See What Auditors See: Prepare for FDA Audits with Insider Insights
Don’t Get Caught Off-Guard: Master FDA Audit Readiness and Avoid Common Pitfalls!
Instructor :
Jose Mora
Webinar ID:
11822
Date: DEC 13, 2024 (FRI)
Start Time: 10 AM PT - 11:30 AM PT
Duration: 90 Mins.
Buy This Course in a Pack at 35% Discount HERE: FDA Compliance Mastery Pack of 3!!
Courses Included:
-
- Stop Costly 483 Citations in Their Tracks: Master Spreadsheet Validation and Protect Your Compliance (duration 75 mins.), find out more details here
- See What Auditors See: Prepare for FDA Audits with Insider Insights (duration 90 mins.), find out more details here
- CAPA Under the FDA Lens: Why Do CAPA Systems Fail, and How Can You Ensure Yours Doesn’t? (duration 90 mins.), find out more details here
Why Buy This Pack?
-
- These courses collectively address ….
Buy This Course in a Pack at 35% Discount HERE: FDA Compliance Mastery Pack of 3!!
Courses Included:
-
- Stop Costly 483 Citations in Their Tracks: Master Spreadsheet Validation and Protect Your Compliance (duration 75 mins.), find out more details here
- See What Auditors See: Prepare for FDA Audits with Insider Insights (duration 90 mins.), find out more details here
- CAPA Under the FDA Lens: Why Do CAPA Systems Fail, and How Can You Ensure Yours Doesn’t? (duration 90 mins.), find out more details here
Why Buy This Pack?
-
- These courses collectively address core FDA compliance challenges, focusing on both proactive and reactive strategies. Spreadsheet validation, audit readiness, and CAPA systems are interrelated areas crucial for maintaining compliance.
- This pack provides a comprehensive understanding of compliance strategies, helping professionals minimize the risk of citations, enhance data integrity, and improve audit outcomes.
- Holistic Learning Experience: The courses cover critical compliance aspects, offering a complete approach to managing compliance risks.
- Cost Savings: Purchasing the pack provides a cost-effective solution compared to buying individual courses.
- Enhanced Skill Set: Participants will gain a broad set of skills, empowering them to handle different aspects of compliance more effectively.
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
-
- Understand What Auditors Focus On And Why It Matters
- Master First Impressions To Set The Tone For Success
- Learn Key Compliance Indicators In Plant And Warehouse Tours
- Gain Insights Into Cleanroom And Lab Area Expectations
- Ensure Instant Access To Critical Documents And Records
- Evaluate And Strengthen Your ….
-
- Understand What Auditors Focus On And Why It Matters
- Master First Impressions To Set The Tone For Success
- Learn Key Compliance Indicators In Plant And Warehouse Tours
- Gain Insights Into Cleanroom And Lab Area Expectations
- Ensure Instant Access To Critical Documents And Records
- Evaluate And Strengthen Your Quality Management System Consistently
- Apply Key Takeaways To Maintain A Culture Of Compliance
Course Description
As we step into a new year, it’s the perfect time to ensure your organization is ready to meet the challenges of FDA audits head-on.
Internal and external audits are essential for maintaining compliance in medical device and biotechnology manufacturing, and a strong start to 2025 begins with understanding what auditors really want to see.
In this 90-minute webinar, discover the insider insights that auditors rely on to assess compliance and uncover actionable strategies to prepare your team for success.
Key Takeaways:
-
- Understand the auditor’s mental checklist and their focus areas
- Learn the cultural and environmental factors that influence audit outcomes
- Master proven techniques to create a strong, lasting impression during audits
This session is your opportunity to kickstart the new year by strengthening your compliance culture and fostering confidence across your team. Align with audit expectations to mitigate risks and showcase excellence in every inspection.
Why You Can’t Miss This:
-
- Set the tone for a compliant and successful 2025
- Stay ahead by adopting the latest audit-readiness strategies
- Empower your team with tools to proactively address auditor priorities
Join Now and make 2025 the year your organization leads with confidence, compliance, and excellence.
Register Today!
As we step into a new year, it’s the perfect time to ensure your organization is ready to meet the challenges of FDA audits head-on.
Internal and external audits are essential for maintaining compliance in medical device and biotechnology manufacturing, and a strong start to 2025 begins with understanding what auditors really want to see.
In this 90-minute webinar, discover the insider insights that auditors rely on to assess compliance and uncover actionable strategies to prepare your team for success.
Key Takeaways:
-
- Understand the auditor’s mental checklist and their focus areas
- Learn the cultural and environmental factors that influence audit outcomes
- Master proven techniques to create a strong, lasting impression during audits
This session is your opportunity to kickstart the new year by strengthening your compliance culture and fostering confidence across your team. Align with audit expectations to mitigate risks and showcase excellence in every inspection.
Why You Can’t Miss This:
-
- Set the tone for a compliant and successful 2025
- Stay ahead by adopting the latest audit-readiness strategies
- Empower your team with tools to proactively address auditor priorities
Join Now and make 2025 the year your organization leads with confidence, compliance, and excellence.
Register Today!
Why you should attend
“An auditor doesn’t need to dig deep—they arrive with a clear mental checklist.”
Understanding this checklist and what influences their first impressions is key to securing successful audit outcomes.
Whether it’s your plant’s operations, documentation, or culture of compliance, this training will give you the tools to confidently navigate audits and shine under scrutiny.
Here’s Why This Course is Essential for You:
-
- See through an auditor’s eyes: Gain insights into how auditors form their first impressions and why this matters for your plant’s reputation and your career.
- Learn where auditors look first: From your cleanroom gowning area to janitor’s closets, discover the often-overlooked areas that influence audit outcomes.
- Master documentation readiness: Auditors expect instant access to procedures, reports, and manuals—learn how to meet their expectations effortlessly.
- Evaluate your compliance culture: Auditors value consistency. Ensure you’re practicing what you preach and adhering to your own procedures.
- Improve process and environmental controls: Understand the visual cues auditors rely on to assess your control systems and ensure you leave no weak points.
What You’ll Achieve:
-
- Build confidence in presenting a state of control that impresses auditors
- Minimize compliance risks by preparing your team to handle audits smoothly
- Create a culture of continuous readiness that goes beyond the audit itself
This training is your chance to proactively address the challenges of audits and position yourself and your team for success. Prepare now to stay ahead in 2025 and beyond.
Enroll Today and start shaping the way your organization approaches compliance and audit excellence!
“An auditor doesn’t need to dig deep—they arrive with a clear mental checklist.”
Understanding this checklist and what influences their first impressions is key to securing successful audit outcomes.
Whether it’s your plant’s operations, documentation, or culture of compliance, this training will give you the tools to confidently navigate audits and shine under scrutiny.
Here’s Why This Course is Essential for You:
-
- See through an auditor’s eyes: Gain insights into how auditors form their first impressions and why this matters for your plant’s reputation and your career.
- Learn where auditors look first: From your cleanroom gowning area to janitor’s closets, discover the often-overlooked areas that influence audit outcomes.
- Master documentation readiness: Auditors expect instant access to procedures, reports, and manuals—learn how to meet their expectations effortlessly.
- Evaluate your compliance culture: Auditors value consistency. Ensure you’re practicing what you preach and adhering to your own procedures.
- Improve process and environmental controls: Understand the visual cues auditors rely on to assess your control systems and ensure you leave no weak points.
What You’ll Achieve:
-
- Build confidence in presenting a state of control that impresses auditors
- Minimize compliance risks by preparing your team to handle audits smoothly
- Create a culture of continuous readiness that goes beyond the audit itself
This training is your chance to proactively address the challenges of audits and position yourself and your team for success. Prepare now to stay ahead in 2025 and beyond.
Enroll Today and start shaping the way your organization approaches compliance and audit excellence!
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.
