Validation of Analytical Methods according to the New FDA Guidance

  • Speaker:Ludwig Huber
  • Duration:75Min
  • Product Code:GRC-90253

$279

refer

Refer Friends


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. You can access the recording of the webinar for 6 months. Contact our support for any clarifications. 

Description:

FDA has released a new comprehensive guidance for validation of analytical methods. The guidance follows the modern integrated lifecycle approach with related new requirements for using quality-by-design components, risk assessment, design space and continuous improvement. The guidance will significantly change the way how FDA regulated methods will be developed, validated and used. Because of the novelty of some of the concepts the industry has difficulties to understand and implement the guidance. Attendees of this seminar will understand and learn how to implement the new guidance.

Topics

  • Key differences to the existing guidance 
  • Scope and content of the guidance
  • Going through validation parameters, tests, and acceptance criteria
  • Comparison with ICH Q2
  • How to apply the lifecycle management for analytical procedures
  • When and how to periodic review and revalidate methods
  • Analytical method comparability studies for alternative methods
  • Recommendations analytical method transfer studies
  • Development experiments that should be conducted under GMP conditions
  • Application of QbD components: design space, multivariate experiments, risk assessment

Handouts:

  • Standard Operating Procedure - Validation of Analytical Methods
  • Transfer of Analytical Methods
  • Verification of Compendial Methods

Who will benefit (by Function)

  • QC managers
  • QA managers and personnel 
  • Laboratory managers and supervisors
  • Analysts
  • Regulatory affairs
  • Training departments
  • Documentation department
  • Consultants

Instructor Profile:

Ludwig Huber, Ph.D., is the director of Labcompliance. The global online resource for validation and compliance. He is the author of the books "Validation and Qualification in Analytical Laboratories" and "Validation of Computerized Analytical and Networked Systems". He has given multiple presentations mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world. This included seminars, workshops and presentations for the US FDA, China CFDA, ISPE, PDA, PIC/S and several other industry organizations and national health care agencies.

Available Options

Recording: Access the training Recording for 6 months from any location

$279

CD: Shipped within 2 working days

$389

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

$2,249

10 Member group: 10 can Attend Live Meeting Online from any location globally

$3,469

Related Products

FDA Requirements for Computer System Validation

FDA Requirements for Computer System 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: The validation of computer system has been an FDA requirement since more than 20 years. Nevertheless companies have problems with implementation. This is proven through many FDA warning letters related to software an..

$289

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

Validation and Use of Cloud Computing in FDA Regulated Environments

Validation and Use of Cloud Computing in FDA Regulated Environments

Description:Cloud computing can significantly reduce investment and operating costs for IT operations. However when used in FDA and other regulated environments they need to be validated to ensure consistent on-going performance and security and integrity of stored and managed data. While there are guidelines available on how to deal with standard networks this is not the case for virtual networks and cloud computing, This seminar will give a good understanding of FDA requirements of cloud compu..

$269

Auditing Quality Suppliers and Vendors

Auditing Quality Suppliers and Vendors

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 various regulatory agencies have expectations that pharmaceutical manufacturers will demonstrate control over their manufacturing processes, validations, and documentation. Quality auditing is the process of checking..

$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

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