Pack of 3 Trending Courses on USP Standards

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  • Duration: 3 Hrs
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$599.00
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$899.00 $1,798.00 (50%)SAVE: $899.00
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Read Frequently Asked Questions

The GDP Chapter <1029> USP course will help you ensure an auditable account of work, integrity, and control of documents which is a key requirement for a developed quality system. The Analytical Instrument Qualification Chapter <1058> USP course will help you understand what exactly to qualify or re-qualify test, and document. In the Transfer of Analytical Methods Chapter <1224> USP training, you will learn to select the most appropriate and efficient method transfer approach for a given situation, understand the potential risks involved in the method transfer process, and the importance of identifying and mitigating them.

We understand that you need to be well-informed. So, we have compiled the following 3 Trending Courses on GDP, Analytical Instrument Qualification, and Transfer of Analytical Methods to help you understand compliance.

All Modules:

Module 1: Transfer of Analytical Methods according to USP <1224>
Module 2: Good Documentation Guideline (Chapter <1029> USP)
Module 3: Understanding and Implementing USP <1058>: Analytical Instrument Qualification

Part 1 : Transfer of Analytical Methods according to USP <1224>
Instructor: Mark Powell

Areas Covered in the Webinar:

  • Method transfer approaches
  • Setting appropriate acceptance criteria
  • Preparing for method transfer
  • Is the method suitable?
  • Managing risk in the method transfer process
  • Common method transfer problems
  • Contingency planning in the event of method transfer failure
  • A risk-based approach to method transfer documentation

Part 2 : Good Documentation Guideline (Chapter <1029> USP)
Instructor: Dr. Afsaneh Motamed Khorasani

Areas Covered in the Webinar:

US Pharmacopeia General Chapter <1029>:

  • History of the chapter as to how and why it was created
  • Purpose of development of this chapter
  • Chapter outline:
    • Principles of Good Documentation
    • Data collection & recording
    • Different types of GMP Documents:
    • Laboratory records
    • Equipment-related documentation
    • Deviations and investigations
    • Batch records
    • Certificate of Analysis (C of A)*
    • Standard Operating Procedure (SOP)*
    • Protocols & reports*
    • Analytical procedures*
    • Training documentation
  • Retention of documents

Part 3 : Understanding and Implementing USP <1058>: Analytical Instrument Qualification
Instructor: Dr. Ludwig Huber

Areas Covered in the Webinar:

  • FDA and EU requirements for analytical instrument qualification.
  • Most common inspection problems.
  • Terminology, scope and principles of the new USP chapter.
  • AIQ and its relation to method validation, system suitability testing and quality control checks.
  • Essential steps for AIQ: DQ, IQ, OQ, PQ
  • Purpose and contents of equipment qualification phases: design qualification, installation qualification, operational qualification, performance qualification.
  • Recommendations for firmware and software validation.
  • Roles and responsibilities: QA, manufacturer, user.
  • Approach for automated systems (incl. firmware/computer systems).
  • Requalification after equipment changes (move, repair, firmware upgrade, hardware upgrade).
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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 [email protected] call +1-888-717-2436 (Toll Free).

 

 

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