Training Programs by Dr. Ludwig Huber: (30+ Years of Experience in Lab Compliance and Analytical Method Validation)

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Why Should You Attend:

Very few have influenced the day-to-day management of regulatory compliance in the field of lab compliance, and analytical method validation more than Dr. Ludwig Huber. A prominent, sought-after author, and trainer, Dr. Ludwig Huber is respected for his groundbreaking sessions in "Computer System Validation and Part 11/Annex 11 Compliance", "GMP Compliance for Quality Control and Contract Laboratories", "Analytical Method Validation, Verification and Transfer", "Analytical Instrument Qualification and System Validation" and "Validation and Part 11 Compliance in Laboratories".

On this page, get access to his on-demand training programs. CDs/USBs of his programs are also available for shipment. Benefit from the breadth and depth of Dr. Ludwig Huber’s experience. Learn how to comply with FDA and with quality standards like ISO/IEC 17025 and other regulations.

Course 1: Calibration and qualification in analytical laboratories (75 Mins)
Course 2: Transfer of analytical methods according to the USP chapter <1224> (75 Mins))
Course 3: Understanding and implementing USP <1058>: Analytical Instrument Qualification (75 Mins)
Course 4: Validation and use of cloud computing in FDA regulated environments (75 Mins))
Course 5: Ensuring integrity and security of laboratory data (75 Mins)
Course 6: Learning from recent FDA warning letters related to part 11 and computer validation (75 Mins)
Course 7: Good laboratory practice regulations (75 Mins)
Course 8: System Suitability Testing (SST) for USP and FDA compliance (75 Mins)
Course 9: Computer system validation: step-by-step (75 Mins)
Course 10: Validation, verification and transfer of analytical methods – Implementing Guidelines from FDA/EMA, USP and ICH (180 Mins)
Course 11: Validation and use of excel® spreadsheets in FDA regulated environments (75 Mins)

Calibration and Qualification in Analytical Laboratories (75 Mins) Areas Covered in the Webinar:
  • 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
Top
Transfer of Analytical Methods According to the USP Chapter <1224> (75 Mins) Areas Covered in the 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.
Top
Understanding and Implementing USP <1058>: Analytical Instrument Qualification (75 Mins) 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).
Top
Validation and Use of Cloud Computing in FDA Regulated Environments (75 Mins)( Areas Covered in the Webinar:
  • Benefits of virtual networks and cloud computing
  • Possible issues when used in FDA regulated environments
  • Recommendations from official task forces
  • Different models: infrastructure, platform and software as a service
  • Recommendations for different cloud versions: internal/external private, public
  • Validation of cloud vs. traditional computers
  • How to deal with major issues: security, data availability and data integrity
  • Going through a complete project for cloud computing validation
  • Selecting the right cloud provider for compliance
  • What and how much to test and documents for different cloud models
  • Considerations for formal agreements with service providers
  • Step-by-step recommendations for using 'clouds' from planning to reporting
  • Putting everything together: documentation for the FDA and every other agency
  • Sharing best practices
Top
Ensuring Integrity and Security of Laboratory Data (75 Mins) Areas Covered in the Webinar:
  • 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
Top
Learning from Recent FDA Warning Letters Related to Part 11 and Computer Validation (75 Mins) Areas Covered in the Webinar:
  • FDA inspections - preparation, conducts, follow up
  • The meaning of Warning Letters and 483 inspectional observations
  • Learning from an FDA presentation: Data Integrity and Fraud - Another Looming Crisis?
  • Data integrity and authenticity: FDA's new focus during inspections
  • Examples of recent Part 11 related 483s and Warning Letters
  • Examples of recent 483s and Warning Letters related to computer system validation
  • Most obvious reasons for deviations
  • Avoiding and responding to 483s: going through case studies
  • Writing corrective and preventive action plans as follow up to 483s
  • Using internal audits to prepare yourself for Part 11 related FDA inspections
  • Strategies and tools for compliant Part 11 implementation
  • The future of Part 11 and computer system validation
Top
Good Laboratory Practice Regulations (75 Mins) Areas Covered in the Webinar:
  • FDA and International GLP regulations: 21 CFR Part 58, OECD
  • Objectives and concepts of GLP's
  • Special organizational requirements
  • Responsibilities: Management, Study director, QA, analysts
  • SOP requirements: type, formats and enforcement
  • GLP studies: preparation, conduct, documentation
  • Key requirements for equipment, facilities reference material, people
  • 21 CFR Part 11 compliant generation, evaluation and archiving of raw data, intermediate results, final results
  • Records keeping: format, length of time, archiving and reprocessing
  • Preparing for FDA inspections
Top
System Suitability Testing (SST) for USP and FDA Compliance (75 Mins) Areas Covered in the Webinar:
  • FDA and international requirements for system suitability testing
  • Examples of FDA warning letters and how to avoid them
  • The role of SST for analytical quality assurance
  • SST in comparison with equipment qualification and quality control sample analysis
  • Most critical parameters for SST in EP and USP
  • Contents of the updated USP chapter <621>
  • Recommendations for implementing the updated <621>
  • Developing an SOP for system testing
  • Criteria for SST timing within a sequence of sample runs
  • Using software for automated system suitability control
  • The role of SST for method changes according to the updated chapter <621>
  • Case studies with practical advice for test parameters and limits
  • Documenting SST test runs
Top
Computer System Validation: Step-by-Step (75 Mins) Areas Covered in the Webinar:
  • US FDA and EU requirements and enforcement practices
  • Learning from recent FDA 483s and Warning Letters
  • Selecting the right validation model: qualification vs. verification
  • Eight fundamental steps for computer system validation
  • Structure and example of a validation plan
  • Justification and documentation of risk levels
  • Examples of qualification document for suppliers of commercial systems
  • Examples for requirement and functional specifications
  • Example for IQ protocols
  • OQ test protocols: development, execution, approval - examples
  • Documentation of ongoing performance
  • Validation of existing systems
  • Structure and example of a validation report
  • Step-by-step case studies from laboratories and manufacturing units for easy implementation
Top
Validation, Verification and Transfer of Analytical Methods – Implementing Guidelines from FDA/EMA, USP and ICH (180 Mins) Areas Covered in the Webinar:

Part 1: Regulatory background and requirements

  • FDA and international requirements
  • The importance of ICH Q2 and USP chapters
  • USP approach for method validation: USP Chapters 1220, 1224, 1225, 1226
  • Learnings from the NEW FDA and WHO method validation guidelines
  • Different method validation requirements for GLP, GCP and GMP
  • The importance and steps of risk assessment for testing validation parameters
  • Exercise: Define risk numbers for different methods
  • Method revalidation and ongoing performance review
  • Lessons from recent FDA inspections and Warning Letters
  • Lifecycle approach and Quality by Design (QbD) for method development and validation

Part 2: Validation of analytical methods and procedures

  • Developing a validation plan and SOP
  • ICH Q2 and USP 1225 validation and test parameters:
    • Accuracy, precision, intermediate precision, specificity, LOD, LOQ, linearity, range, robustness, ruggedness
  • Examples for application specific acceptance criteria
  • Examples for design and execution of test experiments
  • Handling deviations from expected test results
  • Going through an example validation report

Part 3: Verification of compendial and transfer of analytical methods

  • FDA and equivalent international expectations
  • Scope and objectives of USP <1226>
  • USP <1226> verification requirements
  • Risk based approach for type and extent of verification testing
  • The main objective of formal method transfer
  • Learnings from EU GMP Chapter 6 or method transfer
  • USP <1224> : Choosing the approach for transfer
  • Approach and benefits of comparative testing:
  • Developing a risk based test plan
Top
Validation and Use of Excel® Spreadsheets in FDA Regulated Environments (75 Mins) Areas Covered in the Webinar:
  • US FDA and EU requirements and enforcement practices
  • Learning from recent FDA 483s and Warning Letters
  • Selecting the right validation model: qualification vs. verification
  • Eight fundamental steps for computer system validation
  • Structure and example of a validation plan
  • Justification and documentation of risk levels
  • Examples of qualification document for suppliers of commercial systems
  • Examples for requirement and functional specifications
  • Example for IQ protocols
  • OQ test protocols: development, execution, approval - examples
  • Documentation of ongoing performance
  • Validation of existing systems
  • Structure and example of a validation report
  • Step-by-step case studies from laboratories and manufacturing units for easy implementation
Who Will Benefit:
  • FDA and other agency’s requirements for spreadsheet validation - What do inspectors ask and what documents should be available.
  • How to design spreadsheets for Part 11/GxP/SOX/HIPAA compliance?
  • Validation during design, development, installation and on-going use.
  • When, what and how much to test?
  • Dealing with standard Excel functions: Recommendations from GAMP5.
  • How to ensure and validate spreadsheet integrity and security for GxP and Part 11?
  • How to apply risk based validation to spreadsheet applications?
  • Validation of 'ad hoc' spreadsheet applications.
  • How to document planning, specifications, installation, testing and changes?
  • Examples from manufacturing, laboratories and offices.
Instructor Profile:
Dr. Ludwig Huber Dr. Ludwig Huber

Director and Chief Editor, Labcompliance

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

Dr. Ludwig Huber - Awards and Recognitions
  • Winner of the Wallhaeusser award, sponsored by the European Compliance Academy. The award is for publications in the area of 'Quality and Safety of Drugs'
  • Winner of the "First International GLP Award" from Indian Drug Manufacturer Association for Publications and Presentations in the Area of GLP and GMP
  • IVT's Presenter of the Year, selected from 170 presenters.
Praises
  • The course was helpful in reviewing change control requirements. I have limited prior experience with computer validation. The examples discussion from other participants was the most beneficial aspect. The opportunity to glean more detailed, technical assessment from an experienced person helps me with my own decision-making skills - Anonymous
  • Information presentations and handouts helpful. - Anonymous
  • The presentation gave useful, real-life examples. a definite A+.
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. FDATrainingAlert 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.

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