FDA-oRIENTED​

​“Established since 1999”

​​​​​GUERRA

consultinggroup,inc.™

REGULATORY COMPLIANCE SERVICES

Workshop Training


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:

  • Manufacturing and Laboratory Operations.
  • Data Integrity, Computer Systems Validation (CSV) and Part 11.
  • Process and Analytical Method Validations.
  • Instrumentation, PM and Calibration Programs.
  • Facilities, Engineering and Utilities areas.
  • Vendors and suppliers.


​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. 


Ready to devel­op new skills and abilities allowing the early detec­tion, correc­tion and pre­vention of quality events that other­wise would end as FDA Warning Letters? 


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. 

  • Obtain a complete Assessment of Failure Investigations and Quality Event procedures for any FDA regulatory vulnerability.
  • Avoid FDA-483s objectionable observations based on inadequate procedures.
  • Avoid documentation inconsistencies.
  • Detect, correct and prevent voluntary and careless-work type of human errors.
  • Maintain scientific, robust and compliant procedures in place at the Corporate, Region and Local levels.
  • Understand FDA’s thinking and rationale when documenting Quality Events.
  • Learn how to emulate FDA’s Investigator thinking and auditing approach when documenting a deviation or quality event.
  • Learn how to document a deviation in terms of impact to product quality.
  • Learn how to document a deviation related to Consumer Complaints.
  • Learn Root-Cause-Analysis (RCA) and apply Problem-Solving Techniques (PST) in any area.
  • Be able to detect, correct, prevent and predict failures/deviations and quality events.
  • Learn to develop effective Corrective and Preventive Action Plans (CAPAs).
  • Obtain a ONE-TO-ONE consulting service and apply the “FDA-Thinking” when documenting Quality Events.
  • Develop REGULATORY TECHNICAL WRITING (RTW) skills.
  • Correct and prevent situations in areas that might be prone to quality events.
  • Correlate deviations with equipments’ validated state to maintain qualification status.
  • Monitor status of validated pharmaceutical systems.
  • Decrease amount of time required to document a deviation.
  • Make wise “Quality Risk Management” decisions and avoid regulatory penalties!
  • Be able to detect and prevent mix-ups, mix-labels and short-fills.
  • Improve Line Clearance procedures.
  • Detect system failure and deviations that could end as FDA-483s, Untitled and Warning Letters.

Consulting & Coaching Activity 

GCGI's THREE-TIER PROGRAM in FAILURE INVESTIGATIONS ™

  • Evalua­tion of firm’s regu­la­tory com­pli­ance on no­tifi­ca­tion of events (NOE), non-con­for­mances, quality events, and fail­ure in­vesti­ga­tions in manu­fac­tur­ing and labo­ra­tory operations.
  • Plan­ning stage for in­vesti­ga­tions in­clud­ing Qual­ity Risk Man­age­ment As­sess­ment.
  • Evalua­tion of pro­ce­dures used in the de­vel­op­ment of In­vesti­ga­tion Re­ports.
  • As­sess­ment of docu­ments and com­pli­ance check­lists.
  • Ad­vise on al­ter­na­tives for NOEs and de­via­tions.
  • Evalua­tion and con­sult­ing on FDA au­dit re­ports in­clud­ing FDA-483 items.
  • Evalua­tion and con­sult­ing on in­vesti­ga­tions re­lated to Con­sumer Com­plaints, Field Alert Re­ports, An­nual Prod­uct Re­views, Prod­uct Re­calls and oth­ers.
  • Evalua­tion and con­sult­ing on Cor­rec­tive and Pre­ven­tive Ac­tion Plan (CAPA) docu­ments.

​Audit­ing ac­tivity 

Program Benefits

THREE-TIER

Program

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:

  • Plan­ning stage for the investi­ga­tions.
  • Evalua­tion of quality events and failure in­vesti­ga­tions per CGMP re­quire­ments in manu­factur­ing and labo­ratory operations. A quality event evaluation form is used to track and trend per­sonnel pro­gress to en­sure a con­tinuous learn­ing proc­ess.
  • Coaching per­sonnel in TECHNI­CAL THINK­ING and FDA TECHNICAL WRITING prior to or af­ter the write-up of the in­vesti­ga­tion report.
  • In-depth consulting and coaching in Root-Cause-Analy­sis (RCA) and Prob­lem-Solv­ing Tech­niques (PST). 
  • Evalua­tion of sys­tems af­fected based on the out­come of in­vesti­ga­tions.
  • Teaching Qual­ity Man­age­ment Risk As­sess­ment tech­niques.

Learn How To Think Like The FDA ®