PLEASE book by 6th JUNE 2016

MEDICAL DEVICE QMS & REGULATORY COURSE

Assuring your company’s regulatory compliance for imminent South African regulations …  27th JUNE to 1st JULY2016 (JHB) .. Capetonians and Durbanites please email info@r-sctraining.co.za if interested in a course in YOUR AREA

With the pending DOH Medical Device & IVD Regulations and guidelines this COURSE will let you know and understand the requirements and approach of medical device regulations, a quality management system and ISO13485 User, Patient and Product safety risk assessment, Documentation with Procedures and Records controls and internal auditing of a quality management system

Day 1: Introduction to ISO 13485 management system

What is a medical device, Quality Management system Process, Corrective and Preventive Action?

Product Safety, Role Players and Legislation, Regulations, classification, Essential Principles, Safety & Performance, Clinical Evaluation

DAY 2; ISO14971 Risk Management system; Risk analysis, Risk evaluation & Risk control, Risk management report, Post-production information

Day 3-4; ISO 13485 Management System review

Organization, Management System, Management Review, Document & Record Control, Contracts & Services, Complaints, non-conformance handling, Data Analysis, Continual Improvement, CAPA & Continual improvement

Day 4-5 Internal Auditing concepts and practical coverage of the auditing process for the planning, preparation, practice, reporting and follow up

Who Should Attend?

Quality and regulatory professionals, engineers, designers and managers, that have ISO9001 understanding and/or training, that need to know and understand the requirements for ISO 13485 quality systems, regulatory requirements and ISO 14971 Risk Management

Venue: Johannesburg (Shimadzu offices, Honeydew)

Price: full 5 days R10950.00 (5% Discount if PAID BY 6th JUNE 2016)

All prices exclude VAT @ 14%, Travel & Accommodation. payment required 2 weeks prior

Go to …. www.r-sctraining.co.za

OR CONTACT info@r-sctraining.co.za

This COURSE will enable knowledge and understanding about the requirements and approach of food safety regulations, a quality management system and ISO22000 requirements and food safety risk assessment using HACCP, Documents, Procedures and Records requirements and controls

Day 1: Introduction to FOOD SAFETY

• Overview of Food safety & Regulations 962 & 908
• Introduction to Risk / Hazard management Process & Control
• SANS 10330, ISO9001 & ISO22000

• Overview HACCP study – 7 principles

DAY 2; Documentation & Overview of Prerequisite programmes

• Planning and realisation of SAFE products
• Food Standards Programme Codex Alimentarius Commission’s general requirements
• Types of Food Hazards

• SANS 10049 & PAS 220

DAY 3 Overview if ISO22000

Organization, Management System, Management Review, Document & Record Control, Contracts & Services, Complaints, non-conformance handling, Data Analysis, Continual Improvement, CAPA & Continual improvement

Day 4-5 Document Control & Internal Auditing concepts and practical coverage of the auditing process for the planning, preparation, practice, reporting and follow up

Who Should Attend?

Quality and regulatory professions, food technologists, and management that need to understand and know the ISO22000 standard and requirements for internal auditing of ISO22000 quality systems

Venue: Johannesburg  (Shimadzu offices, Honeydew)

Price: full 5 days R10125, first 2 days R3975, last 3 days R6150; per person

All prices exclude VAT @ 14%, Travel & Accommodation

Full payment required 2 weeks prior  to date of training.

.

Go to …. www.r-sctraining.co.za

OR CONTACT info@r-sctraining.co.za 

RUDOLPH-SHORTT CONSULTANCY CC has launched a training division R-SCTRAINING in February 2014 – WHAT THIS SPACE !!