Requirements of Validation – IQ, OQ and PQ Protocols

  • Speaker:Susanne Manz
  • Duration:90Min
  • Product Code:GRC-90421

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.

Certifications: GRCTS Attendance Certificate

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 validated and what steps you need to take to validate processes.  You’ll learn the essentials of validation planning, protocol writing, and change management.  We’ll cover the steps of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) including tips and best practices.

Why Should You Attend:

Failure to validate is a significant cause of 483 observations.  Even worse, it can result in customer complaints, adverse events, and even recalls. In this webinar, you’ll learn how to avoid these problems and use validation concepts to ensure process stability and control. You’ll learn the benefits and impacts of validation and how it can benefit your customers and your business.  We’ll cover tools and techniques that can help you successfully validate your processes.

Areas Covered:

  • Purpose, scope, and benefits of process validation
  • Review common protocol types and the typical information included in each.
  • Common Deficiencies 
  • FDA Expectations, Regulations
  • Lessons Learned and Enforcement Case Studies
  • When to Verify and Validate
  • Process of Verification and Validation
  • Linkages to your Quality System.
  • Summarize Results
  • Master Validation Planning
  • Best Practices and Q n A with Attendees

Who Will Benefit: 

  • Medical Device Companies
  • Manufacturing Engineers
  • Process Engineers
  • Quality Engineers
  • Quality Assurance
  • Engineering Managers
  • Quality Managers
  • Quality Control
  • Production
  • Auditors
  • Equipment vendors
  • Compliance Specialists/ Regulatory.

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, Worldwide Director of Quality Engineering, Design Quality, and Director of Corporate Compliance.  

She has traveled extensively throughout the world helping companies understand and improve their Quality Management Systems.  Susanne is a Presidential Scholar and 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 is a Certified Quality Auditor by the American Society for Quality.  She has also served as a judge for the ASQ ITEA awards.  Susanne has now established a consulting business, Manz Consulting LLC, with a mission to provide services to help medical device companies achieve world-class quality and compliance.  

Available Options

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

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

$3,249

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

$4,429

Recording Access to 10 Members: 10 Participants can access the training Recording for 6 months from any location

$829

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

Validation and Control of Excel Spreadsheets in Regulated Environments

Validation and Control of Excel Spreadsheets in Regulated Environments

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.  USE COUPON “GRCTS10” TO AVAIL A 10% DISCOUNT Description: Excel Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation. Regulatio..

$235

Complaint Handling and Medical Device Reporting

Complaint Handling and Medical Device Reporting

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: Complaint Handling and Medical Device Reporting are considered critical processes by the FDA in maintaining the public safety. Because they are so critical the FDA frequently inspects these areas in great detail. M..

$249

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. 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 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 compone..

$259

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

How to Best Use Regulatory Pathways: ANDA and 505(b)(2)

How to Best Use Regulatory Pathways: ANDA and 505(b)(2)

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.Description: The United States Food and Drug Administration (FDA) approves news drugs and generic drugs under distinct regulatory pathways covered under Section 505 of the Federal Food, Drug and Cosmetic Act (FDCA or the Act). In this conference, the regulatory pathways, 505(b)2 for NDAs..

$259

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

Good Documentation Guideline (Chapter <1029> USP)

Good Documentation Guideline (Chapter <1029> USP)

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.Description: Good Documentation Practices (GDP) is a critical and essential part of a regulated environment (pharmaceutical and medical device manufacturing, R&D, laboratories and clinical trials). Compliance with GDP ensures an auditable account of work. It ensures integrity and con..

$169

How to Conduct a Human Factors/ Usability Validation

How to Conduct a Human Factors/ Usability Validation

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 explain the procedure described in ISO 62366 and the 2016 FDA Guidance for a compliant human factors/ usability validation. HF/U validation is very different from device validation. For example, success crite..

$259

21 CFR Part 820 - Quality System Regulation - Applying Principles of Lean Documents and Lean Configuration

21 CFR Part 820 - Quality System Regulation - Applying Principles of Lean Documents and Lean Configuration

The price for the recording is a discounted figure since the recording has a bit of static. The audio of the expert is loud and clear. However, due to static within the meeting. We are obligated to offer the recording at a discounted price. Please contact our support@grcts.com or click on chat below if you have any questions. Why should you attend:If you are constantly struggling to create, manage, and maintain all of the information found in controlled documents, all of which are often red..

$269

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

Preparation of FDA Submissions and Communicating with the FDA (INDs, NDAs, BLAs, ANDAs, PMAs, 510(k)s, IDEs, Post-Approval Supplements)

Preparation of FDA Submissions and Communicating with the FDA (INDs, NDAs, BLAs, ANDAs, PMAs, 510(k)s, IDEs, Post-Approval Supplements)

Background: Getting a drug, biologic or medical device approved by the FDA is one of the highest hurdles in the development process. This seminar covers current FDA regulatory compliance and the approval process with respect to developing and marketing drugs, biologics and medical devices. A focus will be placed on relevant aspects of FDA regulations and the practical aspects of bringing a medical product to market. The course will initially cover the general context for medical device regu..

$1269

Clinical Trial Management

Clinical Trial Management

This training is available for On Site and In Person SeminarWhy You Must Attend:This program will address the regulatory & legal requirements related to clinical trials and the sponsor responsibilities for effective management of clinical trials. Learn to identification & implement  systems to effectively select & manage vendors and clinical sites, and monitoring programs.Description:GCPs are required to be followed during conduct of clinical trials; it is the responsibili..

$1249

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

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

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

New Pharma Water System Project Details

New Pharma Water System Project Details

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 CertificateDescription:All Pharma Water systems have FDA established Standards for drug manufacturing. Included are Chemical and Microbial limits, Sampling, Testing, Materials, Records, Reports, In..

$389

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

Process Validation General Principles & Practices - FDA and EU Guidance; ICH Q8, ICH Q9, ICH Q10 and Quality Metrics

Process Validation General Principles & Practices - FDA and EU Guidance; ICH Q8, ICH Q9, ICH Q10 and Quality Metrics

This Training is available for On Site and Corporate TrainingCertifications: GRCTS Attendance CertificateIntegrating the FDA and EU Guidance; ICH Q8, ICH Q9, ICH Q10 and Quality Metrics”Description: ICH Q10, The Pharmaceutical Quality System, which was released to the international pharmaceutical industry in 2008, includes the concept of the product lifecycle.  Since that time, the lifecycle approach has been applied to all aspects of pharmaceutical products and processes.  ..

$809

Healthcare Compliance Program Effectiveness: Auditing and Monitoring

Healthcare Compliance Program Effectiveness: Auditing and Monitoring

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.  Description:  This webinar will discuss the best practices of implementing auditing and monitoring as a part of your compliance program. The U.S. Department of Health and Human Services (HHS) Office of Inspector General..

$469

The Impact of Final ICH GCP E6 R2 Guideline on Budgeting and Contracts in Globalization Environment: Changes Affecting Sponsors, CROs, Clinical Investigators, Sites.

The Impact of Final ICH GCP E6 R2 Guideline on Budgeting and Contracts in Globalization Environment: Changes Affecting Sponsors, CROs, Clinical Investigators, Sites.

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:      The ICH revised E6 guidelines was issued to reflect on the current research landscape: increases in globalization, study complexity, and tech..

$389

Mobile Medical Apps (is it regulated by FDA) & Cyber-Security

Mobile Medical Apps (is it regulated by FDA) & Cyber-Security

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 explain how to determine if your app is a medical device and if it will be subject to FDA requirements. The FDA approval process for a new app will be explained including FDA requirements for soft..

$459

Compliance Measures for Case Managers

Compliance Measures for Case Managers

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 Certificate Description:  This program will review the compliance issues that most greatly impact your practice such as the 2-midnight rule, the NOTICE Act, HINNs, the important messag..

$429

Verification or Validation of Methods in Food Microbiology

Verification or Validation of Methods in Food Microbiology

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@grcts.com for any clarifications. USE COUPON “GRCTS10” TO AVAIL A 10% DISCOUNT Description: This webinar will not only address the semantics but will also discuss the appropriate analytical and statistical approaches to achieving successful verification and validation studies with respect to food microb..

$259

The Disruptive Practitioner: A Danger to the Hospital's Operation

The Disruptive Practitioner: A Danger to the Hospital's Operation

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. Description: In this training program, attendees will discover how to create a record of disruptive behavior and the efforts taken by the organization to combat the problem. The webinar will also illustrate why such disruptive..

$169

Prepare & Submit Investigational New Drug (IND) and Investigational Device Exemptions (IDE) Applications and Conducting Meetings with FDA

Prepare & Submit Investigational New Drug (IND) and Investigational Device Exemptions (IDE) Applications and Conducting Meetings with FDA

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.  Description:  Submissions to a regulatory agency involve more than just writing of applications. They also encompass strategy, editing, publishing and systematic tracking of key information.  Through formal lecture..

$425