Root Cause Analysis and CAPA

  • Speaker:Susanne Manz
  • Date: 10th October 2018 10:00 AM PST | 01:00 PM EST
  • Duration:90Min
  • Product Code:GRC-90395

$189

14

DAYS
Left to Register

Live Session - How it works

  • Username and Password will be sent to you within 24 hours prior to the webinar.
  • Presentation handouts in pdf format will be emailed to along with the login instructions or few hours before the meeting starts.
  • Login to the session by clicking on “Join the Meeting” in the login instructions and then dial the number to connect to the meeting audio or use your Computer to connect to audio. Please use the name and the email address you used at the time of registration to join the meeting.
  • Get answer to your queries through interactive Q&A sessions. The Q and A sessions are at the end of the meeting. The expert will complete his/ her presentation and then the phone lines will be open for the audience to discuss your questions.
  • Please let us know your thoughts and views at the end of webinar, your valuable feedback will help us improve our Training programs.
  • Certificate of attendance is emailed to you within 6 working days from the date the webinar was completed. If you don’t receive an email within 6 days. Please email our support@grcts.com

Recorded Session - How it works

  • Login Information with Password to view the webinar will be emailed to you within 48 hours from the date the Live webinar was completed. The link to the recording is for a single person use only and it is valid for 6 months or the actual duration the recording was purchased.
  • Please click on the link to access the Recording and type in the password provided in the email.
  • Presentation and other handouts will be emailed to you in a pdf format.

Training CD - How it works

  • Free shipment within 2 working days, from the date the webinar was completed. The presentation and other handouts will be emailed to you in a pdf format if we are unable to attach them in the CD or USB.

(For more information about our products contact +1- 248-233-2049)

If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. Access the recording of the webinar for 6 months. Contact our support for any questions. To prepare an invoice to pay by Check or Wire email us at support@grcts.com.

Certification: GRCTS Completion Certificate

Description:

Conducting an effective root cause analysis can be a daunting task. And without a good root cause analysis, your CAPA will not result in the desired improvement. This webinar will give you insights and lessons learned from an industry expert with over 30 years’ experience. You will learn how to get permanent resolution to your serious quality problems.

CAPA is the cornerstone of an effective Quality System for Medical Device companies. However, it is still the number one cause of 483 and Warning Letter Observations. Without an accurate root cause analysis it is impossible to correct and prevent quality and compliance issues. Many companies struggle with inadequate root cause analysis resulting in on-going quality and compliance problems. This webinar will help you improve your root cause analysis leading to real and lasting improvements.

Objectives:

  • FDA Expectations
  • A Methodical Process for Root Cause Analysis
  • Root Cause Analysis Techniques
  • Do's and Don'ts
  • Myths of Root Cause Analysis
  • Documentation Expectations

Topics:

  • Build the right team
  • Develop a problem statement
  • Data collection
  • Analysis tools and techniques
  • How to verify your results
  • RCA tool box
  • Real lessons learned
  • Dos and don’ts of RCA
  • Case studies

Who can Benefit

  • Quality, Manufacturing, Design, or Process Engineers
  • Compliance Specialists, Auditors
  • Compliance Managers
  • CAPA Specialists / Managers
  • Regulatory Affairs Managers

Instructor Profile:

Susanne Manz, MBA, MBB, RAC, CQA is an accomplished leader in the medical device industry with emphasis on quality, compliance, and six sigma.  She has an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities.  While at GE, J&J, and Medtronic, Susanne worked in various world-wide roles including Executive Business Consultant, WW Director of Quality Engineering and, Design Quality, and Director of Corporate Compliance.  

Susanne has a BS in Biomedical Engineering and an MBA from the University of NM.  She earned her Black Belt and Master Black Belt certifications while at Johnson and Johnson.  Susanne also holds Regulatory Affairs Certification (RAC) from RAPS and Certified Quality Auditor (CQA) certification from the American Society for Quality.  Susanne has now established a consulting business with a mission to provide services to help medical device companies achieve world-class quality and compliance.  

Available Options

Live Meeting Access Single: Attend the Live Meeting Online from any location

$189

2 Single Live Access: 2 people can attend the meeting Live from any location

$289

Recording: 6 Months Access to the Training which can be accessed from any location

$259

CD-DVD: Shipped within 2 working days

$359

USB - Shipped within 2 working days

$389

Live + Recording: Attend Live Meeting Online + Access the recording for 6 months

$289

Live + CD: Attend Live Meeting Online + Get the training CD shipped for free

$389

Live + USB - Attend Live online + Get the training USB shipped for free

$409

5 Member Group: 5 people can Attend the Live Online Meeting from any location globally

$539

10 Member Group: 10 people can Attend the Live Online Meeting from any location globally

$839

Related Products

Writing and Enforcing Effective SOPs

Writing and Enforcing Effective SOPs

If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. Access the recording of the webinar for 6 months. Contact our support for any questions. To prepare an invoice to pay by Check or Wire email us at support@grcts.com.Description: Writing SOPs or procedural documents can be challenging at times. However, writing SOPs is overall a straightforward process. However, enforcing what you already created and implemented in the pipeline is another stor..

$269

How to Prepare Yourself for FDA's on-going Part 11 Inspection Program

How to Prepare Yourself for FDA's on-going Part 11 Inspection Program

If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. Access the recording of the webinar for 6 months. Contact our support for any questions. To prepare an invoice to pay by Check or Wire email us at support@grcts.com.Description:FDA continues to enforce Part 11 through its new Part 11 inspection and enforcement program. Just in the last 3 years, FDA issued more than 30 warning letters with Part 11 violations. Citations are related to inadequate integr..

$279

Validation of Analytical Methods according to the New FDA Guidance

Validation of Analytical Methods according to the New FDA Guidance

If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. You can access the recording of the webinar for 6 months. Contact our support for any clarifications. Certifications: GRCTS Attendance CertificateDescription:FDA has released a new comprehensive guidance for validation of analytical methods. The guidance follows the modern integrated life cycle approach with related new requirements for using quality-by-design components, risk assessment, design..

$269

Comparing GLP with GMP

Comparing GLP with GMP

If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. Access the recording of the webinar for 6 months. Contact our support for any questions. To prepare an invoice to pay by Check or Wire email us at support@grcts.com. Description:Good Laboratory and Good Manufacturing practices are regulations that are applied during different lifecycle phases of drugs and drug substances. Both regulations have some common requirements but there are also signific..

$269

Requirements of Validation – IQ, OQ and PQ Protocols

Requirements of Validation – IQ, OQ and PQ Protocols

If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. Access the recording of the webinar for 6 months. Contact our support for any questions. To prepare an invoice to pay by Check or Wire email us at support@grcts.com.Description:Validation is an important element of the Quality System Regulations and ISO13485.   This course will cover the requirements the essentials of validation.  You’ll learn about what processes needed to be validate..

$289

Investigating OOS and OOT Results

Investigating OOS and OOT Results

If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. Access the recording of the webinar for 6 months. Contact our support for any questions. To prepare an invoice to pay by Check or Wire email us at support@grcts.com. Description:This webinar will review the regulatory requirements for investigating an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed. A detailed flow chart will be used to help the at..

$259

Quality System Structure and Development for Medical Device Companies

Quality System Structure and Development for Medical Device Companies

If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. Access the recording of the webinar for 6 months. Contact our support for any questions. To prepare an invoice to pay by Check or Wire email us at support@grcts.com. Description:This webinar will help you to develop a Quality Management System (QMS) for Medical Device Companies.  A well-structured QMS meets the requirements of the Quality System Regulations and is both effective and efficie..

$249

Understanding the new Revision of USP 1058: Analytical Instrument Qualification

Understanding the new Revision of USP 1058: Analytical Instrument Qualification

If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. Access the recording of the webinar for 6 months. Contact our support for any questions. To prepare an invoice to pay by Check or Wire email us at support@grcts.com.Description:  The first version of USP <1058> has been released in 2008. Since then it has evolved to the global standard for analytical instrument qualification. In August 2017 a new revision has been released with many n..

$269

Good Documentation Practice and Record Keeping Regulations (FDA & EMA)

Good Documentation Practice and Record Keeping Regulations (FDA & EMA)

If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. Access the recording of the webinar for 6 months. Contact our support for any questions. To prepare an invoice to pay by Check or Wire email us at support@grcts.com. Certifications: GRCTS Attendance Certificate -Background:Good documentation Practices (GDP) is an essential factor that needs to be closely followed by the personnel in any regulated environment as a process for a successful proje..

$259

Medical Device Design: Dos and Don'ts - Special Considerations

Medical Device Design: Dos and Don'ts - Special Considerations

If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. Access the recording of the webinar for 6 months. Contact our support for any questions. To prepare an invoice to pay by Check or Wire email us at support@grcts.com. Description:Medical device manufacturers are required to establish and maintain FDA-compliant quality management systems, where appropriate and applicable, including a design control subsystem.  This presentation is intend..

$3269

Scrutinizing Test Method Validation (TMV) to Verify the Performance of a Medical Device

Scrutinizing Test Method Validation (TMV) to Verify the Performance of a Medical Device

If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. Access the recording of the webinar for 6 months. Contact our support for any questions. To prepare an invoice to pay by Check or Wire email us at support@grcts.com.Background:Test method validation is an often-confusing requirement for medical devices.  A fundamental issue is the role-reversal between the test method and the product or process it is designed to detect.   For example, ..

$269

What Medical Device Industry Should Do to Adequately Implement a Quality Risk Management System?

What Medical Device Industry Should Do to Adequately Implement a Quality Risk Management System?

If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. Access the recording of the webinar for 6 months. Contact our support for any questions. To prepare an invoice to pay by Check or Wire email us at support@grcts.com. Description:This presentation is intended to help you get familiar with best practices for quality risk management (QRM) applicable for medical device industry.This seminar is further intended to discuss how quality risk management ..

$4749

Classify Medical Devices In Both The EU (Applying The New EU Regulation) And The US

Classify Medical Devices In Both The EU (Applying The New EU Regulation) And The US

If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. Access the recording of the webinar for 6 months. Contact our support for any questions. To prepare an invoice to pay by Check or Wire email us at support@grcts.com.Description:The Food and Drug Administration (FDA) has established classifications for approximately 1,700 different generic types of devices and grouped them into 16 medical specialties referred to as panels. Each of these generic types ..

$269

Regulations for Advertising Cannabis in the USA,

Regulations for Advertising Cannabis in the USA,

If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. Access the recording of the webinar for 6 months. Contact our support for any questions. To prepare an invoice to pay by Check or Wire email us at support@grcts.com.Certification: GRCTS Certification of CompletionDescription: Although Cannabis use is illegal at the federal level and although there are only nine states where sale and possession of cannabis is legal for both medical and recreation..

$249

Medical Device Recalls – A Complete Prevention Strategy

Medical Device Recalls – A Complete Prevention Strategy

If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. Access the recording of the webinar for 6 months. Contact our support for any questions. To prepare an invoice to pay by Check or Wire email us at support@grcts.com. Topic Description:In a recent study, the FDA has reported a 95% increase in medical device recalls over a nine year period ending in 2017 attributable to a variety of reasons.  Whatever the reason, medical device recalls are ex..

$259

Implementing the Best Practices for FDA Inspection Preparation and Management

Implementing the Best Practices for FDA Inspection Preparation and Management

If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. Access the recording of the webinar for 6 months. Contact our support for any questions. To prepare an invoice to pay by Check or Wire email us at support@grcts.com. CertificationsGRCTS Attendance CertificateDescription: This seminar will discuss guidelines to adequately implement the best practices for FDA inspection preparation and management compliant with the Good Manufacturing Practices ..

$259

Moving from the GMPs to the Pharmaceutical Quality System

Moving from the GMPs to the Pharmaceutical Quality System

If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. Access the Recording of the Training for 6 months. Contact our support for any questions. To prepare an invoice to pay by Check or Wire email us at support@grcts.com. Certification: GRCTS Completion Certificate.Topic Background:Since the turn of the century, the FDA has been promoting the idea of a Pharmaceutical Quality System.  This is supported by an FDA Guidance Document: Guidance ..

$2649

Preventing Human Error in the Life Sciences

Preventing Human Error in the Life Sciences

If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. Access the Recording of the Training for 6 months. Contact our support for any questions. To prepare an invoice to pay by Check or Wire email us at support@grcts.com. Certification - GRCTS Attendance CertificateBackground:       This webinar will explore the true causes and nature of human error, how human error should be investigated, how human error relates to human ..

$269

US FDA Pre-Submission process, IDE, 510(k), PMA and IVD

US FDA Pre-Submission process, IDE, 510(k), PMA and IVD

If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. Access the Recording of the Training for 6 months. Contact our support for any questions. To prepare an invoice to pay by Check or Wire email us at support@grcts.com. Certifications: GRCTS Attendance CertificateTopic description:  This webinar will discuss all aspects of the US FDA Pre-Submission process.  This webinar will review when a Pre-submission may be appropriate for a compan..

$259

Mitigate Fiscal Risks in Clinical Trials: Coverage Analysis, Budgeting and Billing Compliance.

Mitigate Fiscal Risks in Clinical Trials: Coverage Analysis, Budgeting and Billing Compliance.

If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. Access the Recording of the Training for 6 months. Contact our support for any questions. To prepare an invoice to pay by Check or Wire email us at support@grcts.com. Certifications: GRCTS Attendance Certificate. Background:      This webinar is an integrative learning experience, combining a comprehensive review of the good clinical practice core principles and projec..

$259

Medical Device Risk Analysis in the Design Process

Medical Device Risk Analysis in the Design Process

If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. Access the Recording of the Training for 6 months. Contact our support for any questions. To prepare an invoice to pay by Check or Wire email us at support@grcts.com. Certification: GRCTS Attendance CertificateBackground:Medical Devices by their very nature must be safe for human use and must meet the requirements for which they have been designed.  The process which identifies the risks ..

$2659