Reflector Consulting

Trainings

Organized training

When you want to take part in an organized training, please fill in the contact form (under contact) and please add comment (name, address, e-mail and training you want to be part of)

Training on request

Customized trainings on Toxicological or Quality aspects can be requested.

Below you can find some examples of training programs on toxicology and quality. You can use the filter buttons below.

Background – Human toxicology

Contents: Guidelines & Principles, (sub)acute & (sub)chronic toxicity, local tolerance, genetic toxicity, reproductive toxicity and carcinogenicity.

Short training (1- 1.5 h)

Toxicological risk assessment on Impurities, Extractables & Leachables in Medicines

Contents: ICH Guidelines & PQRI recommendations, major toxicological endpoints & thresholds, hazard evaluation methods, Case studies & examples.

Short training (1- 1.5 h)

Toxicological risk assessment on Extractables & Leachables for Medical Devices

Contents: Introduction on ISO 10993-18/17/1, major toxicological endpoints & thresholds, hazard evaluation methods, limits according to ISO 10993-17, focus on requirements of the Medical Device Regulation.

Short training (1- 1.5 h)

GLP Introduction

Contents: history – guidelines – definitions – 10 main principles.

Short training (1- 1.5 h)

GLP Inspections

Contents: Inspection by Belgian GLP monitoring Authority (pre-inspection, facility/study inspection, follow-up inspections); Internal QA (quality assurance) inspections (facility, study, process).

Short training (1- 1.5 h)

GLP study conduct

Contents: responsibility (test facility management, study director, QA, archivist); documents (standard operating procedures, study plan & amendments, study report, study deviations…).

Short training (2.5- 3 h)

GLP installation planning

Contents: Discussion on and planning of (incl. timelines) the organization, personnel, facilities, test & reference item, test systems, standard operating procedures.

Short training (2.5- 3 h)

In vivo toxicology studies

Scientific principles and guidelines, Subacute, Subchronic and Chronic toxicity, Reproductive and Developmental toxicity, Skin sensitisation and Carcinogenicity, Case studies and exercises.

Workshop (1 day)

In vitro toxicology studies

Genetic toxicity, Alternative methods, Eye and skin irritation, Skin sensitisation, Case studies and exercises.

Workshop (1 day)

In silico toxicology

(Q)SAR models, Creation of QMRF and QPRF reports, Case studies mutagenicity and skin sensitisation, Reliability of QSARs, Tips & tricks.

Workshop (1 day)

Threshold of Toxicological Concern

Short TTC history, TTC Endpoints & background data, Mutagenicity/Genotoxicity/Carcinogenicity TTC , Examples of application in food & FCM, Tips & tricks.

Workshop (0.5 day)

Basic GLP training

* GLP Principles (Guidelines, definitions & principles, with examples and exercises)
* GLP Documentation (GLP certificate, GLP statement, QA statement, Raw data, …)
* Introduction to Electronic Raw Data (Definitions, systems, responsibilities, …)

Workshop (0.5 day)

Multisite study monitoring training

* 2(A) Preclinical CRO Selection (GLP compliance, documentation, …)
* 2(B) Multisite Regulations (Definitions, responsibilities, documentation …)
* 2(C) Study Monitoring (Attention points, Documentation …)

Workshop (0.5 day)

Cleaning Validation

& calculation of Permitted Daily Exposure PDE or Health Based Exposure Level (HBEL)

Training on request

REACH toxicological endpoints

& calculation of Derived No or Minimum Effect Levels (DNEL/DMEL)

Training on request

Read-across approaches

& justification in toxicological safety evaluation

Training on request

Instrumentation

maintenance, control, calibration & validation

Training on request

Analytical method validation

principles & examples

Training on request

Computer Systems Validation

& Data integrity principles

Training on request