Certificate Program in Clinical Trials Auditing & InspectionCliniminds
Frequent Asked Questions
All working professionals from the clinical research and pharma industry; investigators & site personnel and MD, MS, MBBS, BDS, BHMS, BAMS, BUMS, BPT, B.Pharma, Graduate/Post Graduate Degree in Life Sciences, Pharmacology, Pharmacy, Nursing, Biochemistry, Microbiology, and biotechnology students.
Auditing and Inspections in Clinical Trials is a program specifically designed for those involved in preparing for and overseeing GCP inspections and those responsible for quality assurance and auditing in the industry. The program has also been designed for the professionals who have just entered in the field of clinical research, or would like to build career in the domain of quality assurance or clinical research.
The course has been outlined in the following sequence:
Module 1 - Introduction to QC, QA & Audits
Chapter - 1 Introduction to Quality in Clinical Research
Chapter - 2 Process Mapping in Clinical trials
Chapter - 3 QA and QC in Clinical Research
Chapter - 4 Practical exercises and Interactive sessions- Designing a process Map etc Chapter - 5 Tools of Audits
Chapter - 6 Auditors -Who and What are they?
Chapter - 7 Preparing for an Audit
Chapter - 8 Conduct of an Audit
Chapter - 9 CRO Audit
Chapter - 10 Practical Case Scenarios in Audits
Module II - Regulatory Inspections
Chapter - 11 FDA Inspections- Preparation, Conduct, Reporting and Recording of Inspections Chapter - 12 EMEA Inspections- Preparation, Conduct, Reporting of Inspections
Chapter - 13 MHRA Inspections- Preparation, Conduct, Reporting of Inspections
Chapter - 14 ANVISA Inspections
Chapter - 15 IEC/IRB Inspections
Chapter - 16 DCGI Inspections
Chapter - 17 Conduct of a Mock inspection
Chapter - 18 Differences between FDA and EMEA Inspections
Chapter - 19 Frauds, Misconduct and Errors Chapter - 20 Practical Scenarios in Regulatory Inspections
Upon completion of the program, students would be able to understand the basics concept of quality assurance in clinical trials; process and implications of Audits & Regulatory inspections and the issue of Frauds and misconduct. The program is practical in nature and students would be able to apply the knowledge in the work environment as well.