Make sure to check out our current schedule by accessing our calendar. Please book your session in advance. Sessions are added regularly, so check back often to keep updated.
Johnny Guerra experience and expertise in developing technical and regulatory training programs as well as consulting, auditing and validation activities is recognized worldwide. This former FDA official has refined training skills conducted on hundreds of courses and seminars during 42 Years of Industry, Agency and Consulting service by training more than 75,000 individuals worldwide since 1979.
"GCGI improved employees' performance while decreasing errors. It just pay-off for the training itself during the first few days after the training has concluded! Employees have been trained to act as our own INTERNAL REGULATORY CONSULTANTS! ...Thanks again."
All training sessions are available via web. GCGI uses Cisco WebEx® Event Center, a web conferencing application enabling full audio/visual video multi-person meetings and classes. Virtual classes are presented live including group discussions, exercises and Q&A sessions. Web courses are provided on demand and customized to meet your teams’ training and scheduling needs.
Guerra’s "chalk and talk" teaching method consists of spaced learning (changing from MS PowerPoint® lectures to "chalk") and interactive participants’ engagements. All annotations are saved in PDF and sent to participants at the conclusion of the course. Participants refer back to these notes and apply concepts to the solution of cGMP issues, quality events and CAPAs.
“Established since 1999”
GCGI provides technical and FDA-regulatory courses designed to meet your needs in Quality and Compliance related activities. All courses are developed and presented by Johnny Guerra, a FORMER FDA OFFICIAL with vast regulatory and practical technical experience for specific job functions, providing training that meets industry and regulatory goals from Pharmaceutical, Biotechnology, Discovery Work, R&D and Medical Device companies.
Johnny Guerra has trained FDA’s INVESTIGATORS, INSPECTORS, CHEMISTS AND MICROBIOLOGISTS in regulatory compliance auditing techniques. Guerra’s presentations are UNIQUE since they address the FDA REGULATORY COMPLIANCE perspective by teaching participants how to emulate and “THINK” like the FDA INVESTIGATOR at their working areas. Guerra’s commitment is to teach all participants “How To Think…Like The FDA".® All training sessions are delivered under complete confidentiality. Recommendations are performed on an individualized basis per questions being asked and provided specifically for the practical solution of each problem discussed during the training activity. GCGI designs and/or modify any course to meet your company’s training needs. To be effective, training courses emphasize on situations or events already experienced by your personnel.
As anauthorized and certified Cisco WebEx® System Administrator, Guerra not only presents topics but has complete control of WebEx audio/video tools including digital pens and color markers displayed directly on a graphic tablet screen with a pressure-sensitive pen.
You can join the training session right from your iPhone, iPad, Android tablet, smartphone, or connect a desktop/laptop computer to an audio/ video projector for a formal conference setting. Telephone line audio, integrated VoIP audio and web conferencing on Wi-Fi and 3G/4G allows worldwide personnel to attend and interact with the training session.
“Mr. Guerra has a lot of experience and many real company experiences and examples to pass on. He possesses the qualities all instructors should be required to have.”
Guerra is well known for his teaching ability of adding and enhancing concepts with the use of chalk and whiteboards. Since 2007, this skill has been transferred and mastered in the digital web medium and virtual classroom.
"Dear Mr. Guerra:
I found that your presentation on Data Integrity in Laboratory Operations was one of the most engaging that I have ever had the privilege to listen to, and found myself captivated by every word. The amount of attention you gave to the future needs of our company was very educational, and persuasive. I offer my thanks for taking the time to talk to us, and I hope to see you back soon presenting technical and regulatory courses."
Category 1: Human Error, Quality Events & Process/Business Excellence
Category 2: Meeting FDA & GMP Requirements
Category 3: Analytical Laboratory
Category 4: Equipment Qualifications
Category 5: Computer System Validation (CSV)
Category 6: Electronic Records; Electronic Signatures (21 CFR 11)
Active employee participation is key to a successful virtual classroom training experience.
Guerra'straining activities engage employees and prompt them to think about how the subject matter relates to their own work. Workshop exercises trigger participants' engagement throughout the duration of the virtual training. Typical problems are addressed and solutions furthermore provided.
For group settings, a “Test Run” is included prior to the training session. This activity ensures that audio/video connections are adequate and that there aren't any glitches that can hinder the overall success of the scheduled training session.
Learn How To Think Like The FDA ®
GCGI's training sessions are developed and scheduled at your convenience. GCGI fits the training at your needs:
GCGI’s Training Program delivers comprehensive educational skills tailored from one (1) to eighteen (18) contact hours, although additional training time can be customized to client needs. Training activities encompasses:
REGULATORY COMPLIANCE SERVICES