Topic- 2-Day Virtual Seminar Quality Control Laboratory Compliance - cGMPs and GLPs.

Date- Apr 23-24, 2024

Time- 1 PM ET to 5 PM EST

Duration- 8 total hours 4Hrs/Day

Group Packages: Please contact [email protected]

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 approval

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.

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 01

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

Important: Please plan to bring a multidisciplinary group from your Company to gain the most from this very important seminar.

• In-Person Seminar going Virtual with increased learner satisfaction.
• Yes, attend this seminar from anywhere. We are making it real and more interactive – Here's a sneak peek:
• Our enhanced delivery process and technology provides you with an immersive experience and will allow you to access:
• The real-time and live presentation as in in-person events
• Private chat for company-specific conversation – the same as you would get in an in-person seminar
• Opportunities to connect with your peers to share knowledge at different times and have group discussions
• Live workshop activities
• Live Q&A during the event and offline Q&A assistance after the event
• As usual more content, activities and case studies and now adding homework for a comprehensive understanding

Additional service: (Personalized session)

We also do various similar customized events for our clients and it is specially tailored as per the client's requirement. We arrange calls between clients and our course instructors to better understand the training requirement and accordingly a training program is designed. The course duration ranges between 90 Mins and 12 hours. Most 6 hours and 12 hours of classes are split into 2 to 3 days considering customer convenience.

We have 500+ consultants who are associated with us and each have their own specialization example GxP, GMP,GLP, 21 CFR, Computer system validation, FDA Audit & Inspection, Bioassays, Design Control, Data Integrity, FDA regulation, Clinical compliance, and almost everything that falls under Risk, Quality and Compliance arena in the Life Science industry.

If you think that your team needs some kind of boost, update or refresher in Risk management and Regulatory compliance then let me know and we can design a highly cost efficient program for you.