FDA-oRIENTED​

​“Established since 1999”

Quality Event

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. 

CERTIFICATION

​Evaluation of Investigation Reports

©2016, GCGI - QESE Medal Seal, "All Rights Reserved". 

APPROACH

Quality Events

Certification Program

Certification Modules:

​​MODULE 1:​

MODULE 2:

MODULE 3: 

Solutions Expert™

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. ​

Are you ready to become a leader as a Compliance Investigator Professional?

​​​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.

Get Certified Now.

​​​​​GUERRA

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 ®

PROGRAM

DETAILS

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!

consultinggroup,inc.™

​​​Regulatory Issues and Quality Events

​Documenting Quality Events: The Investigation Report​

GCGI's Quality Events Certification Program ™

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.