Fill your Library with Dr. Ludwig Huber's Laboratory Compliance Trainings

Laboratories have to consider various aspects in order to ensure continuing compliance with FDA regulations which themselves are updated regularly. Labs, therefore, have to put in place compliance programs that can be adapted quickly to changing regulatory requirements and make sure that FDA citations or warning letters are avoided.

This package of six webinar recording CDs covers concepts such as bioanalytical methods and procedures for FDA compliance; calibration and qualification in analytical labs; verification of compendia methods according to the revised USP Chapter <1226>; understanding and implementing ISO 17025; lab data security; and transfer of analytical methods as described in USP Chapter <1224>.

How It Works:

Each webinar CD has a series of modules. Our speakers have delivered the modules using PowerPoint slides.

This training is convenient to attend individually or in groups. You don’t have to travel from your office. This means you can afford to have your whole team attend. As the webinar recording CDs are licensed to be used multiple times in a location, you can schedule the training as many times for as many groups/batches as you wish. Your team members will learn the material together; everybody will get the same information.

About the Instructor:

Ludwig Huber, Ph.D., is Director of Labcompliance and Chief Advisor for global FDA compliance for Agilent Technologies. He is the editor of www.labcompliance.com, the global on-line resource for validation and compliance issues for laboratories. He is the author of the books “Validation and Qualification in Analytical Laboratories, and "Validation of Computerized Analytical and Networked Systems", Informa Healthcare.

Webinar Topics:

Module 1: Validation of Bioanalytical Methods and Procedures for FDA Compliance
Module 2: Calibration and Qualification in Analytical Laboratories
Module 3: Verification of Compendial Methods According to the Revised USP Chapter <1226>
Module 4: Understanding and Implementing ISO 17025
Module 5: Ensuring Integrity and Security of Laboratory Data
Module 6: Understanding the New USP Chapter <1224> for Transfer of Analytical Methods

Who will Benefit?

These webinar recording CDs will be beneficial to the following:
Lab Supervisors and Managers; QA managers and personnel; GLP auditors; GLP study directors; Analysts; Consultants; Teachers; Pharmaceutical Research; Pharmaceutical development; Contract laboratories; and CROs.

Webinars Iincluded in the Package:

Module 1 : Validation of Bioanalytical Methods and Procedures for FDA Compliance (Duration: 75 minutes)

This compliance training webinar will demonstrate how to validate bioanalytical methods and procedures in analytical laboratories for FDA compliance.

Areas Covered in the Seminar:

• FDA regulations and guidelines.
• Understanding the FDA and EMA Guidances for Bioanalytical Method Validation.
• Phased approach for validation during drug development.
• Logistics of validation.
• Development of a master plan and SOP for validation.
• Preparation and use of reference standards and equipment.
• Defining parameters and acceptance limits.
• Defining validation experiments.
• Documenting and archiving raw and source data.
• Considerations for Microbiological and Ligand-binding Assays.
• Working with QC samples for quantitative routine analysis.
• To revalidate or not after method changes.
• Transferring and using the method to routine.
• Using computers for automated method validation.
• Documentation for the FDA and other agencies.

Module 2 : Calibration and Qualification in Analytical Laboratories (75 Minutes)

This webinar will provide a detailed understanding about calibration and qualification of laboratory equipments, development of a qualification master plan, allocation of equipments to qualification categories A, B, C, and the approach for qualifying existing systems.

Areas Covered in the Seminar:

• Operational lab equipment requirements for calibration and qualification.
• Most common inspection problems.
• USP Chapter <1058>: Analytical Instrument Qualification.
• Development of an effective equipment qualification master plan.
• Calibration/qualification phases: design qualification, installation qualification, operational qualification, performance qualification.
• Allocating equipment to qualification categories A, B and C.
• Qualification and documentation requirements for each category.
• Going through the category example list.
• Approach for existing systems.
• Approach for automated systems (incl. firmware/computer systems).
• Requalification after equipment changes (move, repair, firmware upgrade, hardware upgrade).
• Documentation requirements.

Module 3 : Verification of Compendial Methods According to the Revised USP Chapter <1226> (75 minutes)

This webinar on verification of compendial methods will give a good understanding of the revised USP Chapter <1226> and FDA requirements and provide recommendations and tools for effective implementation.

Areas Covered in the Seminar:

• What are FDA and international requirements for compendial methods?
• What and how much should be tested?
• How to use the risk based approach?
• Is system suitability testing enough?
• Do all compendial routine methods require verification?
• When could just system suitability testing be enough?
• Should we verify all performance characteristics?
• How much can we deviate from the compendial method without the need for a full revalidation?
• What to do if the compendial procedure cannot be verified?
• How frequently should compendial methods be re-verified?
• What if our equipment was not included in the USP method validation experiments.

Module 4 : Understanding and Implementing ISO 17025 (75 minutes)

This webinar will provide detailed information on the critical requirements of ISO 17025 and recommendations for cost effective implementation. You will learn steps towards laboratory accreditation and how to prepare for an ISO 17025 audit.

Areas Covered in the Seminar:

• Benefits of ISO 17025.
• Management requirements.
• Technical requirements.
• Documentation requirements.
• Steps towards ISO 17025 laboratory accreditation.
• ISO 17025 and agencies, such as US FDA.
• Impact on Analytical Laboratories.
• Recommendations for implementation.
• Dealing with multiple quality systems.
• Preparation for an ISO 17025 Audit.
• Local and global resources.

Module 5 : Ensuring Integrity and Security of Laboratory Data (75 minutes)

This webinar will provide a comprehensive understanding of the key FDA/EU requirements for integrity and security of laboratory data and offer recommendations and tools for effective implementation.

Areas Covered in the Seminar:

• Eight key FDA/EU requirements for integrity and security of laboratory data.
• How FDA inspectors check integrity and security of data.
• Most frequent security and integrity issues: going through recent 483's, EIRs and warning letters?
• The importance of limited access to 'individual users' rather than to groups.
• FDA compliant definition, acquisition, maintenance and archiving of raw data.
• Critical integrity and security issues during the entire life of laboratory data: from data acquisition through evaluation to archiving.
• Examples how to ensure and document data integrity.
• Documenting changes of laboratory data: paper, hybrid systems, electronic.
• The importance of electronic audit trail to document data integrity.
• Review of electronic audit trail: who, what, when and how.
• Ensuring timely availability through validated back-up and archiving.
• Going through representative 10 case studies: FDA observations, complete responses to each observation, corrective actions and preventive actions.

Module 6 : Understanding the New USP Chapter <1224> for Transfer of Analytical Methods (75 minutes)

This webinar will explain the final version of USP Chapter <1224> and FDA guidance for conducting and documenting method transfer between laboratories and sites, and provide tools for effective implementation.

Areas covered in this webinar:

• FDA and International expectations for method transfer.
• Examples of FDA warning letters and how to avoid them.
• The FDA Guidance on method transfer.
• The new USP chapter <1224>: history, status, future.
• Four approaches for analytical method transfer and testing.
• Responsibilities of the transferring and receiving laboratory.
• Developing a transfer plan and a pre-approval protocol.
• Conducting comparative studies.
• Criteria and approaches for risk based testing: what, when, how much?
• The importance and selection of acceptance criteria.
• Dealing with technology transfer: validation requirements, regulatory notification.
• Method transfer from standard HPLC to UHPLC.
• Most likely failures during method transfer.
• Handling deviations from documented acceptance criteria.
• Criteria for transfer waiver (omission of formal transfer).
• Method transfer protocol and summary report.

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