Course Catalog

Introduction to Pharmaceutical Analysis

Pharmaceutical Analysis determines the quality of drug products via analytical chemistry.  This course will introduce areas such as method validation, handling raw materials and finished products, documentations, inspections that impact the development of pharmaceutical products. Throughout this course, critical cGMPs regulations, FDA guidances and ICH Quality guidelines will be discussed specifically emphasizing procedures to help individuals to maintain a high level of compliance that rounds the laboratory environment.  It also reviews several quality systems that support the analytical.

Course Details

Key Topics

  • Laboratory Controls and Regulations
  • Good Documentation Practices
  • Overview of Common Analytical Methods
  • Method Validation and Transfer
  • Out-of-Specs Investigations
  • Quality Systems and Pharmaceutical Industry

Information

Pharmaceutical Analysis determines the quality of drug products via analytical chemistry.  This course will introduce areas such as method validation, handling raw materials and finished products, documentations, inspections that impact the development of pharmaceutical products. Throughout this course, critical cGMPs regulations, FDA guidances and ICH Quality guidelines will be discussed specifically emphasizing procedures to help individuals to maintain a high level of compliance that rounds the laboratory environment.  It also reviews several quality systems that support the analytical.

Who Should Attend

This two-day course will benefit scientists, regulators, and researchers, who perform analytical testing or manage an analytical laboratory for pharmaceutical analyses.  It will introduce individuals to the analytical development areas and the regulations that affect quality systems and laboratory functions. It is intended for manufacturers of OTC, generics and new drug products as well as contract research organizations (CROs), government labs since the pharmaceutical products have similar regulatory requirements.  It is an excellent course for those who wish to gain more information to the pharmaceutical industry.

Benefits

  • Understand the roles of pharmaceutical analysis
  • Discuss the element of analytical chemistry in the drug development process
  • Learn about FDA and ICH regulatory guidance and its impact on the pharmaceutical labs
  • Discuss Good Documentation Practices
  • Understand Out-of-Specs (OOS) and how to conduct OOS investigation.
  • Understand validation requirements for analytical procedures
  • Explore how to handle impurities and degradation products
  • Discuss current compliance and technical issues with field expert
  • Review key factors for analytical records and reports

Agenda

  • Laboratory Controls and Regulations
    • FDA roles and laboratory regulations
    • ICH and their quality guidelines
    • Pharmacopeia and its impact
    • Drug Development Process and Good Manufacturing Practices
  • Good Documentation Practices
    • Raw Data documentation
    • Notebook entry and lab results
    • Calculation and reporting analytical data
    • Protocol and acceptance criteria
    • Amendments and Deviations
    • Change control system.
  • Overview of Common Analytical Methods
    • Separation Methods
    • Spectroscopic Methods
    • Wet Chemistry method
    • Performance Tests
    • Basic laboratory equipment and Measurements
    • Solutions and dilutions
    • Calibration standards
  • Method Validation and Transfer
    • Typical Validation characteristics
    • Type of Analytical Procedures
    • System Suitability
    • Stability Indicating Methods
    • Validation Life Cycle
    • Strategies to transfer methods
  • Out-of-Specs Investigations
    • Define Out of Specification
    • Lab scale investigation
    • Full Scale investigation
    • Documentation of investigation.
  • Quality Systems and Pharmaceutical Industry
    • Stability Program
    • Training Program
    • Metrology Program
    • Audit and Inspection of the labs

Course Locations

Date

TBA

Check-in opens at 7:30 a.m. on the first day of the course.

Course runs from 8:30 a.m. to 5:00 p.m. each day.

Register Via Mail

Venue

Location - TBA

The course fee includes a course binder and a continental breakfast each day.

Five for Four! Register five people for one course, one person for five courses, or any combination in between and your fifth registration is free. Note: This discount is only available if you register by fax or mail and mention this discount. May not be combined with any other offer.


Pricing
  Member Non-Member
Advanced $1,695 $1,895
Standard $1,895 $2,095

About the Instructor

  • Kim Huynh-Ba

    has almost 28 years of experience in GMPs, analytical development and stability sciences in Pharmaceutical Industry.