“Established since 1999”
The Certification Program consists of three (3) modules. Each module is delivered monthly. Six (6) hour weekly discussions are held at participant's company and/or presented via web. GCGI uses Cisco WebEx® Event Center, a web conferencing application enabling full audio/visual video multi-person meetings and classes.
Evaluation of Investigation Reports
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GCGI’s QUALITY EVENTS CERTIFICATION PROGRAM™ is available through online webinars. Training activities are presented live including individual and group discussions, workshop exercises and Q&A sessions.
Typically, organizations direct their improvement efforts to a plethora of initiatives including Total Quality Management (TQM), Lean Manufacturing, Lean Service, Kaizen (Continuous Improvement), Variation Reduction, Business Process Reengineering, and others without fully integrating the regulatory compliance aspect on such activities.
Inevitably, such efforts have been questioned by FDA Officials whenever the “Lean” concept is being brought as an improvement tool impacting product quality or the potential impact to facilities, equipment, processes, controls, products, employee practices or records.
In a public speaking forum, the FDA has cautioned companies not to become “ANOREXIC” (extremely thin) when implementing Process Excellence activities since FDA-483s and Warning Letters have resulted when no provisions have been taken during the implementation of process improvement tools.
GCGI’s approach to Process Excellence (PE) is based upon the certification of personnel in Regulatory Compliance Practices, Documentation of Quality Events and Failure Investigations, Problem-Solving Tools/ Root-Cause Analysis, an ultimately, the certification as CAPA SPECIALISTS that would emulate the FDA INVESTIGATOR in all aspects of pharmaceutical operations. This individual would become a “Quality Event Solutions Expert (QESE) ™” able to interact with all Process Excellence initiatives the company is willing to implement. With a strong background in Regulatory Compliance Operations, including the awareness of potential quality and regulatory problems, the QESE will be able to evaluate processes and systems in terms of how effectively and efficiently they create value to the company.
Excellent processes are those that are both effective and efficient while maintaining the right balance between regulatory and business needs. The Certification Program in Quality Events allows personnel to adequately interact with process enhancements and improvement activities preventing the extreme “Leaning” or “ANOREXIC” effect that has been defined by the FDA in public speaking forums. The program is geared toward the correction and prevention of events that may have a direct or potential impact to product quality that otherwise could end as a regulatory sanction impacting negatively all PE initiatives and the business side of the company as well.
GCGI’S Quality Events Certification Program ™ provides process excellence mechanisms to direct toward the organization’s goal of improving competitive advantage, securing the best employees, delivering superior customer value, and earning a premium return for its investors.
The Three-month (72 hours) Certification Program in Quality Events focuses in a “LEARN-BY-DOING”educational approach. The program emphasizes on extensive exercises, individual and/or group discussions, homework, certifications exams and continuous interactive learning experience geared toward the correction and prevention of quality events and ultimately; "How to Think and Emulate the FDA Investigator".
Certified individuals become Quality Event Solutions Expert (QESE) ™ enabling them to be in the forefront of Process Excellence (PE) initiatives evaluating processes and systems in terms of how effectively and efficiently they create value to the company.
The training methodology involves presentations, discussion and exercises of manufacturing and laboratory quality event investigations as well as the evaluation and discussion of exam results. The program is delivered either on-site, via web or a combination of both.
Learn How To Think Like The FDA ®
To be certified as a QESE reflects professional achievement beyond the basic level of knowledge required for current job functions.
QESE certification validates your qualifications as a professional and advance competency by gaining instant professional credibility.
Best of all, you stand out as the EXPERT in the Regulatory and Technical Investigations field!
Regulatory Issues and Quality Events
Documenting Quality Events: The Investigation Report
REGULATORY COMPLIANCE SERVICES
GCGI’s Quality Events Certification Program ™ is an approach for Process and Business excellence emphasizing on Regulatory Compliance as the main driver to improve business operations.