Inside the Auditor’s Mind: Master FDA Audit Preparation with Expert Insights
Master Audit Readiness With Insider Tactics to Ensure Compliance and Confidence!
Instructor :
Jose Mora
Webinar ID:
11822
Date: MAY 07, 2025 (WED)
Start Time: 10 AM PT - 11:30 AM PT
Duration: 90 Mins.
Buy This Course in a Pack of 3 courses at 35% Discount HERE:
🛡️ The Compliance and Approval Accelerator Bundle (Pack of 3 Courses)
“Navigate FDA Approvals with Confidence and Speed!”
3 Courses Included:
-
- Accelerate Your FDA 510(k) and PMA Submissions: A 3-Hour Virtual Seminar for Faster Approval, duration is 3 Hrs., find out more details here
- Fast-Track FDA Approvals: Mastering NDAs, INDs, and Drug Manufacturing Standards for 2025 Success, duration is 60 Mins., find out more details here
- Inside the Auditor’s Mind: Master FDA Audit Preparation with Expert Insights, duration is 90 Mins., find out more details here
Why Pack These Together?
These courses cover every stage of regulatory approval: submissions, drug manufacturing standards, and audit preparation. They’re ideal for professionals responsible for ensuring fast, efficient, and compliant regulatory pathways.
Why Buy the Pack?
-
- Comprehensive Approach: Master the regulatory process from submission to audits.
Buy This Course in a Pack of 3 courses at 35% Discount HERE:
🛡️ The Compliance and Approval Accelerator Bundle (Pack of 3 Courses)
“Navigate FDA Approvals with Confidence and Speed!”
3 Courses Included:
-
- Accelerate Your FDA 510(k) and PMA Submissions: A 3-Hour Virtual Seminar for Faster Approval, duration is 3 Hrs., find out more details here
- Fast-Track FDA Approvals: Mastering NDAs, INDs, and Drug Manufacturing Standards for 2025 Success, duration is 60 Mins., find out more details here
- Inside the Auditor’s Mind: Master FDA Audit Preparation with Expert Insights, duration is 90 Mins., find out more details here
Why Pack These Together?
These courses cover every stage of regulatory approval: submissions, drug manufacturing standards, and audit preparation. They’re ideal for professionals responsible for ensuring fast, efficient, and compliant regulatory pathways.
Why Buy the Pack?
-
- Comprehensive Approach: Master the regulatory process from submission to audits.
- Massive Savings: More affordable than purchasing each webinar separately.
- Target Professionals: Regulatory Affairs Managers, Quality Assurance (QA) Officers, and Compliance Specialists.
Note: Do you want to custom design your pack and choose courses of your choice? Just drop us an email at support@compliancemeet.com or call at Toll Free: +1 (888) 959-4972. We’ll be happy to help you!
Buy All 3 Courses at a 35% discount HERE
What will you learn
-
- Decode Auditor Mindset And Key Focus Areas For Success.
- Make A Strong Impression In The First Five Minutes.
- Understand Critical Visual Cues In Plant And Manufacturing Areas.
- Optimize Cleanroom, Warehouse, And Lab Management For Audit Excellence.
- Ensure Instant Access To Documents, Procedures, And Compliance Records.
- Evaluate And Strengthen Your Quality Management System For ….
-
- Decode Auditor Mindset And Key Focus Areas For Success.
- Make A Strong Impression In The First Five Minutes.
- Understand Critical Visual Cues In Plant And Manufacturing Areas.
- Optimize Cleanroom, Warehouse, And Lab Management For Audit Excellence.
- Ensure Instant Access To Documents, Procedures, And Compliance Records.
- Evaluate And Strengthen Your Quality Management System For Consistency.
- Learn Actionable Audit Best Practices To Maintain Continuous Readiness.
Course Description
In today’s highly regulated Life Sciences landscape, FDA audits remain a critical benchmark for ensuring compliance and safeguarding your organization’s reputation.
Whether you’re in medical device manufacturing, biotechnology, or related sectors, understanding how auditors think—and what they prioritize—can make all the difference between a smooth inspection and costly compliance issues.
This 90-minute expert-led webinar offers exclusive insights into the FDA audit process, designed to help your team navigate inspections with confidence and precision. Go beyond the basics and discover what truly matters during an audit.
Key Learning Objectives:
-
- Decode the FDA auditor’s mindset and uncover their core focus areas.
- Gain clarity on the cultural and environmental factors that influence audit outcomes.
- Master proven strategies to leave a positive, lasting impression during inspections.
- Learn how to foster a compliance-focused culture within your organization.
By the end of this session, you’ll be equipped with practical tools and expert insights to enhance your audit readiness and position your organization for success in 2025 and beyond.
Stay ahead of regulatory expectations—fortify your compliance strategy and confidently face any FDA audit challenge.
Enroll Now!
In today’s highly regulated Life Sciences landscape, FDA audits remain a critical benchmark for ensuring compliance and safeguarding your organization’s reputation.
Whether you’re in medical device manufacturing, biotechnology, or related sectors, understanding how auditors think—and what they prioritize—can make all the difference between a smooth inspection and costly compliance issues.
This 90-minute expert-led webinar offers exclusive insights into the FDA audit process, designed to help your team navigate inspections with confidence and precision. Go beyond the basics and discover what truly matters during an audit.
Key Learning Objectives:
-
- Decode the FDA auditor’s mindset and uncover their core focus areas.
- Gain clarity on the cultural and environmental factors that influence audit outcomes.
- Master proven strategies to leave a positive, lasting impression during inspections.
- Learn how to foster a compliance-focused culture within your organization.
By the end of this session, you’ll be equipped with practical tools and expert insights to enhance your audit readiness and position your organization for success in 2025 and beyond.
Stay ahead of regulatory expectations—fortify your compliance strategy and confidently face any FDA audit challenge.
Enroll Now!
Why you should attend
“An auditor doesn’t need to dig deep—they arrive with a clear mental checklist.”
Understanding this checklist, along with the factors that shape their first impressions, is essential to achieving successful audit outcomes.
Whether it’s your plant’s operations, documentation, or culture of compliance, this training equips you with the tools and strategies to confidently navigate audits and excel under scrutiny.
Here’s Why This Course Is a Must-Attend:
-
- See through an auditor’s eyes:
-
- Learn how auditors form their first impressions and why this impacts your organization’s reputation and your career.
-
- See through an auditor’s eyes:
-
- Uncover where auditors look first:
-
- From cleanroom gowning areas to janitor’s closets, explore often-overlooked areas that can shape audit outcomes.
-
- Uncover where auditors look first:
-
- Master documentation readiness:
-
- Understand how to provide instant access to procedures, reports, and manuals to meet auditor expectations with ease.
-
- Master documentation readiness:
-
- Evaluate your compliance culture:
-
- Ensure you’re consistently practicing what you preach by adhering to your own procedures and policies.
-
- Evaluate your compliance culture:
-
- Strengthen process and environmental controls:
-
- Identify the visual cues auditors rely on to assess your systems and eliminate weak points.
-
- Strengthen process and environmental controls:
What You’ll Achieve:
-
- Confidence in presenting a state of control that impresses auditors.
- Reduced compliance risks by equipping your team to handle audits with ease.
- A culture of continuous readiness that extends beyond a single audit, ensuring long-term success.
This is your chance to proactively tackle audit challenges, strengthen compliance, and position yourself and your organization as leaders in FDA audit readiness. Make 2025 the year you lead with confidence, compliance, and excellence.
Enroll Today and transform how your organization approaches audits and compliance!
“An auditor doesn’t need to dig deep—they arrive with a clear mental checklist.”
Understanding this checklist, along with the factors that shape their first impressions, is essential to achieving successful audit outcomes.
Whether it’s your plant’s operations, documentation, or culture of compliance, this training equips you with the tools and strategies to confidently navigate audits and excel under scrutiny.
Here’s Why This Course Is a Must-Attend:
-
- See through an auditor’s eyes:
-
- Learn how auditors form their first impressions and why this impacts your organization’s reputation and your career.
-
- See through an auditor’s eyes:
-
- Uncover where auditors look first:
-
- From cleanroom gowning areas to janitor’s closets, explore often-overlooked areas that can shape audit outcomes.
-
- Uncover where auditors look first:
-
- Master documentation readiness:
-
- Understand how to provide instant access to procedures, reports, and manuals to meet auditor expectations with ease.
-
- Master documentation readiness:
-
- Evaluate your compliance culture:
-
- Ensure you’re consistently practicing what you preach by adhering to your own procedures and policies.
-
- Evaluate your compliance culture:
-
- Strengthen process and environmental controls:
-
- Identify the visual cues auditors rely on to assess your systems and eliminate weak points.
-
- Strengthen process and environmental controls:
What You’ll Achieve:
-
- Confidence in presenting a state of control that impresses auditors.
- Reduced compliance risks by equipping your team to handle audits with ease.
- A culture of continuous readiness that extends beyond a single audit, ensuring long-term success.
This is your chance to proactively tackle audit challenges, strengthen compliance, and position yourself and your organization as leaders in FDA audit readiness. Make 2025 the year you lead with confidence, compliance, and excellence.
Enroll Today and transform how your organization approaches audits and compliance!
Areas Covered
1. Decoding the Auditor’s Mindset: What They’re Really Looking For
-
- Understand the mental checklist auditors bring to every inspection.
- Identify key focus areas that can make or break compliance outcomes.
2. The First Five Minutes: Setting the Tone for Success
-
- Learn how initial impressions influence the entire audit.
- Discover best practices for welcoming auditors and establishing confidence early.
3. Facility Walkthrough: What Auditors Notice First
-
- Plant and Manufacturing Areas:
-
- Explore the critical visual cues auditors assess in production environments.
-
- Plant and Manufacturing Areas:
-
- Warehouse Operations:
-
- Understand how storage practices, organization, and cleanliness impact compliance perception.
-
- Warehouse Operations:
-
- Cleanroom Management:
-
- Gain insights into the control measures that auditors scrutinize in cleanroom environments.
-
- Cleanroom Management:
-
- Laboratory Areas:
-
- Identify key safety protocols and operational standards auditors expect in lab settings.
-
- Laboratory Areas:
4. Documentation and Records Review: Be Audit-Ready Anytime
-
- Master techniques for quick access to essential documents—procedures, reports, manuals.
- Learn how to present documentation in a way that demonstrates control and consistency.
5. Assessing the Quality Management System (QMS): Prove It Works
-
- Understand how auditors evaluate the effectiveness and compliance of your QMS.
- Discover how to align policies, processes, and culture to reflect audit-readiness.
6. Summary and Key Takeaways: Sustaining a State of Readiness
-
- Consolidate audit best practices and define actionable next steps to maintain ongoing compliance.
- Prepare to foster a culture of continuous improvement within your organization.
BONUS:
-
- PDF copy of the presentation handout for your future reference.
- Soft copy of the certificate of completion on request.
- Q&A Session with the Presenter: Get your pressing questions answered verbally, via chat or email.
1. Decoding the Auditor’s Mindset: What They’re Really Looking For
-
- Understand the mental checklist auditors bring to every inspection.
- Identify key focus areas that can make or break compliance outcomes.
2. The First Five Minutes: Setting the Tone for Success
-
- Learn how initial impressions influence the entire audit.
- Discover best practices for welcoming auditors and establishing confidence early.
3. Facility Walkthrough: What Auditors Notice First
-
- Plant and Manufacturing Areas:
-
- Explore the critical visual cues auditors assess in production environments.
-
- Plant and Manufacturing Areas:
-
- Warehouse Operations:
-
- Understand how storage practices, organization, and cleanliness impact compliance perception.
-
- Warehouse Operations:
-
- Cleanroom Management:
-
- Gain insights into the control measures that auditors scrutinize in cleanroom environments.
-
- Cleanroom Management:
-
- Laboratory Areas:
-
- Identify key safety protocols and operational standards auditors expect in lab settings.
-
- Laboratory Areas:
4. Documentation and Records Review: Be Audit-Ready Anytime
-
- Master techniques for quick access to essential documents—procedures, reports, manuals.
- Learn how to present documentation in a way that demonstrates control and consistency.
5. Assessing the Quality Management System (QMS): Prove It Works
-
- Understand how auditors evaluate the effectiveness and compliance of your QMS.
- Discover how to align policies, processes, and culture to reflect audit-readiness.
6. Summary and Key Takeaways: Sustaining a State of Readiness
-
- Consolidate audit best practices and define actionable next steps to maintain ongoing compliance.
- Prepare to foster a culture of continuous improvement within your organization.
BONUS:
-
- PDF copy of the presentation handout for your future reference.
- Soft copy of the certificate of completion on request.
- Q&A Session with the Presenter: Get your pressing questions answered verbally, via chat or email.
Who is this course for
Everybody benefits from watching this. Even better when done as a group!
-
- Quality Managers Strengthening Audit-Readiness and Ensuring Compliance
- Team Leaders Aligning Operations with Regulatory Standards
- Compliance Officers Staying Ahead of Auditor Expectations
- Training Coordinators Designing Learning Paths for Compliance Success
- HR Professionals Enhancing Workforce Regulatory Knowledge and Practices
- Manufacturing Heads Improving Plant and Cleanroom Protocols
- Document Control Specialists Ensuring Seamless Access to Critical Records
- Lab Managers Meeting Auditor Expectations in Testing Environments
- Executive Leaders Building a Culture of Continuous Compliance
Everybody benefits from watching this. Even better when done as a group!
-
- Quality Managers Strengthening Audit-Readiness and Ensuring Compliance
- Team Leaders Aligning Operations with Regulatory Standards
- Compliance Officers Staying Ahead of Auditor Expectations
- Training Coordinators Designing Learning Paths for Compliance Success
- HR Professionals Enhancing Workforce Regulatory Knowledge and Practices
- Manufacturing Heads Improving Plant and Cleanroom Protocols
- Document Control Specialists Ensuring Seamless Access to Critical Records
- Lab Managers Meeting Auditor Expectations in Testing Environments
- Executive Leaders Building a Culture of Continuous Compliance
Instructor Profile
José Mora is a Principal Consultant specializing in Manufacturing Engineering and Quality Systems. For over 30 years he has worked in the medical device and life sciences industry specializing in manufacturing, process development, tooling, and quality systems.
Prior to working full time as a consulting partner for Atzari Consulting, José served as Director of Manufacturing Engineering at Boston Scientific and as Quality Systems Manager at Stryker Orthopedics, where he introduced process performance, problem solving, and quality system methodologies. During that time he prepared a white paper on the application of lean manufacturing methods to the creation and management of controlled documents and a template for strategic deployment.
José led the launch of manufacturing at a start-up urology products company as Director of Manufacturing for UroSurge, Inc. at the University of Iowa’s business incubator park in Coralville, IA, creating a world-class medical device manufacturing operation, with JIT, Kanban systems, visual workplace and lean manufacturing practices.
José worked for 10 years at Cordis Corporation, now a Cardinal Health company, where he led the successful tooling, process development and qualification of Cordis’ first PTA (percutaneous transluminal angioplasty) catheter. His medical device experience includes surgical instruments, PTA & PTCA dilatation and guiding catheters, plastic surgery implants and tissue expanders, urology implants and devices for the treatment of incontinence, delivery systems for brachytherapy, orthopedic implants and instruments, and vascular surgery grafts and textiles.
During his time at Cordis, José managed the Maintenance and Facilities Department, taking that operation to a level rated as “tops” by the UK Department of Health and Social Services (DHSS) during one of their intensive audits. Jose managed Manufacturing Engineering as part of the Guiding Catheter Core Team of managers, a team that took the Cordis Guiding Catheter business to lead the market, bringing it up from fourth place. By introducing world-class techniques, the Guiding Catheter design and manufacturing was completely re-engineered for robust design and tooling, under Jose’s leadership.
He was also instrumental and played a leadership role in the complete re-engineering of the Tooling Control System, including design drafting, the tool shop and technical support. Wherever he has worked, he has a track record of introducing world-class methodologies such as Kepner-Tregoe, Taguchi techniques, Theory of Constraints, Lean Manufacturing, Five S (Visual Workplace), process validation to Global Harmonization Task Force standards, and similar approaches.
