Key Trainings to Improve Quality and Safety in Laboratory

ComplianceOnline has created these trainings individually through world renowned experts and combined together to create a comprehensive course for companies to train their employees. You can store it as a “Quality and Safety in Laboratory” and train all your employees in these compliance issues to get them ready for facing any kinds of compliance challenges and overcome it through expert advice and best practices.

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All Modules:

Module 1: Understanding the New USP Chapter <1224> for Transfer of Analytical Methods
Module 2: Verification of Compendial Methods According to the Revised USP Chapter <1226>
Module 3: Managing GLP Studies in Non-GLP Facilities
Module 4: Calibration and Qualification in Analytical Laboratories
Module 5: Validation of Bioanalytical Methods and Procedures for FDA Compliance
Module 6: Auditing the QC Microbiology Laboratory for FDA Compliance
Module 7: System Based Inspections - Laboratory Controls
Module 8: Ensuring Integrity and Security of Laboratory Data
Module 9: New QC Based on Risk Management: A Collaboration between CLIA and CLSI
Module 10: Test Article Management and Characterization for Drugs and Devices

Module 1 : Understanding the New USP Chapter <1224> for Transfer of Analytical Methods
Instructor: Dr. Ludwig Huber

Free Hand-outs:

For easy implementation, attendees will receive

• SOP: Transfer of Analytical Methods
• Checklist: Transfer of Analytical Methods and Procedures
• Master Plan template and examples: - Transfer of Analytical Methods and procedures

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.

Module 2 : Verification of Compendial Methods According to the Revised USP Chapter <1226>
Instructor: Dr. Ludwig Huber

Hand-Outs:

For easy implementation, attendees will receive

• SOP: Verification of Compendial Methods
• Checklist: - Verification of Compendial Methods
• Case Studies; Verification of Compendial methods and Procedures

Note: These complimentary hand-outs will be sent to customers on request. Please email [email protected] for these documents, stating your order number, and they will be emailed to you within 4 working days.

Learning Objectives:

• 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 3 : Managing GLP Studies in Non-GLP Facilities
Instructor: Anne Maczulak

Areas Covered in the Seminar:

• What constitutes a GLP study?
• What are the biggest risks in mixing GLP and non-GLP work in the same facility?
• How to separate GLP from non-GLP reagents
• How to keep test articles and reference standards away from non-GLP
• How to divide labs into GLP and non-GLP zones
• How to identify testing facility management
• How to train graduate students, interns, etc., in GLP
• What goes into the compliance statement when non-GLP activities are part of a GLP study?

Module 4 : Calibration and Qualification in Analytical Laboratories
Instructor: Dr. Ludwig Huber

Hand-Outs:

For easy implementation, attendees will receive

• 4 SOPs
  • User Requirement Specifications (URS) for analytical equipment
  • Change control for analytical equipment
  • Qualification of equipment
  • Allocating Analytical Instruments to USP <1058> Categories
• 20+ Examples for Instrument OQ Testing

Note: These complimentary hand-outs will be sent to customers on request. Please email [email protected] for these documents, stating your order number, and they will be emailed to you within 4 working days.

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 5: Validation of Bioanalytical Methods and Procedures for FDA Compliance
Instructor: Dr. Ludwig Huber

Free Handouts:

For easy implementation, Attendees will receive:

• SOPs: Validation of Bioanalytical Methods
• Checklist: - Validation of Bioanalytical Methods
• Master Plan Template with Examples: Validation of Bioanalytical Methods
• FDA Guidance and Policy: Bioanalytical Method Validation
• New EMA Guideline on Bioanalytical Methods Validation

Note: These complimentary hand-outs will be sent to customers on request. Please email [email protected] for these documents, stating your order number, and they will be emailed to you within 4 working days.

Learning Objectives:

• 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 6 : Auditing the QC Microbiology Laboratory for FDA Compliance
Instructor: Chitra Edwin

This webinar will be a comprehensive overview of Auditing of a Microbiology Laboratory for QC compliance.

• The following topics will be addressed:
  • Infrastructure of a Microbiology Testing Laboratory.
  • Test Methods and Validation.
  • Equipment.
  • Documentation.
  • Preparation for inspections.
  • Corrective Actions.
  • Preventive Actions.

Module 7 : System Based Inspections - Laboratory Controls
Instructor: John G Lanese

Areas Covered in the Seminar:

• What is a Systems Based Inspection.
• Why FDA moved to Systems Based Inspections.
• What is different from the old inspectional techniques.
• What is the Laboratory Control System.
• Has the new technique changes the findings?
• What are the responsibilities of the various units in the organization.
• What are the specific things the FDA is looking at.
• What other changes can be anticipated in FDA inspections.

Module 8 : Ensuring Integrity and Security of Laboratory Data
Instructor: Dr. Ludwig Huber

Complimentary Hand-outs:

For easy implementation, attendees will receive

• SOP: Integrity and Security of Electronic Laboratory Data.
• Checklist: Security and Integrity of Electronic Data.
• SOP: Electronic Audit Trail - Specification, Implementation, Validation.
• 10 Case studies: FDA observations, complete responses to each observation, corrective actions and preventive actions.

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 9 :New QC Based on Risk Management: A Collaboration between CLIA and CLSI
Instructor: Pamela Tayon Colker

Areas Covered in the Seminar:

• Developing this new QC Plan based on Risk Management.
• Where to collect data and information for quality monitors?
• Definition of Risk Management Principals.
• Review of the Lab environment and the clinical application of test results.
• How to use this data to detect trends, identify corrective actions, and promote CQI?
• Pros and cons of the various tools in the Guideline.

Module 10 : Test Article Management and Characterization for Drugs and Devices
Instructor: Anne E Maczulak

Areas Covered in the Seminar:

• What are the recommended procedures for chemical and physical characterization of drugs/devices in safety testing.
• What are the basic requirements of test article characterization.
• How to manage carry-over from test to control article
• How to use GMP test article characterization and the certificate of analysis for a GLP study
• How to define a device test article
• How to characterizing medical devices
• Stability testing for drugs and devices
• How to document test article usage and distribution

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