FDA-oRIENTED
“Established since 1999”
GUERRA
consultinggroup,inc.™
REGULATORY COMPLIANCE SERVICES
- “It makes a big difference to have someone who worked with the FDA for so many years and is able to transmit that knowledge to us!”
- “Excellent presentation! Every part of the course program was current, relevant and practical. Mr. Guerra delivered a wealth of knowledge to our employees. I am recommending personnel from other areas to attend this course.”
- “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.”
- “The course was very informative, particularly the exercise sessions. I will take more courses like this one.”
MEETING FDA &
cGMP REQUIREMENTS
CATEGORY III:
CATEGORY II:
EQUIPMENT QUALIFICATIONS
- An FDA Regulatory Perspective to Laboratory & Manufacturing Equipment Validations.
- DQ, IQ, OQ, PQ and PV in Laboratory & Manufacturing Operations.
- ISO 17025 Approach to Instrument Qualification and Certification.
- A cGMP and ISO Approach to Calibration.
- Preventing FDA-483s in Laboratory and Manufacturing qualification data.
- Auditing laboratory and
manufacturing equipment companies. - Documenting failures during
equipment calibration and qualification activities.
- Computer and Software System Validation for Manufacturing and Laboratory Systems.
- A GAMP Approach to CSV.
- Development of DQ: Validation Plan,
URS, FRS, Vendor Audit and SDS. - Development of Functional Testing
Requirements. - A cGMP Approach to CSV Vendor
Audit. - Proper Documentation of CSV Quality
Events and CAPAs. - Documenting Field Acceptance
Testing (FAT) to meet FDA and cGMP
requirements.
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.
GCGI's Training Program is divided into six categories including a Human Error Program, Quality Events and Failure Investigations Certification Program and a Computer System Validation (CSV) Certification Program. Customized courses could be developed by combining two or more titles from one or more categories. Training sessions include PDF handouts and Certificate of Participation. Optional course manuals available by request.
The following list shows course titles that will help you obtain the required knowledge, skills and expertise to meet the regulatory compliance demands.
Join the hundreds of satisfied participants who are currently applying the acquired regulatory and FDA compliance Knowledge!
ELECTRONIC RECORDS;
ELECTRONIC SIGNATURES
(21 CFR Part 11)
Increase Your Knowledge and Skills
CATEGORY VI:
ANALYTICAL LABORATORY
HUMAN ERROR,
QUALITY EVENTS & PROCESS/
BUSINESS EXCELLENCE
CATEGORY V:
- “Mr. Guerra is a great instructor with excellent communication skills for the course provided and better when compared to other courses I have attended in the past. He is very knowledgeable and delivered a good balance between regulatory requirements and business needs.”
- “Excellent workshop section! The use of exercise activities enhanced the learning experience and was very effective too. I also enjoyed the group exercises that shared our company’s operation concerns including corrective and preventive actions to solve our regulatory and business issues as well. I got many ideas and helpful information to assist me in my investigations.”
- “Computer and Software Validation, including Part 11, are difficult topics to grasp. This course made the topic crystal-clear.”
Training
Courses
Ready to improve your technical and regulatory skills?
Read From GCGI’s Past Training Attendees...
"I would like to congratulate you on the presentation you gave to us last week on the topic of Analytical Method Validation. It was great to hear about the latest FDA cGMP inspection trend surrounding this topic in a way that everyone present could easily understand. I know that I am much better informed that I was, and I am much more confident about what the future holds in our sister sites. Once again, thank you Mr. Guerra for such a rewarding experience."
CATEGORY I:
- Annual GMP Training for Medical Device and Pharma Industries.
- Vendor Audits and Manufacturing Supplier Certification Program.
- How to be prepared for an FDA Audit: Laboratory & Manufacturing.
- Regulatory Aspects of Quality by Design (QbD) and Process Analytical Technology (PAT).
- Good Documentation Practices for Engineering, Facilities and Utilities.
- How to Prevent and/or Address FDA-483 and/or WL observations.
- FDA Perspective to Batch Record Review.
- An FDA Auditing Approach to Pre-Approval Inspections (7 modules).
- How to Audit for GLP, 21 CFR Part 58 Compliance.
- An FDA and ICH Approach to Analytical Method Validation.
- CGMP Compliance and Auditing in the Quality Control Laboratory.
- CGMP Quality Indicators in FDA Regulated Laboratory Systems.
- USP/NF Methodology: Understanding the Reference.
- CGMP Compliance in HPLC Systems.
- Good Laboratory & Documentation Practices.
- Laboratory Auditing Techniques Workshop.
- Analyst Certification Program.
- Data Integrity in Laboratory Operations.
- A GMP Approach to the Detection, Correction & Prevention of Human Errors.
- ICH Q8, Q9 & Q10 as a Preventive Quality Tool in the Pharma Industry.
- An FDA Regulatory Perspective to Training Effectiveness.
- An FDA Regulatory Approach to Six Sigma for Business Excellence.
- Documentation of Failure Investigations and Quality Events.
- A Regulatory and Business Perspective to CAPA Effectiveness.
- FDA Approach to Process Validation.
- Investigating Out-Of_Specification (OOS) Test Results for Pharmaceutical Production.
COMPUTER SYSTEM VALIDATION
(CSV)
- A Software Approach to Part 11.
- A Management Perspective to ER/ES.
- Part 11 “Scope and Application” - FDA Requirements.
- Vendor Audit Requirements under Part 11.
- CSV Auditing Techniques within Part 11.
- Application of Part 11 in Process Analytical Technology (PAT).
- An FDA Approach to Inspection Readiness for Part 11.
- An FDA Regulatory Perspective to Data Integrity and Part 11.
CATEGORY IV:
Learn How To Think Like The FDA ®