Quality Control Laboratory Compliance
CGMPs and GLPs
Course Description
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
- 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.
WHO WILL BENEFIT?
Senior directors, managers, supervisors, and those who have responsibility for ensuring that QC laboratory operations and practices comply with current good manufacturing practices and good laboratory practices.
- Quality Assurance
- Quality Control
- Research & Development
DAY ONE & DAY TWO
I. 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
II. Laboratory Organization
A. Organization
B. Personnel qualification and training
III. Documentation and record-keeping requirements
A. Standard Operating Procedures
B. Analytical Methods
C. Raw data (notebooks, print-outs)
D. Document management (change control, retention)
E. Part 11 (electronic records and signatures)
IV. Sample integrity requirements
A. Sample collection
B. Sample delivery, handling, disposition
C. Retain samples
V. Stability (shelf-life) studies
A. Organization and management
B. Storage units
C. Analytical methodology
DAY THREE
VI. Analytical methods verification and validation
A. Protocols
B. Tests
C. Documentation
VII. Management and control of laboratory instruments
A. Qualification
B. Calibration
C. Maintenance
VIII. Management and control of laboratory supplies
A. Standards
B. Reagents, chemicals
IX. Proper conduct of laboratory investigations
A. Out-of-specification results
B. Out-of-norm results
C. Root cause analysis
D. Documentation
X. Consequences of laboratory non-compliance
CERTIFICATION
Successful participants will receive Peganix’s Certificate of Completion.
All attendees to a Peganix accredited course receive a Certificate of Accreditation acknowledging their training and their journey to New Skills, New Thinking. Independent research has verified that this recognition is highly valued by your employees.
In-person / On Location
Our team and, your health and safety are our top priority. We have limited our registration numbers to 25 people per meeting to provide enough distance per person, hand sanitizers with face masks will be provided for all attending delegates and a temperature scanner will be available at the venue.
Our team and the venue are fully prepared to assist you.
Live Online / Virtual
Registered delegates can log in and join the live meeting. The online platform will not limit your participation, as you can engage on the platform via live chat text, audio, or video. All live meetings will be recorded and made available to all participants.
At any point, you’re not feeling too well to attend the in-person meeting you can simply log in at home and join live online.
- 07, 08 & 09 July 2021
- Durban, South Africa
- In-Person
- Virtual
-
ZAR7, 999.00 (Virtual)
ZAR15, 999.00 (In-Person)
Contact Us
- registration@peganix.com
- +2711 041 0181
- +2768 053 6221