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: JAN 24, 2025 (FRI)
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
As the new year begins, now is the time to ensure your organization is audit-ready and poised for success in navigating FDA compliance requirements.
FDA audits—both internal and external—are pivotal for maintaining compliance in medical device and biotechnology manufacturing.
To start the year strong, it’s crucial to understand exactly what auditors look for and how to exceed their expectations.
In this 90-minute webinar, you’ll gain exclusive insider insights into the audit process and learn actionable strategies to help your team excel during inspections.
What You’ll Learn:
-
- Uncover the auditor’s mental checklist and focus areas critical to compliance.
- Understand the cultural and environmental factors that shape audit outcomes.
- Master proven techniques to create a strong, lasting impression during audits.
Key Benefits:
-
- Set the tone for a compliant and successful 2025.
- Stay ahead of the curve with latest audit-readiness strategies.
- Equip your team with tools to confidently address auditor priorities.
This session is your opportunity to enhance your organization’s compliance culture, mitigate risks, and showcase excellence during every inspection.
Be proactive, not reactive—position your organization as a leader in FDA compliance.
Don’t miss out—make 2025 the year your organization leads with confidence, compliance, and success!
Register Today to secure your spot and take the first step toward audit excellence.
As the new year begins, now is the time to ensure your organization is audit-ready and poised for success in navigating FDA compliance requirements.
FDA audits—both internal and external—are pivotal for maintaining compliance in medical device and biotechnology manufacturing.
To start the year strong, it’s crucial to understand exactly what auditors look for and how to exceed their expectations.
In this 90-minute webinar, you’ll gain exclusive insider insights into the audit process and learn actionable strategies to help your team excel during inspections.
What You’ll Learn:
-
- Uncover the auditor’s mental checklist and focus areas critical to compliance.
- Understand the cultural and environmental factors that shape audit outcomes.
- Master proven techniques to create a strong, lasting impression during audits.
Key Benefits:
-
- Set the tone for a compliant and successful 2025.
- Stay ahead of the curve with latest audit-readiness strategies.
- Equip your team with tools to confidently address auditor priorities.
This session is your opportunity to enhance your organization’s compliance culture, mitigate risks, and showcase excellence during every inspection.
Be proactive, not reactive—position your organization as a leader in FDA compliance.
Don’t miss out—make 2025 the year your organization leads with confidence, compliance, and success!
Register Today to secure your spot and take the first step toward audit excellence.
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.
- Uncover where auditors look first: From cleanroom gowning areas to janitor’s closets, explore often-overlooked areas that can shape audit outcomes.
- Master documentation readiness: Understand how to provide instant access to procedures, reports, and manuals to meet auditor expectations with ease.
- Evaluate your compliance culture: Ensure you’re consistently practicing what you preach by adhering to your own procedures and policies.
- Strengthen process and environmental controls: Identify the visual cues auditors rely on to assess your systems and eliminate weak points.
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.
- Uncover where auditors look first: From cleanroom gowning areas to janitor’s closets, explore often-overlooked areas that can shape audit outcomes.
- Master documentation readiness: Understand how to provide instant access to procedures, reports, and manuals to meet auditor expectations with ease.
- Evaluate your compliance culture: Ensure you’re consistently practicing what you preach by adhering to your own procedures and policies.
- Strengthen process and environmental controls: Identify the visual cues auditors rely on to assess your systems and eliminate weak points.
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
-
- What The Auditor Is Looking For And Why: Learn to decode the auditor’s mindset and their key focus areas to better anticipate their expectations.
- The First Five Minutes: Making A Strong Impression: Understand how to set the tone for a successful audit from the moment an auditor arrives.
- Touring The Plant And Manufacturing Area: Discover the critical visual cues and operational details that auditors assess during their walkthroughs.
- Entering And Touring The Warehouse: Explore how storage practices and organization impact an auditor’s perception of compliance.
- Entering And Touring A Cleanroom: Understand why the cleanroom’s management and controls are pivotal to an auditor’s evaluation.
- Entering And Touring Lab Areas: Gain insights into what auditors look for in lab environments, from safety protocols to operational efficiency.
- Reviewing Documents And Records: Master strategies to ensure immediate access to critical documents, procedures, and reports.
- Assessing The Quality System: Learn how auditors evaluate the effectiveness and consistency of your organization’s quality management system.
- Summary And Key Takeaways: Wrap up with a clear understanding of audit best practices and actionable steps to maintain audit readiness.
BONUS:
-
- Interactive Workshop.
- 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.
-
- What The Auditor Is Looking For And Why: Learn to decode the auditor’s mindset and their key focus areas to better anticipate their expectations.
- The First Five Minutes: Making A Strong Impression: Understand how to set the tone for a successful audit from the moment an auditor arrives.
- Touring The Plant And Manufacturing Area: Discover the critical visual cues and operational details that auditors assess during their walkthroughs.
- Entering And Touring The Warehouse: Explore how storage practices and organization impact an auditor’s perception of compliance.
- Entering And Touring A Cleanroom: Understand why the cleanroom’s management and controls are pivotal to an auditor’s evaluation.
- Entering And Touring Lab Areas: Gain insights into what auditors look for in lab environments, from safety protocols to operational efficiency.
- Reviewing Documents And Records: Master strategies to ensure immediate access to critical documents, procedures, and reports.
- Assessing The Quality System: Learn how auditors evaluate the effectiveness and consistency of your organization’s quality management system.
- Summary And Key Takeaways: Wrap up with a clear understanding of audit best practices and actionable steps to maintain audit readiness.
BONUS:
-
- Interactive Workshop.
- 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.
