FDA INSPECTIONS UNMASKED: SOPs, 483s, and Surviving the Compliance Challenge
Prepare, Navigate, and Respond to FDA Inspections—Gain Peace of Mind Today!
Instructor :
Jose Mora
Webinar ID:
12433
Date: NOV 28, 2024 (THU)
Start Time: 10 AM PT - 11:30 AM PT
Duration: 90 Mins.
Buy This Course in a Pack of 2 courses at 25% Discount HERE:
🏷️ The Data Integrity & Audit Readiness Bundle: Stay Compliant and Audit-Ready
“Master the Essentials of Data Integrity and Prepare for Successful FDA Inspections!”
2 Courses Included:
Why Pack Them Together? Data integrity and successful FDA inspections are intertwined; maintaining compliance with data regulations is a crucial part of being audit-ready. These courses offer a powerful combination to help professionals ensure their data practices are solid and inspections are smooth.
Why Buy the Pack?
-
- Integrated Approach to Compliance: Master the essentials of data compliance and learn how to handle FDA inspections seamlessly.
Buy This Course in a Pack of 2 courses at 25% Discount HERE:
🏷️ The Data Integrity & Audit Readiness Bundle: Stay Compliant and Audit-Ready
“Master the Essentials of Data Integrity and Prepare for Successful FDA Inspections!”
2 Courses Included:
Why Pack Them Together? Data integrity and successful FDA inspections are intertwined; maintaining compliance with data regulations is a crucial part of being audit-ready. These courses offer a powerful combination to help professionals ensure their data practices are solid and inspections are smooth.
Why Buy the Pack?
-
- Integrated Approach to Compliance: Master the essentials of data compliance and learn how to handle FDA inspections seamlessly.
- Stay Audit-Ready: Gain insights that prepare your organization for inspections by ensuring your data systems and processes meet regulatory standards.
- Cost-Efficient Learning: Purchasing these as a pack offers savings and a better return on investment for training budgets.
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 Both Courses at a 25% discount HERE
What will you learn
-
- Understand Types Of FDA Inspections And Their Key Differences
- Prepare Your Organization With Proven Inspection Readiness Strategies
- Identify Key Personnel And Their Roles During Inspections
- Ensure Facility Resources Are Ready To Support Inspection Needs
- Conduct Internal Audits To Identify And Address Compliance Gaps
- Develop SOPs For Consistent And ….
-
- Understand Types Of FDA Inspections And Their Key Differences
- Prepare Your Organization With Proven Inspection Readiness Strategies
- Identify Key Personnel And Their Roles During Inspections
- Ensure Facility Resources Are Ready To Support Inspection Needs
- Conduct Internal Audits To Identify And Address Compliance Gaps
- Develop SOPs For Consistent And Compliant Inspection Management
- Craft Effective Written Responses To FDA 483 Observations
Course Description
Prepare to navigate the complexities of FDA inspections with confidence in this focused 90-minute training session.
This course offers practical insights and actionable strategies for every phase of the inspection process, ensuring you are fully equipped to handle each step seamlessly.
In this session, you will learn how to:
-
- Prepare effectively for an FDA inspection, ensuring that your Standard Operating Procedures (SOPs) align with regulatory requirements.
- Manage the inspection process with ease, from the initial inspection to the close-out interview, minimizing disruptions and maintaining compliance.
- Craft a strong response to 483 observations, ensuring that your responses are thorough, timely, and meet FDA expectations.
Key insights include:
-
- Understanding the limits of the FDA’s authority during inspections—know which documents you can withhold and how to protect sensitive information.
- Guidelines on the permissibility of photographs and affidavits, so you can respond confidently to inspection requests.
This course is ideal for compliance officers, quality assurance professionals, and regulatory affairs managers who want to stay audit-ready and avoid costly mistakes.
Join us to transform your approach to FDA inspections and turn a potential challenge into an opportunity for success!
Enroll Now!
Prepare to navigate the complexities of FDA inspections with confidence in this focused 90-minute training session.
This course offers practical insights and actionable strategies for every phase of the inspection process, ensuring you are fully equipped to handle each step seamlessly.
In this session, you will learn how to:
-
- Prepare effectively for an FDA inspection, ensuring that your Standard Operating Procedures (SOPs) align with regulatory requirements.
- Manage the inspection process with ease, from the initial inspection to the close-out interview, minimizing disruptions and maintaining compliance.
- Craft a strong response to 483 observations, ensuring that your responses are thorough, timely, and meet FDA expectations.
Key insights include:
-
- Understanding the limits of the FDA’s authority during inspections—know which documents you can withhold and how to protect sensitive information.
- Guidelines on the permissibility of photographs and affidavits, so you can respond confidently to inspection requests.
This course is ideal for compliance officers, quality assurance professionals, and regulatory affairs managers who want to stay audit-ready and avoid costly mistakes.
Join us to transform your approach to FDA inspections and turn a potential challenge into an opportunity for success!
Enroll Now!
Why you should attend
Navigating an FDA inspection can be one of the most stressful challenges a regulatory professional faces.
When the FDA arrives, your compliance expertise is in the spotlight, and the stakes couldn’t be higher—a single misstep could have serious implications for your company.
This course is designed to provide you with the knowledge, confidence, and skills to turn this daunting task into a manageable process.
By attending, you will:
-
- Master the art of preparation: Learn how to develop robust Standard Operating Procedures (SOPs) that align with FDA requirements, so you’re ready when the inspectors arrive.
- Stay calm and composed during inspections: Understand what to expect, how to handle challenging questions, and maintain control of the inspection process from start to finish.
- Ensure a positive inspection outcome: Discover how to respond to FDA 483 observations with clear, well-documented responses, helping you minimize risks and avoid costly consequences.
- Protect your company’s reputation: Learn the limits of the FDA’s scope, including which documents are protected, so you can confidently safeguard your organization’s interests.
- Boost your career: Gain insights that position you as a trusted compliance leader who can guide your organization through the most rigorous regulatory challenges.
Don’t leave your company’s future to chance—join us and ensure your next FDA inspection is a success. This training is your opportunity to transform anxiety into mastery and take control of the inspection process like never before.
Register Today!
Navigating an FDA inspection can be one of the most stressful challenges a regulatory professional faces.
When the FDA arrives, your compliance expertise is in the spotlight, and the stakes couldn’t be higher—a single misstep could have serious implications for your company.
This course is designed to provide you with the knowledge, confidence, and skills to turn this daunting task into a manageable process.
By attending, you will:
-
- Master the art of preparation: Learn how to develop robust Standard Operating Procedures (SOPs) that align with FDA requirements, so you’re ready when the inspectors arrive.
- Stay calm and composed during inspections: Understand what to expect, how to handle challenging questions, and maintain control of the inspection process from start to finish.
- Ensure a positive inspection outcome: Discover how to respond to FDA 483 observations with clear, well-documented responses, helping you minimize risks and avoid costly consequences.
- Protect your company’s reputation: Learn the limits of the FDA’s scope, including which documents are protected, so you can confidently safeguard your organization’s interests.
- Boost your career: Gain insights that position you as a trusted compliance leader who can guide your organization through the most rigorous regulatory challenges.
Don’t leave your company’s future to chance—join us and ensure your next FDA inspection is a success. This training is your opportunity to transform anxiety into mastery and take control of the inspection process like never before.
Register Today!
Areas Covered
-
- Types Of Inspections: Understand the different types of FDA inspections and their implications, including routine, for-cause, and follow-up inspections.
- Preparation For Inspections: Learn step-by-step strategies to ensure that your organization is ready for an FDA inspection, from document organization to facility readiness.
- Designating Dedicated Personnel: Identify the key personnel who should be involved during an inspection, and understand their roles and responsibilities for smooth coordination.
- Facility Resources To Support The Inspection: Ensure your facility has the right resources in place to accommodate FDA inspectors, including workspace, documentation access, and technical support.
- Conducting Internal Audits: Master the process of internal audits to identify potential compliance gaps before the FDA arrives, minimizing risks during the inspection.
- Developing SOPs For Inspections: Learn how to create Standard Operating Procedures (SOPs) specifically designed for handling FDA inspections, ensuring consistency and compliance.
- Behavior During The Inspection: Discover best practices for interacting with FDA inspectors, including what to say and do, and what to avoid, to maintain a professional and compliant atmosphere.
- The Inspection Process: Gain a clear understanding of each phase of the inspection, from the initial entrance meeting to document review and the close-out interview.
- Crafting A Written Response: Learn how and when to draft an effective written response to FDA 483 observations, ensuring that your responses are clear, compliant, and timely.
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.
-
- Types Of Inspections: Understand the different types of FDA inspections and their implications, including routine, for-cause, and follow-up inspections.
- Preparation For Inspections: Learn step-by-step strategies to ensure that your organization is ready for an FDA inspection, from document organization to facility readiness.
- Designating Dedicated Personnel: Identify the key personnel who should be involved during an inspection, and understand their roles and responsibilities for smooth coordination.
- Facility Resources To Support The Inspection: Ensure your facility has the right resources in place to accommodate FDA inspectors, including workspace, documentation access, and technical support.
- Conducting Internal Audits: Master the process of internal audits to identify potential compliance gaps before the FDA arrives, minimizing risks during the inspection.
- Developing SOPs For Inspections: Learn how to create Standard Operating Procedures (SOPs) specifically designed for handling FDA inspections, ensuring consistency and compliance.
- Behavior During The Inspection: Discover best practices for interacting with FDA inspectors, including what to say and do, and what to avoid, to maintain a professional and compliant atmosphere.
- The Inspection Process: Gain a clear understanding of each phase of the inspection, from the initial entrance meeting to document review and the close-out interview.
- Crafting A Written Response: Learn how and when to draft an effective written response to FDA 483 observations, ensuring that your responses are clear, compliant, and timely.
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 Assurance Managers Seeking to Minimize Risks During FDA Inspections: Gain the skills to ensure your team’s compliance and preparedness, reducing costly errors.
- Regulatory Affairs Specialists Who Need to Respond Effectively to 483 Observations: Learn how to draft detailed, timely responses that satisfy FDA requirements.
- Compliance Officers Focused on Preparing Their Organizations for Regulatory Scrutiny: Get actionable strategies to ensure smooth and successful FDA inspections.
- Production Managers Looking to Streamline Facility Readiness for Inspections: Understand how to align facility resources to support inspection needs seamlessly.
- Quality Control Supervisors Aiming to Conduct Effective Internal Audits: Identify and address potential compliance gaps before the FDA arrives.
- SOP Writers and Document Control Specialists Crafting Standardized Procedures for Inspections: Develop SOPs that are clear, consistent, and inspection-ready.
- R&D Managers Concerned About Protecting Sensitive Data During Inspections: Learn what information you can withhold and how to safeguard proprietary data.
- HR and Training Managers Developing Compliance Training Programs for Their Teams: Equip staff with the knowledge needed for successful FDA interactions.
- Site Heads Looking to Build a Culture of Inspection Readiness: Create a proactive approach that ensures your team is always audit-ready.
Everybody Benefits from Watching This. Even Better When Done as a Group!
-
- Quality Assurance Managers Seeking to Minimize Risks During FDA Inspections: Gain the skills to ensure your team’s compliance and preparedness, reducing costly errors.
- Regulatory Affairs Specialists Who Need to Respond Effectively to 483 Observations: Learn how to draft detailed, timely responses that satisfy FDA requirements.
- Compliance Officers Focused on Preparing Their Organizations for Regulatory Scrutiny: Get actionable strategies to ensure smooth and successful FDA inspections.
- Production Managers Looking to Streamline Facility Readiness for Inspections: Understand how to align facility resources to support inspection needs seamlessly.
- Quality Control Supervisors Aiming to Conduct Effective Internal Audits: Identify and address potential compliance gaps before the FDA arrives.
- SOP Writers and Document Control Specialists Crafting Standardized Procedures for Inspections: Develop SOPs that are clear, consistent, and inspection-ready.
- R&D Managers Concerned About Protecting Sensitive Data During Inspections: Learn what information you can withhold and how to safeguard proprietary data.
- HR and Training Managers Developing Compliance Training Programs for Their Teams: Equip staff with the knowledge needed for successful FDA interactions.
- Site Heads Looking to Build a Culture of Inspection Readiness: Create a proactive approach that ensures your team is always audit-ready.
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.
