Introduction to Pharmaceutical Quality

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Duration :

10

hour(s)

Skill level:

Regulatory

Language:

English

Final exam:

Yes

Certificate of Completion:

Yes

CEU / CPD Accreditation:

Yes

Certification:

Gain a recognized and traceable certificate after completing the course : 

All our certificates are unique, authentic, CPD/CEU accredited, and FDA 21 CFR PART 11 compliant. Certificates validity can be checked online through our certificate online checker.

Description:

The idea that final testing of pharmaceutical products does anything with regards to ensuring quality has long been exposed as a lie. Quality has been defined in numerous ways, however, a definition that captures adequately what it means in the pharmaceutical industry is the fitness for use. This goal can only be achieved by building quality into the end product through every process in its actualization. This goes as far back as sourcing for good quality raw materials, subjecting systems and equipment to routine evaluations, and improving the manufacturing process while taking into consideration feedback from these evaluations and final consumers. This course introduces students to the concepts of the Quality Management System and Total Quality Management. You will also be introduced to the role of ICH guidelines in achieving quality the process way.

 

In this course, we provide a synthesis of the topic through an interactive online experience. This material was built by a team of Regulatory Affairs Experts with a Qualification from Northeastern University, Boston, piloted by a Senior Member able to articulate theory with practice.

 

 

Curriculum

 

Landing Page

 

Lesson 1: Pharmaceutical Quality

 

  • The Concept of Quality
  • What is Quality Control (QC)?
  • What is in-Process Quality Control (IPQC)?
  • What is Quality Assurance?
  • Comparison of QA and QC

 

Lesson 2: Quality Management System (QMS)

 

  • Objective of Quality Management
  • Quality Management System
  • Application of Quality Management System to cGMP
  • Part A: Management Responsibilities
  • Part B: Resource
  • Part C: Manufacturing Operations
  • Part D: Evaluation Activities

 

Lesson 3: Total Quality Management (TQM)

 

  • Common Mistakes and Barriers in the Implementation of TQM
  • 6Cs for Implementation of TQM
  • TQM Methods and Tools

 

Lesson 4: Quality Manual and Quality Policy

 

  • The Purpose of Quality Manual
  • Structure and Format of the Quality Manual
  • Quality Policy

 

Lesson 5: Understanding Pharmaceutical Quality by Design

 

  • What is Quality by Testing?
  • What is Quality by Design (QbD)?
  • Objectives of Pharmaceutical Quality by Design
  • Elements of QbD
  • Quality Target Product (QTPP) That Identifies the Critical Quality Attributes (CQA) of the Drug Product
  • Product Design and Understanding
  • Process Design and Understanding
  • Control Strategy
  • Process Capability and Continual Improvement
  • Four Tools of QbD
  • Tool 1: Prior Knowledge
  • Tool 2: Risk Assessment
  • Tool 3: Mechanistic Model, Design of Experiments (DoE), and Data Analysis
  • Tool 4: Process Analytical Technology

 

Lesson 6: ICH Guidelines

 

  • Introduction
  • List of ICH Guidelines

 

Glossary

 

Quiz

 

Author:

swati
Swati Pund
Swati Pund holds a Doctorate in Pharmaceutical Sciences with post-doctoral research experience in nanomedicine at IIT-Bombay, India. She has more than 20 years of experience in the academic, pharma industry, and pharmaceutical research laboratories. Her expertise includes Conventional and nano-delivery systems of drugs and nutraceuticals, Targeted drug delivery systems, Optimization of formulation and process using QbD, Biopharmaceutics and pharmacokinetic analysis, Mammalian cell culture techniques, and Animal model development Swati is a Co-Founder of Biobay (www.biobaysolutions.com), and her main activity is Pharmaceutical Consultancy and Scientific Communications.

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