Contact Me
Cost for each online course: 400 SEK + VAT (20%) =
pdf of powerpoint with detailed explanation in note +
Selftest questionaire + Training Certificate
For Training online or F2F Training for a group of person:
please Contact Me below
ICH GCP (R2)
Basic or Refresher
Training Content:
•Module 1: What is and Why GCP-
-EU Directives and local swedish regulations
•Module 2: ICH GCP E6 Principles
•Module 3: Investigators Responsibilities
•Module 4: AEs/ SAEs
•Module 5: Confidentiality- Data Security
ICH GCP (R2)
Refresher for Sponsor
Training Content:
•Module 1: Quick Summary of ICH GCP
•Module 2: Sponsor Responsibilities- Site selection/CRO Selection- Practical Tips
•Module 3: Sponsor Oversight- Practical Tips
•Module 4: Essential documents-Practical Tips
•Module 5: Risk Assessment-Practical Tips
OECD GLP
Basic or Refresher
Training Content:
•Module 1: History of GLP
-OECD Framework
•Module 2: EU Regulatory framework and Swedish Regulatory
•Module 3: OECD GLP Principles
•Module 4: Findings in different GLP areas
GCLP BARQA
Training Content:
•Module 1: History of GCLP
•Module 2: GCLP BARQA Structure
•Module 3: Findings in different GCLP areas
ISO 14155:2020
Basic or For GCP Personnel
Training Content:
•Module 1: short intro of ISO14155 & MDR
•Module 2: summary of changes in ISO14155:2020
•Module 3: differences in terminology between ISO 14155 & ICH GCP
•Module 4: key relevant aspects of ISO 14155 for clinical personnel
ISO 20916:2019
Basic or For GCP Personnel
Training Content:
•Module 1: What is and Why ISO 20916
•Module 2: ISO 20916 Structures and Annexes
ISO 14155:2020
Basic For Statistician
Training Content:
Module 1: Background to ISO 14155
Module 2: Comparison between Medical Device Investigation VS Medicinal Trial
Module 3: What Changes in ISO 14155:2020
Module 4: Annex A: Statistical Analysis
Module 5: Key Sections of ISO 14155:2020
Trainings
To make training effective, online trainings ISO 14155, ISO 20916, ICH GCP, OECD GLP, GCLP were designed for specific roles. On Site (f2f or via Teams) trainings will give you more in-sight on daily challenges, study scenarios, hands-on tips tailored to specific tasks, based on my own auditing experiences.
Short ISO 14155: 2020 trainings for already GCP trained personnel.
Basic ISO 14155: 2020, GCP for MD Trial trainings for all.
Basic ISO 20916: 2019 , GCP for IVD Trial trainings for all
ICH GCP E6 (R2) courses meets minimum criteria for ICH GCP Investigator site personnel training by TransCelerate Biopharma as necessary to enable mutual recognition of GCP training among trial sponsors.
OECD GLP and GCLP are for bioanalytical laboratory personnel.
Training Certificate will be provided (You must get at least 80% score)
Coaching
A 3 month or 6 month coaching/mentor program is available for a junior QA who needs coaching or advice in performing different types of audits and for a senior QA who needs coaching in performing new types of audits.
.jpg)