San Francisco Professional Events List


Quality Control Laboratory Compliance - cGMPs and GLPs


Date
Nov 22, 2018 - 08:30 AM
Organizer
NY Events List
Venue
San Francisco
Location
San Francisco, San Francisco, CA

San Francisco,
California,
US,
ZIP: 94016
Phone:

Quality Control Laboratory Compliance - cGMPs and GLPs

 

*** LIMITED TIME OFFER: FREE $100 AMAZON GIFT CARD! ***
REGISTER TODAY!

 

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).

 

Seminar Fee Includes:

Lunch
AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar

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


AGENDA


Day 01(8:30 AM - 4:30 PM)


08.30 AM - 09.00 AM: Registration
09.00 AM: 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(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

 

SPEAKER

Robert c Fish

Robert C Fish
Consultant, EAS Consulting Group, LLC

Mr. Fish has been providing independent consulting services since 2003, joining EAS Consulting Group, LLC in November 2006. Prior to that he started work for AAC Consulting Group, Inc. (AAC) in April 1995 after serving 33 years with Food and Drug Administration (FDA). The last 6 years of that service he held the position of Director, Division of Field Investigations (DFI). He was responsible for general policy and guidance for the Agency’s domestic and international investigation activities. He also managed the foreign inspections' operations. Prior to that position, Mr. Fish was Director of Compliance at the Nashville District Office for 8 years and was also a Supervisory Investigator at the Nashville District Office for 8 years. Mr. Fish began his career as an investigator in the Minneapolis District Office in 1962, and subsequently served as an Investigator at the Grand Rapids Residence Post and the Detroit District Office. Mr. Fish is experienced in all aspects of FDA regulated products. He has expertise in compliance matters and Current Good Manufacturing Practice Regulations (GMPs) as they relate to pharmaceutical, dietary supplements, tobacco, device, and biologics manufacture. Further, Mr. Fish is ISO 9000 Lead Assessor Trained and is an AFDO Certified HACCP Instructor.

 

Please contact the event manager Marilyn ([email protected] ) below for:
- Multiple participant discounts
- Price quotations or visa invitation letters
- Payment by alternate channels (PayPal, check, Western Union, wire transfers etc)
- Event sponsorships

NO REFUNDS ALLOWED ON REGISTRATIONS
Service fees included in this listing.
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Event Categories
Keywords: fun, analysis, administration , Book , conference , development , food , Fun , industry , instrument




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