Fda training

Institute of Good Clinical Practice (iGCP) offers different unique programs for aspiring professionals willing to pursue a career in Clinical Research, Clinical Data Management,CDISC-SDTM, and SAS. The training program aims to provide a career path for professionals from Life Sciences and Statistics background. Highly experienced staffs from clinical research and data management industry trains students with hands on experience on various areas in clinical research, Clinical Data Management, CDISC-SDTM, SAS, Pharmacovigilance,Drug regulatory affairs, Table Listings Figures (TLF’S)etc. Institute of Good Clinical Practice (iGCP) provide training in three different modes like Class Room, Online-learning for all Medical, Pharmacy and Science students and professionals aspiring to make a career in Clinical Research. Technical learning's: Extensive knowledge of drug safety and drug development process and procedures In-depth knowledge of coding principles, submission criteria, regulatory timeline requirements, technical requirements and guidelines Extensive knowledge of US and ICH safety reporting regulations and guidelines. Good understanding of IND safety reports, 21 CFR part 11 and HIPPA guidelines. Performed triage, evaluation and processing of adverse event reports from post marketing and clinical sources in accordance with FDA and ICH guidelines Working knowledge pertaining to MedDRA and WHO Drug dictionaries. Proficient in data entry and excellent knowledge of ARGUS safety database. Eligibility: Bachelor's, Master’s, or PhD, MBBS/ MD/B.D.S /M.D.S/ B.A.M.S / B.H.M.S /B.P.T/ B.Tech (Biotechnology / Pharmaceutical Science) / B. Pharm /M.Pharm /BVSC / B.Sc. (Nursing) / B.Sc./M.Sc, M.Pharmacy, M.Sc /MA (Statistics) and all professionals working with Pharmaceutical companies, CROs and Hospital.

COVALENT:- Covalent is a group of company which has services and operations in Clinical, Information Technology, Energy, consumer products, Power and Infrastructure. Training @ Covalent:- We arededicated to establish ourselves as ''A values-driven organization''. These values will continue to direct our growth and organization’s operation. “Covalent” values supporting the way like “Kreative”. Regulatory Affairs(RA) Training or Course:- Introduction to different types of Pharmaceutical products: Basic concepts on Rx, OTC, API, Starting material, DP/FP, Generics vs. Innovator drugs, Biologics vs. Biosimilars, Laws vs. Regulations vs. guidelines. Drug discovery and development Worldwide regulatory agencies and their role Approval process for each of the below products in US/EU/India: [covers development path, submissions, regulatory expectation for development, approval and market] Post-market regulatory obligations GLP’s: 21 CFR 58 -The History of GLP, The Idea behind GLP, The Areas of Application, The Pillars of Good Laboratory Practice, Where Can GLP be Profitably Applied?, Indian GLP and International GLP. CMC topics: GMP (US/EU/Indian/ PIC), Preformulation studies (Drugs and Generics), ICH Q 7 guideline, 21 CFR 210 and 211, Medical device CE marking and ISO certifications. Audits, pre and post approval Inspections, handling post inspection/ audit queries. Collecting, organizing and compiling various regulatory submissions in compliance with the applicable regulations: ASEAN and BRIC regulations and registration process of Drugs and Biologics. Different stages of interactions, briefing packages, responses and corrective measures during drug approval process with FDA. PDUFA meetings and advisory committee meetings with US FDA, EU scientific advisory committee. Regulations of Drugs and cosmetics Act, and its importance to Indian pharma industry. Recent regulatory changes in Indian DCGI and compiling dossiers for various DCGI submission: Hands on workshops in next 15 days: Word template of CTD structure. Hands on work of filling different regulatory forms in US/EU/India. Preparing for Regulatory interviews (Example interview questions will be provided). Communication skills. 2-3 seminars each of individual students to enhance their confidence and presentation skills. Explaining the real difficulties faced in a pharma industry and providing Corrective and Preventive Actions (CAPA). Training Duration (Classroom/Online): 3-Months/2-Months Training Fee: 20K/25k + Taxes Mobile: Website:- http://covalentech.com/regulatory_affairs.html

Institute of Good Clinical Practice (iGCP) offers different unique programs for aspiring professionals willing to pursue a career in Clinical Research, Clinical Data Management,CDISC-SDTM, and SAS. The training program aims to provide a career path for professionals from Life Sciences and Statistics background. Highly experienced staffs from clinical research and data management industry trains students with hands on experience on various areas in clinical research, Clinical Data Management, CDISC-SDTM, SAS, Pharmacovigilance,Drug regulatory affairs, Table Listings Figures (TLF’S)etc. Institute of Good Clinical Practice (iGCP) provide training in three different modes like Class Room, Online-learning for all Medical, Pharmacy and Science students and professionals aspiring to make a career in Clinical Research. Technical learning's: Extensive knowledge of drug safety and drug development process and procedures In-depth knowledge of coding principles, submission criteria, regulatory timeline requirements, technical requirements and guidelines Extensive knowledge of US and ICH safety reporting regulations and guidelines. Good understanding of IND safety reports, 21 CFR part 11 and HIPPA guidelines. Performed triage, evaluation and processing of adverse event reports from post marketing and clinical sources in accordance with FDA and ICH guidelines Working knowledge pertaining to MedDRA and WHO Drug dictionaries. Proficient in data entry and excellent knowledge of ARGUS safety database. Eligibility: Bachelor's, Master’s, or PhD, MBBS/ MD/B.D.S /M.D.S/ B.A.M.S / B.H.M.S /B.P.T/ B.Tech (Biotechnology / Pharmaceutical Science) / B. Pharm /M.Pharm /BVSC / B.Sc. (Nursing) / B.Sc./M.Sc, M.Pharmacy, M.Sc /MA (Statistics) and all professionals working with Pharmaceutical companies, CROs and Hospital. ADDRESS: INSTITUTE OF GOOD CLINICAL PRACTICE, # 2ND FLOOR,ABOVE MORE SUPER MARKET, NEAR SRIPURAM COLONY BUS STOP, MOOSARAMBAGH, MALAKPET, HYDERABAD. PH:,, 040 .

Institute of Good Clinical Practice (iGCP) offers different unique programs for aspiring professionals willing to pursue a career in Clinical Research, Clinical Data Management,CDISC-SDTM, and SAS. The training program aims to provide a career path for professionals from Life Sciences and Statistics background. Highly experienced staffs from clinical research and data management industry trains studentswith hands on experience on various areas in clinical research, Clinical Data Management, CDISC-SDTM,SAS, Pharmacovigilance,Drug regulatory affairs, Table Listings Figures (TLF’S)etc. Institute of Good Clinical Practice (iGCP) provide training in three different modes like Class Room,Online-learning for all Medical, Pharmacy and Science students and professionals aspiring to make a career in Clinical Research. Technical learning's: Extensive knowledge of drug safety and drug development process and procedures In-depth knowledge of coding principles, submission criteria, regulatory timeline requirements, technical requirements and guidelines Extensive knowledge of US and ICH safety reporting regulations and guidelines. Good understanding of IND safety reports, 21 CFR part 11 and HIPPA guidelines. Performed triage, evaluation and processing of adverse event reports from post marketing and clinical sources in accordance with FDA and ICH guidelines Working knowledge pertaining to MedDRA and WHO Drug dictionaries. Proficient in data entry and excellent knowledge of ARGUS safety database. Eligibility: Bachelor's, Master’s, or PhD, MBBS/ MD/B.D.S /M.D.S/ B.A.M.S / B.H.M.S/B.P.T/ B.Tech (Biotechnology / Pharmaceutical Science) / B. Pharm /M.Pharm /BVSC / B.Sc. (Nursing) / B.Sc./M.Sc, M.Pharmacy, M.Sc /MA (Statistics) and all professionals working with Pharmaceutical companies, CROs and Hospital. MAIL ID: WEBSITE: www.igcp.co.in FOR ONLINE TIMINGS: PM TO PM FOR CLASS ROOM TIMINGS: AM TO PM ADDRESS: INSTITUTE OF GOOD CLINICAL PRACTICE, # 2ND FLOOR,ABOVE MORE SUPER MARKET, NEAR SRIPURAM COLONY BUS STOP, MOOSARAMBAGH, MALAKPET, HYDERABAD. PH:,, 040 .

Institute of Good Clinical Practice (iGCP) offers different unique programs for aspiring professionals willing to pursue a career in Clinical Research, Clinical Data Management,CDISC-SDTM, and SAS. The training program aims to provide a career path for professionals from Life Sciences and Statistics background. Highly experienced staffs from clinical research and data management industry trains students with hands on experience on various areas in clinical research, Clinical Data Management, CDISC-SDTM, SAS, Pharmacovigilance,Drug regulatory affairs, Table Listings Figures (TLF’S)etc. Institute of Good Clinical Practice (iGCP) provide training in three different modes like Class Room, Online-learning for all Medical, Pharmacy and Science students and professionals aspiring to make a career in Clinical Research. Technical learning's: Extensive knowledge of drug safety and drug development process and procedures In-depth knowledge of coding principles, submission criteria, regulatory timeline requirements, technical requirements and guidelines Extensive knowledge of US and ICH safety reporting regulations and guidelines. Good understanding of IND safety reports, 21 CFR part 11 and HIPPA guidelines. Performed triage, evaluation and processing of adverse event reports from post marketing and clinical sources in accordance with FDA and ICH guidelines Working knowledge pertaining to MedDRA and WHO Drug dictionaries. Proficient in data entry and excellent knowledge of ARGUS safety database. Eligibility: Bachelor's, Master’s, or PhD, MBBS/ MD/B.D.S /M.D.S/ B.A.M.S / B.H.M.S /B.P.T/ B.Tech (Biotechnology / Pharmaceutical Science) / B. Pharm /M.Pharm /BVSC / B.Sc. (Nursing) / B.Sc./M.Sc, M.Pharmacy, M.Sc /MA (Statistics) and all professionals working with Pharmaceutical companies, CROs and Hospital. FOR ONLINE TIMINGS: PM TO PM FOR CLASS ROOM TIMINGS: AM TO PM ADDRESS: INSTITUTE OF GOOD CLINICAL PRACTICE, # 2ND FLOOR,ABOVE MORE SUPER MARKET, NEAR SRIPURAM COLONY BUS STOP, MOOSARAMBAGH, MALAKPET, HYDERABAD. PH:,, 040 .

Introduction: A Course designed to completely engage you in Computer system Validation for the present Needs. This Course delivers Hands on experience knowledge on how CSV is treated and looked at in the present times. You will be ready for how to select the right validations and right controls (Technical and Procedural) Know how on handling PLC's. Challenges: Data Integrity with Documentation Identifying right and appropriate Procedural and Technical controls How Agile methodology works for Cat 5 development Learning Objectives: Role of FDA CSV Points and why Validate GAMP Relation between 21 CFR Part 11, Annex 11 and 211 Risk Assessments Data Integrity CSV Deliverables (Technical and Procedural controls) How to have an SOP and benefits and following the SOP's Compliance Challenges: The confusion due to what are often contrary interpretations of CSV requirements, the focus on generating extensive CSV packages, and fear of not meeting regulatory expectations turn many CSV projects into major endeavors that lose sight of the contribution to quality and compliance. A harmonized and consistent risk-based CSV is an effective way to optimize the investment allocated to corporate compliance programs. Target Audience: A must attend the seminar for professionals in Pharmaceuticals, QC Laboratories, APIs, Finished Products, Contract Laboratories, CROs, Medical Device & Biotech companies, and Suppliers of Computer Systems. DEPARTMENTS: Quality Control & Quality Assurance, Research and Development, Laboratory and Regulatory Compliance, IT/IS & Software Departments, Production & Manufacturing, Documentation, Training Departments PROFESSIONALS: Managers and Supervisors, Senior Managers and Team Leaders, General Managers, Analytical Chemists, Validation Specialists, Laboratory Managers and Supervisors, Regulatory Affairs Managers, Documentation Specialists & Analysts, Consultants, and Systems Administrators