Topics

Min¹

Outline

Movie

Inter-

active

LMS
Plug-In

21 CFR 211 - This topic summarizes the most important elements of 21CFR211. This is a great orientation to the regulation for new employees or serves as a quick refresher for seasoned employees.

35

Outline

$495

$695

$945

$49

Buildings and Facilities - This topic provides a review of the requirements of Building and Facilities issues well beyond Subpart C, Buildings and Facilities.  This program, uses many video segments from actual plant operations to review the essential elements of this Subpart.

Contamination Control - This topic discusses the sources of contamination and methods of preventing contaminating products. This is a great session for new employees, or as part of a preventive action as a result of contamination control breaches.

Equipment GMPs - This topic discusses the requirements of 21 CFR211 Subpart D - Equipment specifically the design and construction requirements for equipment including lubrication and coolants. The class addresses cleaning and maintenance requirements including automatic and electronic equipment. the class also covers the requirements for equipment identification, personnel training and required documentation.

Executive Session 2009 - Explore the common observations issued from 2008 in a neatly organized pareto chart along with the regulatory agency expectations. Learn to identify common sources of observations and what are the expectations of regulatory agencies.

Organization and Personnel  - This topic summarizes the essential elements of 21CFR211 subpart B, Organization and Personnel. This is a great orientation to this subpart for new employees or serves as a quick refresher.

Materials and GMP - This topic traces the GMP requirements from supplier qualification through to manufacturing and packaging. A solid review of 21 CFR 211 Subpart E, Control of Components, Drug Product Containers and Closures.

Production and Process Controls - This topic provides a review of the requirements of 21 CFR 211 Subpart F, Production and Process Controls.  This program, uses many video segments from actual plant operations to review the essential elements of this Subpart.

Proper Documentation Practices - This topic reviews the proper procedure for entering information into GMP documents, correcting errors in documents and highlights numerous acceptable documentation practices.  This is a great class for new employees or others who need to review GMP documentation. It also serves as a retraining component as a part of a preventive action in response to a documentation deviation.

Root Cause Analysis for Better Investigations - Having trouble resolving deviations? This topic reviews a successful model for investigating and identifying the root cause of deviations. This is a great review if you are considering our on site class on Root Cause Analysis.

Surviving and FDA Inspection - Learn what to expect, how to plan for an inspection, how to behave. This program has demonstrations of interviews and different response strategies.

Validation - Delve into the intricate rules and practices of validation. This course is based on the 2008 guidance document on validation.  Coming 4th Quarter 2009

Different uses depending for different needs

• Use in class room training

• Use for one-on-one training

• Use as a part of a preventive action

Use on dedicated PC or corporate server

• Classes taken on local PC or your corporate server
• Unlimited number of students may attend
• No user license expiration date
• Client controlled availability and scheduling
• Client controlled printing of completion certificates
• Content updates are available at discounted pricing
• Certificates can now be printed on line at the completion of the class
• Movie and interactive versions available

Learning Management System (LMS) Plug-in

• Classes are hosted in or with your corporate LMS
• Plug-ins are AICC or SCORM compliant
• You control class access and certificate issuance
• Content updates are available at discount pricing
• Separate quiz documents are available to insert the final exam into your corporate LMS assessment function
• Call for preference setting.

Hosted Learning Management System

• Classes are hosted on a third-party server
• 24/7 availability maintained for you
• Private access web page created for your company or site
• Content updates maintained for you at no extra cost
• Site administrator has access to monitor all student's performance
• Certificates printed at the completion of the class
• Call for price quote

Inquiry

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