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>
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).
Course Provider
Dr. Afsaneh Motamed Khorasani,
