Learn How To Think Like The FDA ®
“Established since 1999”
REGULATORY COMPLIANCE SERVICES
Since 1999, Johnny Guerra has provided valuable FDA-related services to thousands of clients all over the world. Here are some testimonials of what they have to say:
4.“Guerra’s expertise and implementation of a QA Compliance Investigation Unit (CIU) allowed us to resolve numerous quality issues that were impacting the quality of our drug products. His unique teaching style allowed us to understand and properly document all laboratory failure investigations and manufacturing quality events. We were able to combine good regulatory writing techniques, practical understanding of process development to process validation and analytical method validations as well. We learned how to convert technical and regulatory concepts into practical and effective CAPAs. We advise other companies not to wait for a Warning Letter; just hire Johnny Guerra to prevent business interruptions and impact to company’s product branding!”
GCGI’s THREE-TIER PROGRAM
Failure Investigations ™
1. “GCGI’s level of experience, credibility and unique expertise with FDA expectations really helped our manufacturing and laboratory operations put in place a direct compliant structure for good SOPs and recordkeeping, followed by a sustainable system still in place today. Johnny Guerra trained all our personnel, fixed-up all of our GMP systems resulting in zero FDA-483 observations from the Agency during a follow-up inspection”.
2. GCGI was referred to us from a big Pharma company to solve our increasing rate in human error that was impacting the quality of our products.
“Guerra’s understanding of cGMPs and FDA requirements enable us to really comprehend and apply regulatory concepts at both the managerial and operational level. His unique consulting and teaching style provided us with effective and long-lasting solutions ensuring that we succeed at all stages as well. We really learned about “the validated state” and how we can apply such concept during day-to-day activities. Also, we decreased our human error trend by a factor of 40% in just 3 months after implementing his program”.
3. Johnny Guerra was hired by a multi-national pharmaceutical company to provide web-based trainings to worldwide personnel in “Data Integrity for Laboratory Operations”. Training was delivered to +150 employees located in USA, Canada, Europe, Brazil, Mexico, Puerto Rico and Argentina including both English and Spanish language versions.
“Guerra’s in-depth understanding of data integrity requirements provided us with the knowledge and skills to help us solve all aspects of data integrity issues observed during local and corporate laboratory audits. The experience gathered during in-depth training lectures was of extreme benefit on data integrity issues observed with contract laboratories and instrument/equipment vendors extending the concept to manufacturing operations. Thanks again Johnny, for all your efforts and continuous support!”
Web Seminar Testimonials:
1. “GCGI’s THREE-TIER PROGRAM has been responsible for a 70-85% reduction in our Human Errors!”
2. “In our recent FDA audit, the FDA investigator commented on the quality and thoroughness of our manufacturing and laboratory investigations. He added, ...the best investigations I have seen in my 18+ years as an Investigator with the FDA.”
3. “We just recently concluded the FDA Inspection. The FDA Investigator acknowledged the fact that all issues he can think of were properly addressed during the investigation including CAPAs. He even said, ...Congratulations!”
1."Fantastic! I greatly appreciate how you are able to fully explain the rationale behind each response. I find that is the most important and challenging aspect of meeting regulations - anyone can read and understand them, but exactly how to implement them in your systems is a much more complicated issue, even simple things like dating and initialing. Thanks again for your time.”
2. “Mr. Guerra, I just wanted to let you know how much I enjoyed your seminar. I have been to many through the years, but yours was very informative in a short of time.”
3. “Mr. Guerra, thanks very much for your presentation yesterday. Our staff enjoyed hearing your tips and suggestions on meeting FDA and 21 CFR 58 requirements, and I think they will help us to improve compliance within our systems.”
4. “Thank you Johnny. The training definitely provided a lot of food for thought and this was helpful. It’s been an on-going debate as to how long we should keep documents”.
5. “Hi Johnny. It was a very informative webinar and you are quite experienced in your speech topic.”
6. “Hi Johnny. Thank you for putting on an excellent presentation this morning on Human Errors. I was attracted to your seminar because of my project and the difficulty in establishing best practice within the industry. I like your categories better than ours and plan to re-characterize our assessment based on your work. Your points on corporate policy, and “right supervisors” are well taken. Nothing leads to cultural change like the act of measurement. Thanks again for putting on a good show, and for taking the time to reply to my questions.”