Validation and Part 11 Compliance of Computer Systems and Data at Zurich, Switzerland

Overview:

Analytical equipment should be qualified and computer systems should be validated to demonstrate suitability for the intended use. Electronic records must comply with FDA Part 11 and EU/PICS GMP Annex 11 requirements to ensure data integrity, security and availability. Recent EU and FDA inspection documents prove that qualification, validation and electronic laboratory are records are on target of inspectors. The large number of warning letters issued to laboratories also demonstrate that they struggle with either understanding or implementing the regulations.

This 2-day course provides the regulatory background and guides attendees through the complete equipment qualification, calibration and computer system validation processes from planning to reporting. It also helps to fully understand Part 11 and Annex 11 requirements to ensure and document integrity and other requirements for electronic records and signatures.

The 2-day course not only ensures a full understanding of the regulations and guidelines for equipment and records but also provides templates and examples to develop inspection ready documentation. Interactive exercises will be dispersed into and between the presentations. About 50% of the total time will be dedicated to practical sessions. Here attendees work in small groups on case studies and prepare the answers using prepared fill-in templates. After the course a large variety of tools such as SOPs, validation examples and checklists will be readily available on a dedicated website that can be used to easily implement what they have learned in the course.

Additional Bonus Material for easy implementation:

70-page primer Analytical Instrument Qualification and System Validation (authored by Dr. Ludwig Huber)

10 SOPs related to validation and qualification of analytical equipment and computer systems. change control, risk assessment, maintenance, security and integrity of electronic records

Full Set of Qualification examples for an HPLC system Full set of Validation examples of a chromatographic Data System

Why should you attend?

• Learn about the regulatory background and requirements for equipment qualification according to USP <1058>, computer system validation according to GAMP Guides
• Learn how to ensure and document integrity of raw data and other records according to Part 11 and Annex 11
• Be able to explain the difference between equipment calibration, qualification and system validation
• Understand and Implement the new UK MHRA GMP Data Integrity Guideline
• Learn which equipment/systems need to be qualified or validated
• Be able to allocate equipment and systems to USP <1058> and GAMP categories and to design and execute qualification/validation protocols accordingly
• Understand the logic and principles of instrument qualification and system validation from planning to report
• Be able to explain your company's qualification and validation strategies
• Understand how to archive raw data from hybrid systems: electronic vs. paper
• Be able to define and demonstrate Part 11 compliance functionality to auditors and inspectors
• Be able to develop inspection ready documentation during on-going routine operation
• Learn how to avoid and/or respond to FDA inspectional observations and warning letters

Who will benefit:

IT/IS managers and System Administrators

QA Managers and Personnel

Laboratory Managers and Supervisors

Analysts

Validation Specialists

Software Developers

Regulatory Affairs

Training Departments

Documentation Departments

Consultants

Companies and Departments:

Pharmaceutical development and Quality control laboratories

Quality control laboratories of API manufacturers

Contract laboratories

Clinical Research Organization

Suppliers of analytical instruments and laboratory computer systems

Agenda:

Day 1 Schedule

Lecture 1:

Requirements and approaches for Analytical Instrument Qualification and Computer System Validation

FDA/EU, ICH and PIC/S requirements

Lessons from recent FDA Warning Letters and how to avoid them

Understanding the terminology: qualification, calibration, verification, validation.

USP Chapter <1058> for analytical instruments: current and proposed changes

Lessons from GAMP®5 and from the GAMP® guide: "A Risk based Approach to Laboratory Computerized Systems"

Selecting the right validation approach for commercial off-the-shelf systems

Planning for cost-effective qualification and validation

Which instruments require qualification/validation

Lecture 2:

Going through the equipment qualification phases

The instrument qualification lifecycle

Writing requirement specifications

Documenting installation and installation qualification

Testing for initial operational qualification

Leveraging system suitability testing for on-going performance qualification

Preparing inspection ready documentation

Preparing and executing test protocols

Documenting evidence of testing and handling deviations

Lecture 3:

Dealing with specific USP <1058> requirements

Qualification of firmware

Unplanned and routine maintenance

Change control

Time and event based requalification: the importance of risk assessment

Definition and handling of like-for-like changes

Allocating laboratory equipment in one of three USP categories A, B or C

Type and extent of qualification each category

Lecture 4:

Cost Effective Validation of Laboratory Computer Systems: Step-by-Step

Writing a validation project plan

Going through a complete laboratory computer system validation from beginning to end

Setting specifications, vendor assessment, IQ, OQ, PQ, and writing the validation report

How risk assessments can help to determine the type and detail of validation

Integrating the GAMP® guide with USP <1058> for integrated instrument and system validation

Validation of existing systems

Preparing inspection ready validation documentation

Special considerations for IT infrastructure qualification and validation of networked systems

Day 2 Schedule:

Lecture 1:

Maintaining the validated State of computer systems

System maintenance

Change control: Handling planned and unplanned changes

How to deal with security patches

Periodic review vs. revalidation of chromatographic data systems

The approach and practice of periodic review

Using periodic review to reduce frequency of revalidation

Criteria for time based revalidation

Lecture 2:

Validation and Use of Excel Spreadsheet applications

Designing spreadsheets for compliance

Validation approach for spreadsheet applications

When, what and how much to test?

Recommendations from GAMP®5 for testing native Excel functions

How to ensure spreadsheet and data integrity

Going through examples

Excel spreadsheet validation from beginning to the end: A case study that can be used by everybody

Lecture 3:

Introduction to FDA 21 CFR Part 11 and EU/PICS Annex 11

Objective, scope, current situation and future of Part11

Requirements overview and spirit of the regulation

Requirements for electronic records

Requirements for electronic and digital signature

Additional requirements from the PICS/EU Annex 11 and from the UK MHRA GMP Data Integrity Guideline.

FDA/EU inspection and enforcement practices of electronic records: examples of recent FDA warning letters and EU inspection reports

Define user requirements for Part11/Annex 11 based on risk

Upgrading old or purchasing new systems: compliance and business aspects

Six steps for risk based implementation of Part 11/Annex 11

Lecture 4:

Ensuring and documenting Integrity of Laboratory (Raw) data and other Records

Definition of raw data: FDA/EMA requirements

Defining and documenting 'complete records'

What to archive for hybrid systems: paper records or electronic records

The importance of electronic audit trail to document data integrity

Review of electronic audit trail: who, what, when and how

How to ensure availability of electronic records throughout the entire retention period

The importance of validating security and integrity functions

Examples how to ensure and document data integrity and security

Auditing laboratories for Part 11, Annex 11 and for the new UK MHRA GMP Data Integrity Guideline

Contact Information:

NetZealous LLC,

DBA GlobalCompliancePanel

161 Mission Falls Lane,

Suite 216, Fremont, CA 94539, USA         

USA Phone: 800-447-9407

Fax: 302-288-6884

support@globalcompliancepanel.com

http://www.globalcompliancepanel.com