Post Learning Implementation Plan (PLIP)

Pre-course

• Access to the Educo Training Portal
• Submit your needs analysis and objectives for training by completing a simple online form

Action Plan

• At the end of the training you will create an action plan to help you implement and develop your new skills and knowledge

Reinforcement Session

• Delivered 3 to 4 weeks after the training
• It is a 1 hour virtual session enabling the group to reinforce the key learnings from the training and cover and subsequent questions and challenges

Day 1

Requirements and approaches for Analytical Instrument Qualification

• FDA/EU, PIC/S requirements
• Qualification/calibration issues in FDA inspections
• USP General Chapter <1058>: Analytical Instrument Qualification
• The instrument qualification lifecycle
• Prioritizing calibration/qualification activities

Qualification in Practice

• User requirement specifications
• Installation qualification
• Operational qualification
• Preparing inspection-ready documentation

Testing and deviation handling

• Developing test protocols
• Documenting test evidence
• Review and approval of test results
• Handling deviations

Retrospective qualification and Requalification

• Qualification of existing systems
• Leveraging past experience
• Time-based requalification
• Event-based requalification
• What and how much to test – risk-based approach

Equipment Maintenance and Change control

• Preventive maintenance; tasks, documentation
• Planned and unplanned changes
• Changing hardware, firmware, documentation
• Definition and handling of like-for-like changes.
• Handling changes made by vendors

Type and extend of qualification for USP Instrument Categories

• The approach and benefits of instrument categories
• How to identify the correct category: A, B, C
• Type and extent of qualification for each category
• Required procedures and qualification deliverables
• Responsibilities for instrument qualification

Requirements and approaches for GMP Computer Systems

• 21 CFR Part 211, Part 11, PIC/S, EU Annex 11
• Recent inspection findings
• Which systems need to be validated
• GAMP 5: A Risk based Approach to Laboratory Computerized Systems
• Examples for risk assessment of computer systems

Validation of Laboratory Computer systems

• Writing a validation project plan
• Integrating GAMP 5 with USP <1058> for instrument and computer system validation
• Writing a validation report

Day 2

Validation and Use of Excel in the QC Laboratory

• Designing spreadsheets for compliance
• Validation approach for spreadsheets – single and multiple-use spreadsheets
• When, what and how much to test?
• GAMP 5 recommendations
• How to ensure spreadsheet data integrity

Configuration management and change control

• Configuration management standards
• The change control process for planned changes
• Unplanned changes
• Upgrading software
• What to test after changes?
• How to document changes

Periodic revalidation of chromatography data systems

• The approach and practice of periodic review
• Using periodic review to reduce frequency of revalidation
• Criteria for time-based revalidation
• Incidents requiring revalidation
• Validation tasks after installing security and other patches

Handling raw data and other laboratory records

• Definition of raw data: electronic vs. paper
• Acquisition and recording of raw data
• How to make accurate and complete copies of raw data
• Changing records
• Archiving of raw data and ready retrieval

Ensuring Integrity and Security of GMP data

• Most frequent security and data integrity issues
• The importance of electronic audit trails
• Review of electronic audit trails: who, what, when and how

Auditing Laboratory Computer Systems

• FDA inspection practice
• Importance of data governance policy and controls
• Preparing inspection-ready documentation
• Responding to typical inspectional/audit observations

Dr. Mark Powell is a Fellow of the Royal Society of Chemistry (RSC) with over 30 years’ experience as an analytical chemist. In 2003, he helped to set up a UK-based contract research and manufacturing company specialising in early-stage drug development, where he ran the analytical development programme. His responsibilities included commissioning and validating laboratory data systems and training staff.

In 2013, he set up his own company which offers training and consultancy services to the pharmaceutical industry. These include guiding the CMC aspects of drug development programmes and training in areas such as chromatography, dissolution testing, data integrity, method development/validation, analytical instrument qualification, technical writing and auditing.

Mark not only brings a huge amount of knowledge and experience to his workshops but excellent at delivering interactive and engaging courses with multiple examples throughout.