The course is designed for students and industry professionals who have little or no knowledge in Quality Control . This course will help them understand the fundamental and concepts of Quality Control and Assurance. It will enhance their knowledge and skills in the field of QA QC. AS a Quality control/ Quality assurance officer you will work in Quality department of a pharmaceutical company. The main aim of the department revolves around controlling quality and assuring the best possible product.
Course Objective
- To create a thorough understanding of important QC QA.
- To create experts in the field of Quality control & Quality Assurance.
- To encourage continuous learning and development in QC QA.
- To clear the basic fundamentals of Quality concepts.
- To update knowledge of existing QC QA professionals.
Course Structure
- Introduction to QC/QA
- Introduction to Instrumentation required for QC/QA
- Introduction to Quality Standards
- Excipients, Active Pharmaceutical Ingredients, Dosage forms, Packaging Material
- Quality Documentation and Review Procedure
- COPP Scheme for Pharmaceutical Products
- Good Manufacturing / Laboratory Practices and Audit
- QC / QA Functions / In process QC/QA functions
- Regulatory Aspects of QC/QA
Course Methodology
- This is a Distance learning Program – where students participate by filling necessary forms and paying the fees.
- Introduction Kit is delivered to participants of the program – this kit will contain study material and all necessary information about the program with important dates
- The Participant is required to complete a Project on an allocated topic during the term of the program, these reports have to be submitted by prescribed dates.
- The Participant will be able to interact with other program participant through the use of online blog. Each participant will be given a unique User ID and password for the same.
- Participants will be evaluated based on project submitted & final examination held at the end of the term.
- The participant will be able to share their views and ask question in the blog openly, this blog will be monitored by RA experts to answer any queries or doubts apart from that timely news and development will also be updated over there.
Learning outcome
- Understand Pharmaceutical Quality related Concepts
- Able to write and review Quality Documents like SOPS,BMR etc
- In process Quality Control
- Establish QC/QA Labs
- Preparation for audits and inspections
- Manufacturing Control
- Chemical and physical analysis
- Instrumental analysis(GC, HPLC, UV, HPTLC, Dissolution)
- Standards (RS and WRS) · Good laboratory practices
- Application of microbiology in pharmaceutical testing
- Impurities (known and unknown) : ICH guideline
- Calibration of instruments
- Packing material analysis
- Deviations Planned and Unplanned
- Post release monitoring-complaints, recalls
Career Opportunities
A career in Quality Control/Quality Assurance is a highly challenging career. QC/QA department are the 2 backbones of any pharmaceutical company, the company cannot stand in domestic or international market without them. All regulatory agencies focus on Quality as a main issue in any facility and guidelines for the same are always updated.
The Pharma industry is growing at a rapid pace and there is a rising concern over quality of pharmaceutical and medical device products. With the increasing number of pharma companies the demand for QC /QA professionals is always on the rise.
- Type of companies hiring RA professionals
- Pharmaceutical
- Medical Devices
- In Vitro Diagnostics
- Biologics and Biotechnology
- Veterinary Products
- Cosmetics
- Clinical Research Organization/ Contract Research Organization
- Pharmaceutical consultancy companies
- QC/QA professional can get employment as
- Quality Control Analyst
- Quality Control officer
- Quality Control head/ Director
- Quality Assurance officer
- Quality Assurance head
- In Process Quality Control Officer
- In process Quality Assurance Officer
Eligibility
- Graduates in any stream of science are eligible to apply.