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Quality Control Laboratory Compliance - cGMPs and GLPs  

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Senior directors, managers, supervisors and QC laboratory operations and practices comply with current good manufacturing practices and good laboratory practices. Quality Assurance, Quality Control, Research & Development

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Seminar Summary:

This course will examine the fundamental requirements for all QC laboratories subject to FDA inspection, recent trends from FDA inspection reports and enforcement actions (see full course description)

 

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Training Course Syllabus:


Quality Control Laboratory Compliance - cGMPs and GLPs  -  Quality Control Training Seminar

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:
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.


Quality Control Laboratory Compliance - cGMPs and GLPs Course Outline:

Day One (8:30 AM - 4:30 PM)

Registration Process: 8:30 AM – 9:00 AM

Session Start Time: 9:00 AM

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 Two (8:30 AM - 1:00 PM)

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

 

Seminar Summary:

This course will examine the fundamental requirements for all QC laboratories subject to FDA inspection, recent trends from FDA inspection reports and enforcement actions (see full course description)

print this agenda print agenda for the Quality Control Laboratory Compliance - cGMPs and GLPs training seminar

 view dates and locations for this seminar

 

 

 

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