Training
We are the first Arab and Egyptian consulting office having accredited by ISO 21001:2018 for its quality management system for provision of training courses according to the standards of international educational institutions, which enables it to provide international training / training services in the pharmaceutical industries, personal care products, nutritional supplements, as well as medical requirements in the areas of: registration processes And manufacturing, quality assurance, drug alertness, and drug economics.
As public health and safety standards evolve around the world, companies must make sure their employees receive essential education and training to stay ahead of the curve. NSF International understands the challenges businesses face, and provides timely and pertinent training and instruction at all levels, from plant floor to senior executives. We provide several training courses as:
Dietary Supplements Training
Personal hygiene training
HACCP awareness
HACCP implementation
HACCP internal audit
ISO 22000 awareness
ISO 22000 implementation
Food safety management system level 2,3 and 4
HALAL certification training course
FSSC training course
Food additives approval training course
Shelf life for food categories training course
Compliance international food labeling training course
International compliance labeling dietary supplements training course
Outbreak food born illness investigation training course
Layout design and approval for all food premises activity
Health and safety training course
Pesticide and veterinary drugs residual training course
ISO 9001 management Systems Registration Training
ISO 17020 training course
ISO 17025 training course
Medical Devices Training
our customized courses cover topics such as:
⦁ ISO 13485 training for medical device quality management system (QMS) requirements
⦁ New EU Medical Device Regulations training
⦁ CQI/IRCA ISO 13485 Lead Auditor training for medical devices
⦁ Medical Device Single Audit Program (MDSAP) training
Pharmaceutical Training
Our customized training courses include:
Auditor Training
G⦁ M⦁ P Training
Qualified Person Training
Quality Systems Training
Technical Training
Webinars
Water and Wastewater Training
Registration of Drug and Dossier Preparation (CTD and eCTD Submission)
This course takes through the essential steps for submitting manual/electronic submission to the Local /international regulatory agencies. The CTD/eCTD format has become mandatory in key markets for electronic submissions. This course provides a quick overview of current regulatory guidelines of CTD/eCTD in major world market including North America, the European Union etc. It aims to introduce tools to assist the participants in formulating effective strategies in the development, compilation, and submission of US/EMA compliant CTD/eCTD. It concludes the following modules:
Module 1 : Market authorization & electronic submission in major markets
Module 2 : Registration of Drug and Dossier Preparation (CTD and e CTD submission)
Module 3 : Drug Registration, CTD and e CTD submission.
Module 4 : Industry specific case studies
Pharmacovigilance: Regulatory and procedural guidance
Good pharmacovigilance practices
Training on Pharmacovigilance Activities in EU
Post Market Surveillance and Adverse Event Reporting
CE Marking 93/42/EEC and the new MDR
Creating a Technical File / Design Dossier
Risk Management – EN ISO 14971
Microbiology for Compliance Teams
Cleanroom Good Manufacturing Practice (GMP)