UPDATED Excipient GMP Compliance

Jerry Lanese
Instructor:
Jerry Lanese
Date:
Tuesday, July 14, 2020
Time:
10:00 AM PDT | 01:00 PM EDT
Duration:
90 Minutes

More Trainings by this Expert   Product Id : 503232

Price Details
$150 Live
$290 Corporate Live
$190 Recorded
$390 Corporate Recorded
Combo Offers
Live + Recorded
$289 $340 Live + Recorded
Corporate (Live + Recorded)
$599 $680 Corporate
(Live + Recorded)
Price Detail Options
Overview:

GMPs for Excipients is a developing area. There is no US or other geographical jurisdiction regulation covering this area.

Trade groups have issued GMPs and guidance documents and the regulators expect the pharmaceutical manufacturers to monitor excipient manufacturers, and all of the elements of the excipient supply chain to have appropriate controls in all of the areas found in the drug GMPs: organization, personnel, buildings, facilities, equipment, components, production, production controls, packaging, labeling, laboratory testing, and documentation, and assure that they demonstrate good manufacturing practices through the implementation of contemporary quality systems such as outlined in ICH Q10, Pharmaceutical Quality System.

A focus of the regulators is the use of risk management , as outlined in ICH Q9, Quality Risk Management, to identify potential problems and develop appropriate corrective and preventive actions.

Why should you Attend: This 90 minute webinar, “GMP Compliance for Excipients”, provides an understanding of Regulatory expectations and concerns for the production and control of drug product excipients.

Although the regulators may not have a direct responsibility for monitoring Excipient manufacturers, they do expect the drug product manufacturers to implement appropriate controls over excipient manufacturers and the production and control of pharmaceutical product excipients.

Pharmaceutical product producers monitor and control excipient manufacturers from pharmaceutical product development through routine production to ensure that the excipient has implemented appropriate GMPs and quality systems.

Areas Covered in the Session: This webinar will focus on the five key areas of GMPs:

  • People
    • Organization
    • Responsibilities
    • Education, Training, Qualifications
    • Contractors
  • Premises
    • Design
    • HVAC
    • Equipment
    • Qualification
    • Maintenance, Calibration
  • Processes
    • Material controls
    • Validation
    • Testing – approval, rejection
    • Rejecting
    • Process controls
    • Microbiological controls
  • Products
    • Testing
    • Release
  • Paperwork
    • Document system
    • Use, cleaning logs
    • Production records
    • Distribution
    • Data integrity

Who Will Benefit:
  • Senior Management
  • Middle Managers
  • Line Supervisors
  • Excipient Manufacturers
  • Distributors
  • Drug Product Manufacturers


Speaker Profile
John (Jerry) Lanese is an independent consultant with a focus on Laboratory Controls, Quality Systems and the components of an effective Quality System as they apply to the pharmaceutical and medical device industries and their suppliers to those industries.

He received a BA and MS from Middlebury College and a Ph.D. in Analytical Chemistry from the University of Michigan. Dr. Lanese focuses on the development of Quality Systems and trains extensively on related topics. He lectures throughout the world and presents training in all formats (lectures, seminars and webinars) on a variety of topics related to Quality Systems, GMPs, APIs, training, laboratory operations, calibration, change control, deviations and product reviews for clients and seminar, webinar and conference providers.

Jerry is a member of the Editorial Board of the Journal of GXP Compliance and co-edits a continuing column, "GXP Talk" in the Journal of GXP Compliance.


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