Description

ICTE
International College of Technical Education Pvt. Ltd
Head Office :
Office # 27, Second Floor, Maryam Shadi Hall Plaza
(Airies Plaza), Shamsabad, Murree Road,
Rawalpindi, Pakistan 46000.
Email : info@icollegete.com
Contact : 051-6122937, 0311-5193625, 0092-335-4176949
The Certificate program in Quality Assurance and/or Compliance focuses on biologics, drugs, and their quality requirements. It teaches the differences between quality assurance and control and how they interact with manufacturing. The program emphasizes the importance of establishing a quality system during the early stages of drug development. It also discusses FDA regulations and how Quality Assurance monitors compliance with these rules. The program is designed for those who are pursuing a career in the pharmaceutical industry or are in their final year of a bachelor’s degree program.This certificate focuses on preparing students for entry-level positions in the quality assurance industry. It covers the principles of mechanical and systems quality assurance and introduces them to the use of inspection tools and blueprints. Graduates may choose to apply the credits they earn in this program toward a degree in Manufacturing Industrial Engineering Technology. In addition, it enables students to work towards a certified quality technician certification through the American Society for Quality.The course will explain the natures of, and differences between, Quality Assurance & Quality Control. Quality Assurance is process oriented and focuses on defect prevention, whilst Quality Control is product or service oriented and focuses on defect identification and remedy. Typically, Quality Assurance involves extensive planning of activities to prevent things going wrong and leading to poor product or service. In contrast, Quality Control techniques exist to to maintain standards in operations and achieve Improvement.
Course Outline
The Differences between Quality Assurance & Quality Control
Quality Assurance as Process Oriented focused on Defect Prevention
Quality Control as Product Oriented and focused on Defect Identification
Use of Quality Control Techniques to Maintain Standards and Achieve Improvement
The Simple Management Activities Key to QA & enhanced Business Performance
NCR’s and Corrective Action
QA and QC Tools and Templates
International Best Practices
The Links between Improved Product Quality, enhanced Customer Satisfaction & Repeat Business
The Links between Superior Management Control of Key Activities, Waste Reduction & Improved Profitability.
Foundation in Quality Management
History & Evolution of Quality Control, Quality Assurance & Quality Management
Quality Management System Models & Standards
Challenges in Implementation of Quality Management
Quality Management Principles
Cost of Poor Quality
People in Quality
Seven Basic tools of Statistical Quality Control (SQC)
Introduction to Lean Six Sigma
Introduction to Kaizen
ISO 9001:2015 QMS Standard
Auditing Quality Management System