ComplianceOnline

Validation of Analytical Methods According to the New FDA Guidance

Instructor: Dr. Ludwig Huber
Product ID: 703623
  • Duration: 75 Min

recorded version

$229.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Apr-2015

Training CD

$399.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-565-8542

Email: customercare@complianceonline.com

Read Frequently Asked Questions

This webinar will elaborate the scope and content of the recent FDA guidance on validation of analytical methods. The webinar will also illustrate the lifecycle management of analytical procedures and train attendees on documentation requirements and verification of submitted methods.

Why Should You Attend:

Recently the FDA has released a new comprehensive guidance for validation of analytical methods. The guidance applies 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 how FDA regulated methods will be developed, validated and used. Since these concepts are fairly new, the industry has difficulties in understanding and implementing the guidance. Through this webinar, attendees will learn everything about the background and principles of the guidance.

Participants will also receive effective hand-outs that include checklists and samples of validation reports. The webinar will focus on detailing all key components of the guidance and analyze its validation parameters, tests, and acceptance criteria.

Hand-outs:

For easy implementation, attendees will receive:

  • Checklist: Validation of Analytical Methods According to the FDA Guidance 2014
  • SOP: Validation of Analytical Methods
  • Example: Validation Report for Analytical Methods

Note: These complimentary hand-outs will be sent to customers on request. Please email customercare@complianceonline.com for these documents, stating your order number, and they will be emailed to you within 4 working days.

Areas Covered in the Webinar:

  • Scope and content of the guidance
  • Going through validation parameters, tests, and acceptance criteria
  • Comparison with ICH Q2
  • Lifecycle management of analytical procedures
  • Periodic review and revalidation
  • Analytical method comparability studies for alternative analytical procedures
  • Analytical method transfer studies
  • Development experiments that should be conducted under GMP conditions
  • Application of QbD components: design space, multivariate experiments, risk assessment
  • Documentation requirements
  • Verification of submitted methods at the FDA
  • Reporting post-marketing changes to an approved method

Who Will Benefit:

  • Personnel from the pharmaceutical and medical device industry
  • Manufacturers of drug substances (APIs)
  • Contract laboratory staff
  • Laboratory managers and staff
  • Analysts
  • QA managers and personnel
  • Regulatory affairs personnel
  • Training department personnel
  • Documentation department personnel
  • Consultants
  • Validation specialists

Instructor Profile:

Dr. Ludwig Huber, Ph.D., is the director of Labcompliance and editor of www.labcompliance.com, the global online resource for validation and compliance. He has authored 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 includes seminars, workshops and presentations for the US FDA, China SFDA, Korea MFDS, Singapore HSA, ISPE, Japan PDA, PIC/S and several other national healthcare agencies.

Follow us :
eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada
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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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