Quality Control Laboratory Compliance

QC laboratory training
GxP Training Seminar
GxP Training Philadelphia
QC laboratory training
GxP Training Seminar
GxP Training Philadelphia

Quality Control Laboratory Compliance

1,599.00

*Use discount code 0M5YW12 before July 20th to receive $300 off registration*

August 30-31 2018
Philadelphia, PA

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

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

Seminar Fee Includes:

  • Lunch

  • AM-PM Tea/Coffee

  • Seminar Material

  • USB with seminar presentation

  • Hard copy of presentation

  • Attendance Certificate

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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
  • Laboratory Organization
  • Documentation and record-keeping requirements
  • Sample integrity requirements
  • Stability (shelf-life) studies

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
 Andrew Campbell

Speaker:

Robert C. Fish
Consultant, EAS Consulting Group

 

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.