Consulting Experience

Norwegian Chemical Supplier No. 1 1995 and Norwegian Chemical Supplier No. 2 1996

• Total quality management system: Written all parts of the TQM comprising quality manual and SOPs, covering all aspects of quality of products and service, and legal requirements from the Working Environments Act.

Royal Pharmaceutical Society of Great Britain 1995, 1996, and 1997

• Teaching team "Practical Computer Validation".

Swedish Pharmaceutical Company No. 1 1995

• LIMS: Written User Requirements Specification (URS) for a new LIMS.

Swedish Pharmaceutical Company No. 2 1995-98

• Computer Systems Validation Handbook: Reviewed and suggested corrections.

• LIMS: Vendor audit, co-project leader for implementation, responsible for SOPs and validation.

• Clinical system 1: Vendor audit, SOPs, validation.

• Clinical system 2: Retrospective validation. Vendor audit.

• Chromatography system: Prospective and retrospective validation. Vendor audit.

• 1 day seminar: Quality assuring the IT systems according to GMP and GLP.

• Internal audits of several types of IT systems’ validation protocols, validation documentation and reports.

Swedish Pharmaceutical Company No. 3 1995-96

• Chromatography system: System validation and SOPs, 3 Vendor audits.

Swedish Medical Device Company No. 1 1996-99

• 2 x 1 day seminar: Quality assuring the lab computer, and what standards to apply in this industry

• 2 short seminars: What is LIMS, and Quality Assurance for an IT department

• LIMS: 2 Vendor audits, implementation, validation, SOPs

Swedish Pharmaceutical Company No. 4 1997-98

• LIMS: Implementation, validation, SOPs

Swedish Pharmaceutical Company No. 5 1997-98

• LIMS: Assessment of vendor replies to URS, vendor audit, validation and SOPs

• 2 day seminar: Validation of LIMS in the pharmaceutical industry

Norwegian Pharmaceutical Raw Material Company No. 1 1997-98 and 2000 – 2001

• Seminar: Validation of computer systems

• SAP: Vendor audit

• LIMS: URS, in-house test plan, vendor audits

Danish Pharmaceutical Company No. 1 1998 - 2003

• LIMS Project team member with 50% time for nearly 2 years: URS, in-house test plans, quality/validation plan, vendor selection, SOPs, system validation, implementation & qualification of static data in system.

• 3 Seminars: 21 CFR Part 11 & Validation of LIMS, tailored to the company’s internal requirements and the chosen LIMS

• Toxicology LIMS: URS, assessing vendor answers to URS, quality/validation plan

• Drug analysis LIMS: Assessing documentation

• 21 CFR Part 11 project: Checklists, class, assessment of app. 30 systems with action suggestions

• Batch documentation management system: Validation plan

Norwegian Governmental Agency No. 1 1998-1999

• Seminar: Validation of LIMS in the EN 45001 accredited environment

• LIMS: implementation, validation, Standard operating procedures (SOP)

Norwegian Accreditation 1998

• Seminar: Year 2000 problem in the accredited laboratory

Norwegian Pharmaceutical Company No. 1 1999-2001

• LIMS: Feasibility study

• MRP: URS, Vendor audit

Norwegian Pharmaceutical Company No. 2 2000

• Seminar: LIMS project and system validation

• LIMS: Quality / Validation plan

Swedish Medical Device Company No. 2 2000 - 2002

• Seminar: LIMS project and system validation

• LIMS: URS, assessment of vendor answers, vendor audit, leading the validation process

• Class: LIMS validation, 21 CFR 11 and GMP requirements

Norwegian Pharmaceutical Company No. 3 2001

• Short seminar: 21 CFR Part 11

• Class for 100 employees: 21 CFR Part 11

• Workshop: LIMS validation, status and plans

• Workshop: Computer systems validation according to 21 CFR Part 11

Finnish LIMS Vendor No. 1 2002

• Seminar for their user group: Validation of LIMS, requirements according to various standards

• Review of their LIMS system and service: Assessment according to 21 CFR Part 11, GMP and ISO 17025

• 2 Seminars for their user groups 2002: Electronic signatures and electronic records

Open Classes Norway 2001

• 21 CFR Part 11: Interpretation of the regulations, and practical implementation

• Validation of IT system: Which activities are included, and how to handle them

Open Classes Finland 2001

• 21 CFR Part 11: Interpretation of the regulations, and practical implementation

• Validation of IT system: Which activities are included, and how to handle them

Swiss Pharmaceutical Company No. 1 2001

• Chromatography system: Vendor audit

• LIMS system: Vendor audit

• MRP system: Vendor audit

Norwegian Pharmaceutical Company No. 4 2001

• Documentation system: Vendor audit

Norwegian Medical Device Company No. 1 2001

• Medical device: OQ/PQ plan, testing and report

Norwegian Pharmaceutical Company No. 5 2001

• MRP system: Vendor audit

Norwegian Pharmaceutical Company No. 6 2001 - 2003

• QA system top level: SOPs for IT systems

• Acting as QA manager for IT systems for 1 month
• Document Management system: SOPs and 21CFR11 status and test plans

Norwegian Computer Systems vendor No. 1 2001

• Seminar: Build in quality according to 21 CFR Part 11 and ISO 9000-3

Norwegian Pharmaceutical Company No. 7 2001

• Internal audit of IT systems used for API production