Course Catalog

Critical cGMP and ICH Regulations for Pharmaceutical Laboratories

Analytical laboratories hold major functions in the pharmaceutical industry. Throughout this course, critical cGMPs regulations, FDA guidances and ICH Quality guidelines will be introduced 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 laboratory such as:

  • cGMP and ICH regulations
  • Pharmaceutical Quality Systems
  • Analytical Method Validation
  • Stability Program
  • Audit and Inspection

Course Details

Key Topics

  • Laboratory Control and the Drug Development Process
  • Method Validation
  • Stability Program and related topics
  • Analytical Records and Reports
  • Preparing for Quality Audits and Inspections

Information

Analytical laboratories hold major functions in the pharmaceutical industry. Throughout this course, critical cGMPs regulations, FDA guidances and ICH Quality guidelines will be introduced 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 laboratory such as:

  • cGMP and ICH regulations
  • Pharmaceutical Quality Systems
  • Analytical Method Validation
  • Stability Program
  • Audit and Inspection

Who Should Attend

This one-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 cGMP and ICH and FDA regulations that cover the quality systems, controls and operations of the 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 fundamentals of cGMP and it roles in drug development process
  • Learn about ICH regulatory guidance and its impact on the pharmaceutical labs
  • 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 Control and the Drug Development Process – cGMPs on laboratory controls, drug development, roles of analysts, pharmaceutical quality systems
  • Method Validation – types of analytical procedures, validation characteristics, specificity, stability indicating, accuracy, precision, DL/QL, robustness
  • Stability Program and related topics – role of stability program, US/ICH/WHO stability guidelines, global submission and protocol, how to maintain a compliant system for stability.
  • Analytical Records and Reports – key issues of data reporting, review of warning letters, practical systems to develop for data recording.
  • Preparing for Quality Audits and Inspections – purpose of audit/inspection, audit agenda, how to handle regulatory audits.

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 Online Register Via Mail

Venue

TBA


Pricing
  Member Non-Member
Advanced $795 $995
Standard $1,095 $1,295

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.

About the Instructor

  • Kim Huynh-Ba

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