Cgmp application for design & operation

CGMP Application for Design & Operation
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Design & Operation

Instructor Profile:
Mr. Jerry Dalfors has extensive (40+ years) of business administration,
consultative, technical and managerial experience in the development and
manufacture of highly regulated biopharmaceutical products including injectables,
biologics, medical devices and oral dosages. He has held permanent employee,
temporary employee and company representative management positions with a
multitude of the major pharmaceutical and biotechnology companies in the US.
He has worked with or assisted more than two dozen companies with the
establishment of controlled document/quality systems, FDA briefing and submittal
documents, project management of several multimillion dollar projects including
design, start-up and validation to assure fast track FDA approval by maintaining strict
regulatory compliance during all phases of engineering, construction, commissioning
and validation and more.

Description:
This presentation is intended to help manufacturers implement cGMP quality
systems and risk management approaches during commercial development and
operations after the initial preclinical studies, to meet the requirements of the FDA's
current good manufacturing practice (CGMP) regulations (2l CFR parts 210 and 211).
The FDA requires comprehensive quality systems highlighting the company's
consistency with the CGMP regulatory requirements for manufacturing human and
veterinary drugs as well as medical devices, including biological drug products. This
program also explains how manufacturers implementing good manufacturing practices
managed by quality systems can be in the best compliance with parts 210 and 211.

Why Should you Attend:
All individuals within a company manufacturing materials that are regulated by
the country's government to ensure the design and established operations are going to
be done in a way that will meet not only just the local regulations but wherever the
product might be shipped as well as doing all you can minimize patient risk and
increase the probability of profitability instead of paying outside contractors to fix your
errors.

Objectives of the Presentation:
The objectives of the presentation are to cover areas including:
 CGMPs and the concepts of current quality systems, including quality by design and
development, risk management, CAPA, Change Control, Management Responsibilities,
Resources, Manufacturing and Evaluation Activities.
 Terms and Definitions - with related acronyms
 Quality Management System - Quality = Profitability and does all it can to minimize
operator errors, Management Responsibility and GMP/Quality Commitment
 Quality Policy - General elements of the Quality Manual and Individual Training
Requirements for each job description.
 Human Resources - Individual employee files providing documented evidence of
required education or experience and related training for the individual's position
 Purchasing, Incoming Control and Raw Material Release
 Gowning, Environmental Control and Monitoring
 Product Testing, Inspection and Document Review for Final Product Release
 Incident Tracking, Change Control, CAPA and Annual Quality Review

Who can Benefit:
 FDA, ISO, PDA, ISPE, ASQ related employees
 Complaint - any written, electronic or oral communication that alleges deficiencies
related to the identity, quality, durability, reliability, safety, effectiveness or
performance of a product after it is released for commercial use.
 Lot or Batch - one or more components or finished product that consist of a single
type, product code, class, size, composition, or software version that are manufactured
under essentially the same conditions that are intended to have uniform
characteristics and quality within specified limits
 Manufacturing Material - any material or substance used in or used to facilitate the
manufacturing process, an intermediate or byproduct produced during the
manufacturing process, which is present in or on the finished product.

Live Session - How it works?
 Username and Password will be sent to you 24 hours prior to the webinar
 Presentation handouts in pdf format will be mailed to you
 Login to the session using the username and password provided to you
 Get answer to your queries through interactive Q&A sessions via chat
 Please let us know your thoughts and views at the end of webinar, your valuable
feedback will help us improve
 Get certification of attendance.
Recorded Session - How it works?
 A link will be provided to you upon purchase of the recorded session
 Please click on the link to access the session
 Presentation handouts in pdf format will be mailed to you
 Get certification of attendance.

Get Connected With Us:
www.onlinecompliancepanel.com

Cgmp application for design & operation

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Cgmp application for design & operation