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Course Description
Maintaining compliance in a Quality Control (QC) laboratory is essential to ensuring product safety, data integrity, and regulatory approval. This course provides a comprehensive understanding of Current Good Manufacturing Practices (cGMPs) and Good Laboratory Practices (GLPs), helping you navigate complex regulations and avoid costly compliance failures.
FDA inspection and oversight of quality control (QC) laboratories are essential elements of the agency’s evaluation of the compliance status of regulated companies representing multiple industries - pharmaceuticals, biologics, medical devices, as well as foods and cosmetics - as well as the contract QC laboratories which service these industries. Lack of compliance can result in severe regulatory actions, criminal liability, fines, and the inability to obtain product approvals.
This course will examine the fundamental requirements for all QC laboratories subject to FDA inspection, recent trends from FDA inspection reports and enforcement actions. In addition, this course will include a list of relevant regulations and guidelines and demonstrate how quality control and quality assurance personnel can monitor industry practices to stay “current” with FDA requirements (cGMPs and GLPs).
Learning Objectives:
Key goals of the conference will include learning:
- The basics of FDA law and regulations governing QC laboratories responsible for testing research materials, components of FDA-regulated products, and finished FDA-regulated products (pharmaceuticals, biologics, medical devices, cosmetics, and foods).
- Laboratory organization, personnel qualification and training requirements.
- Documentation and record-keeping requirements, including e-records and data integrity.
- Sample integrity requirements.
- Management and control of stability (shelf-life) studies.
- Analytical methods verification and validation.
- Management and control of laboratory instruments.
- Management and control of laboratory supplies.
- Proper conduct of laboratory investigations.
- Consequences of laboratory non-compliance.
Course Agenda
DAY 01
12:00 PM: Session Start
Basics of FDA law and regulations for QC laboratories
What is adulteration?
- Pharmaceuticals
- Biologics
- Medical Devices
- Foods
- Cosmetics
- What is CGMP?
- Pharmaceuticals
- Biologics
- Medical Devices
- Foods
- Cosmetics
- What is GLP?
- What is AIP?
- Contract Laboratories
- FDA inspection methodology
Laboratory Organization
- Organization
- Personnel qualification and training
Documentation and record-keeping requirements
- Standard Operating Procedures
- Analytical Methods
- Raw data (notebooks, print-outs)
- Document management (change control, retention)
- Part 11 (electronic records and signatures)
Sample integrity requirements
- Sample collection
- Sample delivery, handling, disposition
- Retain samples
Stability (shelf-life) studies
- Organization and management
- Storage units
- Analytical methodology
DAY 02
Analytical methods verification and validation
- Protocols
- Tests
- Documentation
Management and control of laboratory instruments
- Qualification
- Calibration
- Maintenance
Management and control of laboratory supplies
- Standards
- Reagents, chemicals
Proper conduct of laboratory investigations
- Out-of-specification results
- Out-of-norm results
- Root cause analysis
- Documentation
Consequences of laboratory non-compliance
Who Will Benefit from Quality Control Laboratory Compliance - cGMPs and GLPs Course
🔹 Quality Control (QC) & Quality Assurance (QA) professionals
🔹 Laboratory managers & scientists
🔹 Regulatory affairs specialists
🔹 GMP & GLP auditors
🔹 R&D and analytical chemists
🔹 Anyone involved in compliance within a GMP-regulated laboratory
Don't risk non-compliance—master cGMP and GLP requirements today!
🚀 Enroll now to ensure your QC laboratory meets global regulatory standards!
✅ Frequently Asked Questions (FAQ)
Q1: What is the focus of the Quality Control Laboratory Compliance course?
A: This course focuses on cGMP (current Good Manufacturing Practices) and GLP (Good Laboratory Practices) regulations, providing practical guidance on implementing compliance measures in Quality Control Laboratories within pharmaceutical, biotech, and related industries.
Q2: Who should attend this course?
A: The course is ideal for Quality Control Analysts, Laboratory Managers, Analytical Chemists, Regulatory Affairs Professionals, QA/QC Managers, Compliance Auditors, and Manufacturing Specialists seeking to strengthen their knowledge of laboratory compliance and regulatory best practices.
Q3: Are there any prerequisites to attend this course?
A: No formal prerequisites are required. However, basic knowledge of laboratory operations or quality management systems is recommended to fully benefit from the course content.
Q4: Will this course help prepare for regulatory audits?
A: Yes. The course covers best practices for documentation, process control, deviation handling, and audit preparation to help you ensure your laboratory is fully prepared for cGMP and GLP regulatory inspections.
Q5: Is this course applicable to both pharmaceutical and biotech industries?
A: Absolutely. The compliance principles of cGMP and GLP are applicable across pharmaceutical, biotech, cosmetic, and other life science industries that operate Quality Control Laboratories.
Q6: How long is the course and what is the mode of delivery?
A: The course is delivered online over 2 days, with a combination of interactive presentations, case studies, and practical examples, allowing flexible learning at your own pace.
Q7: Will I receive a certificate upon completion?
A: Yes, all participants who complete the course will receive a Certificate of Completion that demonstrates their understanding of Quality Control Laboratory Compliance practices related to cGMP and GLP.
What Our Learners Say About the Quality Control Laboratory Compliance Course
⭐⭐⭐⭐⭐
"Extremely valuable and practical course!
This course provided clear, in-depth insights into cGMP and GLP regulations specifically tailored for QC labs in the pharmaceutical industry. The case studies and real-world examples helped me implement better compliance strategies at my workplace. Highly recommended for lab professionals!"
– Quality Control Analyst
⭐⭐⭐⭐⭐
"Well-structured and easy to follow
As a Laboratory Manager, I appreciated how the course broke down complex regulatory concepts into actionable steps. The focus on documentation best practices and audit readiness gave me confidence in improving our lab’s compliance. The certificate added credibility to my professional profile."
– Laboratory Manager
Faculty Kelly Thomas
Highly experienced Quality Assurance / Quality Control / Regulatory Compliance leader with experience in API, biologics / biotech, both aseptic and terminally sterilized manufacturing processes, medical devices, drug / device combination products, and all pharmaceutical dosages (Sterile Injectable, OSD, Controlled Substances, Aerosols).
Over 20 years’ experience leading facility start-ups, PAI and Routine cGMP Surveillance inspections. Highly successful global regulatory and ISO compliance history with inspections including FDA, EMEA, IMB, JP, Health Canada, and ANVISA. Highly committed to implementing effective contract manufacturing, supplier management and Internal audit programs.
Strengths include developing staff, maintaining and developing budgets, implementing robust quality systems, communicating and implementing clear Key Performance Metrics (KPIs), conducting Quality Management Reviews and Executive Reports, implementing Lean Six Sigma programs, influencing and implementing positive change, and leading cross-functional teams.
High degree of quality understanding and ability to apply knowledge of global regulatory requirements particularly with process / equipment validation, new product and technology transfer, lot/process investigations, quality systems, quality control, data trending, lab equipment and validation.
Goal-oriented and self-motivated. Committed to quality, teamwork, continuous improvement and organizational success. Ability to motivate staff and create positive, team driven, goal achieving organizations.
