Quality Control Laboratory Compliance - cGMPs and GLPs


Starting at

$1599

Premier price: $1519 (save 5%)

Single registration

Buy Now

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.

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(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
Seminar (Price/Register)
Seminar Fee Includes:
Lunch
AM-PM Tea/Coffee
Seminar Material
Attendance Certificate
$100 Gift Cert for next seminar

Other Registration Option
  1. Download the Order Form
  2. Fill this form with attendee details & payment details
  3. Fax your PO to 1-888-883-7697 or,
  4. Email it to cs@compliance.world

Payment Mode

By Check -

Pay your check issued from the payee to "Redstone Learning Inc." (Our Parent Company) and mail the check to –
Compliance.world (Redstone Learning Inc.)
1180 Avenue of the Americas,
8th Floor, New York,
NY 10036

  Media Partners

If you wish to partner with us for this event

please contact us: partner or
call us: 1-866-978-0800

Media Partner Benefits

  • Logo and company data on the event website.
  • Logo on the conference material distributed during the conference.
  • Media Partner’s brochure distributed along with conference material.
  • Logo on all the mailings before and after the event.
  • 10% discount to media partner's subscribers.

Media Partner to do

  • Banner (min 728x90 or 468x60) on the Media Partner website.
  • Insertion of the event in the event calendar, both printed and/or online.
  • Announcement article of the conference on the Magazine and/or Website.
  • Dedicated email blast to all subscribers of Media Partner.
  • Article on the Magazine and/or Website after the conference.

  Sponsors

If you wish to partner with us for this event

please contact us: sponsor@compliance.world or
call us: 1-866-978-0800