FDA Regulatory Compliance Advisors, Inc.™
Understand FDA's rationale when documenting Failure Investigations and Quality Events.
Learn how to emulate the FDA Investigator’s thinking while documenting a deviation or quality event.
Learn how to document a deviation in terms of impact to product quality.
Learn how to document deviations related to human error.
Learn Root-Cause-Analysis and apply Problem-Solving Techniques to 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).
FDA-RCA’S FAILURE INVESTIGATION AND CAPA SYSTEM™
“Excellent, the best course I have ever taken! Rebeca delivered an engaging and valuable workshop in Failure Investigations and CAPA System. What stands out is that she is flexible, listens well and was able to adapt her expertise to individuals and groups needs during exercise and case study sessions.”
“ As a team leader, Rebeca’s training approach reinforces learning and provided our participants with much to think about, skills to apply when we returned to our own workplace and strategies to use when leading and working with other manufacturing and laboratory areas.”
“Feedback was excellent from all participants. Top qualities of FDA-RCA’s Failure Investigation and CAPA System™ training course: Great Training Manual, Great Training Aids and superb training skills! Thank you Rebeca.”
“ Rebeca’s training was voted one of the most useful and engaging of all times in our company. And still two years after the training, we keep receiving great feedback from her training skills. Rebeca made a concerted and successful effort to ensure her training was tailored to the audience and that effort was very much reflected in participant’s feedback.”
“One of the best web presentations I have participated in — very well presented. Rebeca knew her topic, held your interest and I really enjoyed the style, particularly during workshop and exercise discussions.”
“Rebeca’s training provided me with insight on how to create a learning culture from our human error events. I am in a new role and this will help me lead my team and will coach others managers to do the same. Having now a deep understanding on how to conduct human error investigations, I will be able to manage employee relationships better and help our organization be one of the best to work for.”
1. Root-Cause-Analysis (RCA).
2. Problem-Solving Tools (PST).
CASE STUDY: Documenting a
1. Failure Investigations Flowchart.
2. Failure Investigations Checklist.
3. Microbial Investigations: Microbial
1. Thirty (30) hours of lectures, exercises and workshop sessions.
2. Three (3) hours / web session, three (3) times / week.
3. The training manual contains more than 225 pages.
4. Course Certificate: Proctored and Non-proctored versions.
1. Types of Human Errors.
2. Human Performance Factors.
3. Documenting Human Error Quality Events.
Regulatory compliance web-based trainings (WBT) are developed and presented by Ms. Rebeca Rodríguez, Industry Advisor and Former FDA National Expert Investigator / Former FDA National Lead Instructor.
Web-based sessions integrate case studies with lectures and exercises. Participants are able to work on assigned case studies followed by individual evaluations and group discussions.
FDA-RCA™ has experience offering web sessions through Microsoft Teams® (MT) and WebEx® communication and collaboration platforms.
Training services are quoted and delivered to group bundles of thirty (30) participants. Additional sessions could be scheduled for more than thirty (30) participants.
Learn now from this outstanding presenter offering the most cutting-edge regulatory enhanced comprehension available. Web-based courses are delivered from six (6) to thirty (30) hours in length. Web-based training materials include lectures, training aids, exercises, workshop sessions and course certificate.
See our training course TOPICS
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Failure Investigation Template:
2. Manufacturing Operations.
and related branding marks are the legal property of their respective owners.
Failure Investigation Template:
1. Laboratory Operations.
Training Course Benefits...
Microsoft Teams and Cisco Webex registered trademarks, service marks,
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SIX KEY SUCCESS AREAS:
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FDA REGULATORY COMPLIANCE ADVISORS, INC.
P.O. BOX 31195
SAN JUAN, P.R. 00929-2195
PHONE: (787) 755-7841
MOBILE: (787) 390-6020