4 Half-Day Live Virtual Training

Good Manufacturing Practices (cGMP) Training

A live, instructor-led virtual course designed to make GMP compliance practical, engaging, and easier to apply across pharma, biotech, and life sciences operations.

Format 4 Half-Day Virtual Training Online Live
Date July 27-30, 2026
Monday-Thursday
Time 12:00 PM - 03:00 PM ET
06:00 PM - 09:00 PM CET

Includes presentation materials, live Q&A, and certificate of participation.Attend Live or Book a Private Session in your timezone.

Purchase Options

Choose Your cGMP Training Registration

Select live virtual training or on-demand recorded access for the 4 half-day cGMP course.

$6,995

$3,995

Save $3,000

Live Group up to 2-5 Participants

On Demand Recorded Access Free

You get 2-5 log-ins for the live 4 half-day virtual seminar for all participants, presentation materials, certificate of completion, and the opportunity to ask questions by phone and email.

  • 2-5 participant log-ins
  • Live 4 half-day virtual seminar
  • On-demand recorded access included
  • Presentation materials included
  • Certificate of completion included
Register Group for $3,995
$2,095

$1,498

Save $597

Simulation Live - 1 Year Access

On Demand Recorded Access for 1 Year

You’ll have 12-month single-user access to an archived recording of the entire 4 half-day virtual seminar, including the Q&A period. You can log in any time of day or night.

  • 12-month single-user access
  • Archived recording included
  • Q&A period included
  • Presentation materials included
  • Audio recording and transcript included
  • Delivery approximately 48 hours after session
Buy On Demand for $1,498

All options include presentation materials. Live options include certificate of completion and the opportunity to ask questions by phone and email.

Course Agenda

4-Day GMP Training Agenda

Explore the daily modules covering GMP fundamentals, compliant operations, data integrity, inspection readiness, and quality excellence.

Day 1 - GMP Fundamentals & Regulatory Expectations

Build a strong foundation in cGMP requirements, regulatory expectations, global standards, personnel responsibilities, and quality culture.

Module 1: GMP Foundations

  • Introduction and course objectives
  • Current GMP challenges in 2026
  • Understanding cGMP requirements
  • Quality culture and compliance mindset
  • Risk-based thinking in GMP

Module 2: Regulatory Framework

  • FDA organization and mission
  • Food Drug & Cosmetic Act
  • 21 CFR regulations overview
  • Guidance documents and enforcement
  • FDA inspection program
  • FDA warning letters and enforcement trends

Module 3: Global GMP Landscape

  • EU GMP requirements
  • ICH guidelines
  • WHO GMP expectations
  • Harmonization of global regulations
  • International inspection trends

Module 4: Organization & Personnel

  • Quality management systems
  • Roles and responsibilities
  • Management responsibility
  • Training and qualification programs
  • Electronic records and electronic signatures
  • GMP metrics and KPI management

Module 5: Quality Culture Excellence

  • Building a sustainable quality culture
  • Human error prevention
  • Quality ownership
  • Leadership accountability
  • Continuous improvement framework

Day 2 - Building a Compliant GMP Operation

Focus on facilities, equipment, materials, supply chain controls, production systems, packaging, labeling, validation, and qualification.

Module 6: Facilities & Equipment

  • Facility design principles
  • Cleanroom concepts
  • Material, personnel and air flow
  • Utilities management
  • Equipment lifecycle management
  • Calibration and maintenance programs

Module 7: Materials & Supply Chain Controls

  • Supplier qualification
  • Supplier audits
  • Vendor risk management
  • Incoming material controls
  • Storage and distribution controls
  • Contract manufacturer oversight

Module 8: Production & Process Controls

  • Manufacturing controls
  • Master batch records
  • Batch documentation review
  • Change control systems
  • Deviations during manufacturing
  • Process monitoring

Module 9: Packaging & Labeling

  • Label control systems
  • Packaging operations
  • Reconciliation practices
  • Prevention of mix-ups
  • Serialization overview

Module 10: Validation & Qualification

  • Validation lifecycle
  • IQ/OQ/PQ
  • Validation master planning
  • Process validation
  • Continued process verification
  • Risk-based validation principles

Day 3 - Quality Systems, Data Integrity & Digital Compliance

Review laboratory controls, ALCOA+, data integrity, computer software assurance, AI governance, product release, and distribution compliance.

Module 11: Laboratory Controls

  • QC laboratory systems
  • Sampling plans
  • Analytical method validation
  • Reference standards
  • Laboratory documentation
  • Equipment qualification

Module 12: Data Integrity & ALCOA+

  • FDA data integrity expectations
  • ALCOA+ principles
  • Audit trail reviews
  • Electronic records compliance
  • Data governance
  • Common data integrity failures
  • Inspection readiness for data integrity

Module 13: Computer Software Assurance (CSA)

  • CSV vs CSA
  • FDA CSA guidance
  • Risk-based assurance
  • Critical thinking documentation
  • Unscripted testing
  • Validation efficiency improvements
  • Practical CSA case studies

Module 14: AI & GMP Compliance

  • AI in regulated environments
  • AI risks and opportunities
  • AI governance frameworks
  • Human oversight requirements
  • Documentation expectations
  • AI use cases in QA, validation and laboratories

Module 15: Product Release & Distribution

  • Batch release decisions
  • Lot disposition
  • Warehousing controls
  • Returned products
  • Recall management
  • Distribution compliance

Day 4 - Inspection Readiness, Investigations & GMP Excellence

Prepare for inspections, investigations, Form 483 responses, warning letter prevention, GMP auditing, and real-world case study workshops.

Module 16: Deviations, CAPA & Investigations

  • Deviation management
  • Root cause analysis
  • CAPA effectiveness
  • Complaint handling
  • Trending and metrics
  • Investigation best practices

Module 17: FDA Inspection Readiness

  • Types of FDA inspections
  • Inspection lifecycle
  • Inspection preparation strategies
  • Managing FDA investigators
  • Documentation readiness
  • Remote and hybrid inspections

Module 18: Form 483 & Warning Letter Prevention

  • Understanding Form 483 observations
  • Common FDA findings
  • Responding to FDA observations
  • Warning letter prevention
  • CAPA following inspections

Module 19: GMP Auditing Excellence

  • Internal audit programs
  • Audit planning
  • Audit execution
  • Auditor skills
  • Supplier audits
  • Risk-based auditing

Module 20: Real-World Case Studies & Workshop

  • Data integrity case studies
  • FDA inspection case studies
  • CAPA workshop
  • Mock inspection exercises
  • Group discussion and Q&A

Course Summary

Key GMP takeaways, compliance roadmap for 2026 and beyond, final questions and discussion, and certificate requirements.

Course Description

GMP Course Description

A practical 4 half-day GMP training program designed to help professionals understand regulations, strengthen compliance skills, and improve operational performance.

Course Overview

Learn the GMP rules, conduct expectations, and operational practices used across regulated manufacturing and laboratory environments.

Who doesn’t want their business or product manufacturing unit to function with great performance? This 4 half-day GMP training is designed to help you improve efficiency, strengthen your skills, and build credibility for a stronger career in the industry.

Good Manufacturing Practices include the regulations and operational standards that guide laboratory, manufacturing, quality, documentation, and compliance activities. This course presents those requirements in a beginner-friendly, practical format.

Whether you want to level up your role, support a regulated operation, or prepare for entrepreneurship, GMP knowledge can add meaningful credibility to your professional portfolio.

Topics Covered

The course covers GMP fundamentals, laboratory practices, documentation, production controls, inspections, investigations, and quality systems.

  • Basic regulatory norms and their benefits
  • Pharmaceutical GMP training online
  • Technical terms and their relevance
  • Training for QC laboratories
  • Techniques to adhere to regulations
  • Norms related to design and utilities
  • Good laboratory practices
  • Equipment and instrumentation norms
  • Introduction to Good Manufacturing Practice
  • CFR Title 21, Parts 58, 210, and 211 overview
  • GMP in the warehouse
  • Quality control laboratory design
  • Microbiology in the workplace
  • Cleaning and sanitation
  • Good documentation practices
  • Documentation and record keeping
  • Stability and training
  • Contamination control
  • Production controls
  • Packaging controls
  • Quality assurance and quality control
  • Corrective and preventive actions
  • Regulatory inspections
  • Deviations and non-conformances
  • OOS and OOT investigations
  • Writing an effective investigation

Who Will Benefit From the Course?

This GMP training is suitable for students, early-career professionals, experienced employees, and teams working in regulated environments.

R&D Associates and Research Scholars

Understand basic laboratory norms and prepare to pass quality inspections with stronger ratings.

Technical Experts in Operations

Strengthen knowledge of production facility protocols, equipment, tools, machines, and standard operating expectations.

Contract Laboratories

Support lab technicians with knowledge of raw material handling, storage, sanitation, hygiene, quality control, and laboratory structure.

Regulatory Affairs Personnel

Use GMP knowledge as a practical foundation for auditing, investigating, and inspecting laboratories and production units.

Undergraduate students looking for GMP certification online can also benefit from this beginner-friendly course format.

How to Attend

Join the live online training using a standard computer and internet connection.

All WCS Seminar live training programs deliver audio and visuals through GoTo Webinar. Participants only need a computer with internet access.

You do not need a GoTo Webinar account to join WCS Seminar live training courses. Registered participants receive an email invitation with the access details needed to join the meeting.

Know Your Faculty

Kelly Thomas, Head Of Quality Assurance (USA)

A seasoned Quality Assurance, Quality Control, and Regulatory Compliance leader with 25+ years of experience across API, biologics, medical devices, and combination products. Extensive expertise in aseptic and terminally sterilized manufacturing, along with all major dosage forms.

Proven track record of leading facility start-ups and successfully managing global regulatory inspections, including FDA and international agencies. Known for building strong quality systems, supplier management programs, and audit readiness frameworks.

👉 Brings practical, inspection-ready insights to help you strengthen compliance and avoid costly mistakes.