“Established since 1999”
REGULATORY COMPLIANCE SERVICES
GCGI’s most requested Auditing, Training and Consulting Program that effectively combines auditing, workshop training and consulting follow-up activities for a complete learning experience and participants' success!
FAILURE INVESTIGATIONS AND QUALITY EVENTS are the first documents that the FDA Investigator takes into consideration when directing his/hers auditing strategy into specific system areas. This program allows your personnel to develop Regulatory Technical Writing Skills when documenting Quality Events in areas such as:
The program provides in-depth consulting and training activities in FDA REGULATORY TECHNICAL THINKING (RTT), REGULATORY TECHNICAL WRITING (RTW) and CAPA development/monitoring from an FDA Regulatory Perspective.
End results of the program allow companies to prevent FDA-483 objectionable observations, FDA Untitled Letters, FDA Warning Letters and other enforcement actions, including Injunction and Seizures.
A two/three-day workshop training course presented from an FDA Auditor perspective as it relates to current GMP regulations, laboratory/manufacturing events, non-conformances, Out-Of-Specifications (OOS) and Out-Of-Trends (OOT).
The course allows each participant to understand the basic elements of the process, “How FDA Thinks” when auditing your firm’s deviation system and the regulatory rationale behind the investigation process as well. Emphasis is given to procedures used for writing investigations taking into consideration the accuracy, integrity and security of data within a pharmaceutical, biotechnology and medical device operation.
To be effective, the workshop training emphasizes on situations or events already experienced by your personnel. Deviations are studied and used as a training tool to promote change during the identification of areas for improvement.
Please, feel free to browse or download our brochure which includes details about all aspects of the program.
Consulting & Coaching Activity
GCGI’s THREE-TIER PROGRAM™is available through online webinars. Consulting, auditing and coaching activities are presented live including individual and group discussions, workshop exercises and Q&A sessions.
Enjoy the full benefits of the program at considerably reduced rates when compared to on-site activities.
A SIX-MONTH “HANDS-ON” consulting and coaching activity conducted weekly or bi-weekly. This activity fine-tune participant's knowledge acquired during TIER-TWO so that he/she becomes proficient documenting Manufacturing Quality Events, Laboratory Failure Investigations and Corrective and Preventive Action (CAPA) plans.
Personnel will receive a ONE-TO-ONE coaching service enabling them to apply Root-Cause-Analysis (RCA) and Problem-Solving Tools (PST) in Manufacturing and Laboratory events within an “FDA -THINKING” systematic structured approach.
The service involves the evaluation of in-process and/or completed manufacturing/laboratory investigations including CAPA development and monitoring activities.
Consulting, Auditing and Coaching activities include the following:
Learn How To Think Like The FDA ®