), Validation Risk Assessments and 21 CFR Part 11 Assessments. Creating User Requirements Specifications and assisting in the creation of a Functional Requirements Specification and the Technical Design Specification. Creating all System Delivery Life Cycle (SDLC) deliverables that are authored by Validation Engineer. Reviewing all System Delivery Life Cycle (SDLC) deliverables, providing constructive feedback, and ensuring that the deliverables adhere to associated Standard Operating Procedures (SOPs) or Working Procedures (WPs). Conduct and approve a Periodic Review of computer system validation documentation, including change control documentation, to ensure that the validated state of a system has been maintained over time. Create, update, and present training material associated with all aspects of the System Delivery Life Cycle (SDLC) and FDA regulations, such as 21 CFR Part 11 to client personnel. Representing Validation Services during sponsor audits and conducting external vendor audits. Focus on meeting project schedules, conducting System Delivery Lifecyle (and Agile SDLC), Validation. Thanks & Regards YOGI GSN CONSULTING 9840074801 Email : yogi@gsnhr.net; Web : www.gsnhr.net/https://g.co/kgs/UAsF9W

About The Role : Job TitleRegulatory Filtering Analyst, NCT LocationBangalore, India Role Description Regulatory Operations is responsible for defining and implementing procedures which provide regulatory operations services for various divisions of the bank and its group entities. This is to support the bank in its efforts to ensure regulatory compliance. Work includes: Partnering with the banks regulatory team to translate regulation into operational processes/procedures assisted Developing the banks information technology infrastructure Developing and implementing regulatory strategies, procedures and controls for new products and/or business activities that require governmental approvals Preparing and submitting regulatory applications such as permits, licenses, certificates and authorization required by governmental agencies Coordinating government interactions and compliance activities; and interacts with regulatory agencies What we'll offer you As part of our flexible scheme, here are just some of the benefits that youll enjoy Best in class leave policy Gender neutral parental leaves 100% reimbursement under childcare assistance benefit (gender neutral) Sponsorship for Industry relevant certifications and education Employee Assistance Program for you and your family members Comprehensive Hospitalization Insurance for you and your dependents Accident and Term life Insurance Complementary Health screening for 35 yrs. and above Your key responsibilities Support the RTB team lead in protecting DB from legal, regulatory and reputational risk with regard to business involving sanctioned entities and / or countries. Ensure diligent review and confirmation of transactions that require escalation to a Level 2 investigator and decide on these in full compliance with the applicable Sanctions regulations and the banks policies and procedures. Execute internal control checks as defined in the KOP documentation and Embargo control framework documents governed by AFC Sanction & Embargo. Support any applicable reporting obligations to the competent authorities with respect to transaction handling. Convert timely the update of the relevant embargo lists in respective filtering systems implement the data to central and decentralized tools in GT and Operations. Support CoC Regulatory Filtering team on the adoption of new clients Your Key Accountabilities RTB focus Primarily review stopped messages and take a decision on them (either pass or investigate), based on limited set of rules provided and maintained by AFC. Record rationale for decision from pre-defined set of options. Seek feedback from more senior investigators/reviewers, where their decisions fail the four-eye control. Provide support feedback loop and filter optimization by identifying repeat mismatches to propose Good Guys. Use user access privileges only for authorised purposes; actively safeguard sensitive and confidential information. CTB focus Supports TSMO / AFC related change projects Supports remediation actions owned by TSMO / AFC Training & Development Participate Trainings such as on HotScan, Sanctions policies, L1 procedures, specific payment types, including structure / form of messages. Your skills and experience Sanctions and Regulatory Filtering SWIFT Message Format and Fields SWIFT Payment Flow SEPA Message Structure and Payment Flow MS Office (MS Excel, Word and Outlook) Proficient in e mail communication Good communication skills (Written & Verbal) Ability to support rotational shifts Ready to support on weekends How we'll support you Training and development to help you excel in your career Coaching and support from experts in your team A culture of continuous learning to aid progression A range of flexible benefits that you can tailor to suit your needs About us and our teams Please visit our company website for further information: https://www.db.com/company/company.htm We strive for a culture in which we are empowered to excel together every day. This includes acting responsibly, thinking commercially, taking initiative and working collaboratively. Together we share and celebrate the successes of our people. Together we are Deutsche Bank Group. We welcome applications from all people and promote a positive, fair and inclusive work environment.

Roles and Responsibilities Manage regulatory affairs for domestic and international markets, ensuring compliance with FDA, ICH, EU regulations. Prepare dossiers for new product approvals, including artwork design and labeling requirements. Coordinate with cross-functional teams for formulation development, export documentation (DGFT), and licensing processes. Ensure legal metrology compliance by managing product registrations and maintaining accurate records. Provide guidance on regulatory matters to internal stakeholders and external partners. Handle regulatory documentation and submissions for Nutraceutical and Cosmetic products (domestic & export). Prepare dossiers, technical files, and product registrations as per domestic (FSSAI, CDSCO & Ect.) and international regulations. Ensure products comply with all legal and regulatory requirements of India and specific export markets. Regulatory handling and submission experience for Canada, USA, and European Union (EU) is mandatory. Review product labels, artworks, and marketing materials to ensure regulatory compliance. Liaison with internal departments (R&D, QC, QA, Marketing) for compiling regulatory documents. Maintain up-to-date knowledge of changing regulations in export markets. Desired Candidate Profile 2-10 years of experience in pharmaceutical industry with expertise in drug regulatory affairs. Bachelor's degree in Pharmacy (B.Pharma) or Master's degree (M.Pharma). Strong understanding of FSSAI guidelines and regulations governing food supplements/nutraceuticals.

Develop, implement, and maintain quality standards and inspection criteria for raw materials, in-process production, and finished products. Monitor production processes to ensure compliance with quality standards