GCP Training
Instructor
Christina Sanchez Miller, MPH | Biotech Research Group
Bio:
Christina has over 20 years of management, biologics, quality assurance and research experience in the medical field. She is a published author in scientific books, papers and has presented at several international conferences. Christina has developed medical applications in the biologics field. She has assisted foreign health departments in writing legislation and working with clients in over 60 countries with licensures and permitting. Her experience includes operations and consulting in FDA Adverse Event Reporting, FDA Product Deviation Reporting, FDA 483’s, cGTP’s, infection control, certified ISO Class 5, 7, 8 development and maintenance, QIC and auditing all facility types including clinical trials.
Certificate
All participants who successfully complete the course will receive a Certificate of Completion in “Current Good Clinical Practices,” a valuable and required credential for employers and regulatory agencies.
Objective
During this Live Online Training Course, a subject matter expert will share their expert knowledge about important aspects of IMP Supplies and the Management of Clinical Trials. Hear essential aspects about the organization and management of the supplies, detection and reporting of adverse events, things to consider during the study and learn how the various regulations lead the way.
Background
In the development of new pharmaceutical products, it is a challenge to design and initiate sound and appropriate studies. FDA compliance with current Good Clinical Practices regulations is mandatory. A prerequisite for a successful study is having the required knowledge of FDA regulations, current Good Clinical Practices and protocol requirements. GCP requirements need to be considered and understood from all parties involved.
This Live Online Training Course has been designed by AAQF to provide useful information which is needed for an efficient management of clinical Trials.
Target Group
► Managers and executives from R&D dealing with clinical trial management
► CRO staff
► Clinical Research Coordinators
► Regulatory Affairs Managers and Coordinators
► Data Entry Managers and Coordinators
► Pharmacy Managers and Technicians
► Laboratory Managers and Technicians
► Recruitment Managers and Coordinators
Technical Requirements
AAQF uses Zoom for our live online training courses and webinars. After successful registration, you will receive a link with all the Information you need to participate in AAQF trainings, and you can check if your system meets the necessary requirements to participate. Zoom can be accessed by their application or by any browser (Google Chrome works best). Zoom is a standard method for training and is fast and easy to access.
Program
Day 1
Session 1 (0900-1200)
► ICH E6 GCP Guidelines
► FDA 21 CFR Parts 50 and 56
► Roles and responsibilities: Sponsor, CRA, Investigator
► Sponsor: Achieving and Maintaining the Blind
► IND Application
► IDE Application
► Investigator’s Brochure
► FDA 1572 Form
► Institutional Review Board
► Delegation of Authority
► Questions & Answers
Break (1200-1215)
Session 2 (1215-1515)
► Oversight of Clinical Trials
► Personnel Training
► Protocol Compliance
► Source Documentation
► Recruitment
► Subject Eligibility
► Informed Consent
► Vulnerable Subjects
► Data Integrity
► Electronic Data Capture
► Vendors and contractors of electronic systems
► Subject Visits
► Questions & Answers
Day 2
Session 1 (0900-1200)
► Labeling IMPs
► Packaging IMPs
► Shipping IMPs
► Storing IMPs
► Significant risk vs non-significant risk devices
► IMP Preparing & Dispensing
► Accountability and Reconciliation
► IRT
► Temperature deviations
► IMP return and destruction
► Questions & Answers
Break (1200-1215)
Session 2 (1215-1515)
► Classifying Adverse Events
► Detection of Adverse Events
► Evaluation of Adverse Events
► Reporting Serious Adverse Events
► Facilities & Equipment
► Regulatory Affairs & Quality Assurance
► Monitoring Visits
► FDA Inspections
► Storage & Destruction of Study Documents
► Questions & Answers