Quality Control Laboratory Compliance - cGMPs and GLPs

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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 instructor Bill Schwemer is an ex-FDA official having more than 50 years of experience in dealing with FDA compliance matters that include 30 years he spent working with the FDA as a field Investigator, Director of Field Investigations, Assistant Associate Commissioner for Regulatory Affairs and Special Assistant to Deputy Commissioner for Policy.

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.

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

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

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AGENDA
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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

• 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
•  

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SPEAKER
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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 (marilyn.b.turner(at)nyeventslist.com ) 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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