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45 - PHR - Pharmaceutical Sciences

PHR 103 - Good Manufacturing Practice (GMP) Guidelines

Code Start Date Duration Venue
PHR 103 25 March 2024 5 Days Istanbul Registration Form Link
PHR 103 29 April 2024 5 Days Istanbul Registration Form Link
PHR 103 03 June 2024 5 Days Istanbul Registration Form Link
PHR 103 08 July 2024 5 Days Istanbul Registration Form Link
PHR 103 12 August 2024 5 Days Istanbul Registration Form Link
PHR 103 16 September 2024 5 Days Istanbul Registration Form Link
PHR 103 21 October 2024 5 Days Istanbul Registration Form Link
PHR 103 25 November 2024 5 Days Istanbul Registration Form Link
PHR 103 30 December 2024 5 Days Istanbul Registration Form Link
Please contact us for fees


Course Description

Good Manufacturing Practice regulations (cGMPs) apply to pharmaceutical, biotechnology and medical device products regulated by FDA.  This course explores the content and interpretation of the regulations, with emphasis on the necessary practices, procedures and documentation required to achieve full compliance.

The course will utilize case studies to facilitate interpretation and application of regulations. The attendees will gain understanding of how knowledge of the regulations facilitates efficient and cost effective issue resolution.

Course Objectives

  • Gaining a fundamental knowledge of the basis of cGMP regulations,
  • Knowing about cGMP regulations and their application to laboratory activities, manufacturing processes and support functions,
  • Demonstrating the need for thorough and comprehensive GMP training and documentation,
  • Understanding the common terminology and the role GMPs play in their day-to-day responsibilities,
  • Managing the implementation of GMP efforts and proactively sustaining a culture of compliance in all scientific and manufacturing efforts,
  • Examining consequences of non-compliance.

Who Should Attend?

  • Pharmaceutical industry employees
  • Technical Assistants
  • Laboratory Assistants
  • Quality Control Managers 
  • Quality Assurance Managers
  • Management interested in effective GMP compliance tools and techniques.

Course Details/Schedule

Day 1

  •  Food Drug and Cosmetic Act
  • The Federal Food, Drug, and Cosmetic Act of 1938 and historic milestones
  • Subsequent acts, amendments and final rules
  • The Food, Drug and Cosmetic Act and the Code of Federal Regulations: Interpretation and Compliance
  • Review of landmark cases
  • FDA Enforcement Strategies
  • Establishment Inspection Reports, FDA-483's and Advisory actions
  • Judicial actions
  • Current Enforcement strategy trends
  • Managing FDA regulatory actions

Day 2

  • The Food and Drug Administration (FDA)
  • Navigating the FDA website
  • Investigations operations manual and compliance policy guides
  • Overview of current initiatives in CDRH and CDER
  • FDA Inspections
  • GMP inspections
  • Pre-approval inspections
  • Other and "For cause" inspections
  • The International Council on Harmonization (ICH)
  • Purpose of organization
  • Legal status of USP
  • ICH Working Groups
  • Quality Guidelines

Day 3

  • Regulations
  • Drug, biotech and device regulations
  • Guidance documents
  • Best practices in achieving compliance
  • Overview of quality systems
  • Quality systems approach to GMP compliance for drugs and devices
  • Overview of key quality systems
  • Flexibility of the GMP for medical devices
  • GMP applications and exemptions
  • Establishing robust processes to maintain compliance throughout product lifecycle

Day 4

  • Quality control unit responsibilities
  • Purpose of the quality control unit
  • Division of responsibilities
  • Monitoring, assessing and implementing an effective quality control unit
  • Sustainable GMP compliance
  • Effective internal auditing and mock inspections to monitor compliance
  • Concept of 'Life Cycle Validation' including monitoring program
  • Establishing predictive metrics: what to measure and why
  • Managing change – adding new products and retiring old products
  • Managing deviations, exceptions, and Corrective & Preventative Actions (CAPAs)
  • Implementing preventive solutions
  • Escalation and response

Day 5

  • Drug and device case studies
  • Executing investigations for both drugs and devices
  • Warning letter response
  • Consent Decree remediation
  • Challenges to the current FDA enforcement model
  • Drug shortage crisis
  • FDA's Global Engagement Strategy
  • Supply chain integrity