Pack of 3 Trending Courses on USP Standards

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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