Industry Expert Learning Series HRDF SBL Claimable
Introduction to Medical Device Manufacturing Process Validation
DURATION : One (1) full day INTRODUCTION US FDA defines process validation as “establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality characteristics.” Class discussions also covers the harmonized interpretation of process validation and as required by US FDA’s Quality System Regulations (21 CFR 820) and under ISO 13485:2003.
Participants will be led by an accomplished tutor with over 2 decades of practical experience in the subject matter gained from auditing, training and quality assurance as well as management system development activities. Participants will engage in small group activities and lively debate, along with instructor led segments to gain the expertise needed to effectively manage process validation. The course is designed to ensure participants appreciate requirements for process validation.
Understand the role of equipment and process validation
Write validation records
Determine which processes to validate
Compare validation vs. qualification
Know when to revalidate
Validation Team members
Quality Assurance practitioners
Quality Control practitioners
Internal QMS Auditors
Regulatory Affairs personnel
PRE-REQUISITE This is an introductory course designed for individuals with little or no previous knowledge of Process Validation. Basic knowledge of medical devices, ISO 9001:2000/2008, or ISO 13485:2003 / 21 CFR 820 would be beneficial.
iNTERESTED TO FIND OUT MORE? For enquiries, please email to firstname.lastname@example.org. Medsociate Sdn Bhd (HRDF Approved Training Provider - Registration No. 4195) (AMMI Authorised Training Provider and Secretariat) Tel: +6010 4040 662 Fax: +603 2178 4347