Audits: Raaj GPRAC provides a multitude of training services through audits as well. The audit exercises include compliance assessment and advisory activities at clients offices and premises. Our audits include the following: A. Regulatory Compliance Audits and ISO Certification: We assist clients to prepare for an imminent regulatory inspection by carrying out one or more mock regulatory audits in advance of the real thing. Our consultants visit the facility and carry out an inspection in the style of the relevant regulatory body (Local (Indian) FDA, US-FDA, MHRA, EMEA etc.) after which we will provide An in-depth, impartial and professional assessment of their current state of compliance.A detailed, prioritized action plan for the rectification of areas of non-compliance and vulnerability.Staff coaching in the sorts of questions which are likely to be asked during the inspection and how best to answer them.GMP Gap analysis auditWe visit the client site and perform an audit to determine where one needs to improve processes, documentation, and operations. We have experienced people able to perform GMP Audit Readiness/GMP GAP assessments for the clients facility against GMP requirements. We also offer assistance in correcting any deficiencies found. B. Good Clinical Practice (GCP) Audits 1. Adequacy of Systems / System AuditsA birds eye view of the system to assess major process gaps and select the key systems impacted in the fields of Clinical Research, Quality Assurance and Pharmacovigilance for Phase I to IV studies.Looking into the adequacy of the Standard Operating Procedures with respect to regulatory requirements and suggestion for new SOPs.Vendor management SOPs and frequent quality checks of the vendors.2. Investigator site and sponsor/CRO file auditsAudit Plan development based on risk assessment of the study and the site performanceConduct a detailed review of all essential documents related to study conduct for the selected sites for audit preparationConduct Investigator site auditPrepare and send audit reports (one per site) to clinical research team.Training We provide in-depth training and workshops on the courses and programs that are at par with the current trends of the pharmaceutical industry. Our courses and programs are designed to leverage your career options and hone your expertise in the various aspects related to the pharmaceutical industry. We conduct Training and Workshops on RA/ QA/ AD/ FD/ ICH/ CTD/ eCTD/ ACTD/ 21CFR parts/ GMP/ GLP/ GCP, with Case Studies, Exercises, Questionnaires. The following are the major highlights of our workshops and training programs:Dedicated and comprehensive guidance and counseling of Pharmacy studentsTraining and Development of Pharmacists, RA, QA, Clinical AssociatesGrooming and mentoring future leaders in Pharmaceutical industrys various aspects like RA, QA and RDComplete support in successful audit preparation for WHO-GMP, USFDA, UK-MHRA and the like.Technical Support in helping students understand the logistics and ground realities of DCGI FDA activitiesSupport in Clinical SubmissionsGMP CGMP training to workmen, operators, and supervisory staffFDA GMP centric training courses materialsGMP Training Program modules on topics such as Good Documentation Practices, cGMP Basics and cGMP Advance that you can use for your ongoing training needs.Onsite or Classroom training to Pharmaceutical, Biotech industries, and Food industries to Officers, Executives, Managerial staff from Production, Warehousing, QA, QC and Marketing followed by evaluation.