Planned List of Topics
Click the link below to learn more about each class.

21CFR820 Overview

Buildings and Facilities

Contamination Control

Equipment

Materials and GMPs

Organization and Personnel

Production and Process Controls

Proper Documentation Practices

Root Cause Analysis

Surviving an FDA Inspection

Understanding Validation

Writing Procedures: Device Manufacturers

Effective Hand Washing - Coming Soon!

Writing Procedures - Coming Soon!

Topics

Min¹

Outline

Movie

Inter-

active

LMS
Plug-In

21 CFR 820 - This topic summarizes the most important elements of 21CFR820. This is a great orientation to the regulation for new employees or serves as a quick refresher for seasoned employees. Learn about 21CFR820 through the eyes of a fictitious medical device manufacturer.

90

Outline

$575

$775

1095

$99

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.

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.  

Writing Procedures: Device Manufacturers - Learn to write procedures quickly and thoroughly. Allan shares his experiences and techniques for writing procedures. This class is based on 30 years of experience writing procedures and teaching others to write them. This class is only for drug and device wholesalers, DME's and home medical device retailers. Pharmacists and pharmacy technicians responsible for procedures in their firm may also benefit.

Inquiry

Telephone

Email

Information via Email

(415) 487-3500

Click Here

Corporate and Consulting Services

(415) 487-3500

allan.dewes@skillsplusinc.com

Sales: Product and Services

(804) 938-4102

allan.dewes@skillsplusinc.com

Designated Representative - California Board of Pharmacy

(415) 487-3500

allan.dewes@skillsplusinc.com

Exemptee Certification - California Department of Health

(415) 487-3500

allan.dewes@skillsplusinc.com

Fax orders to

(415) 487-1926

Webmaster

(415) 487-3500

skillsplus@aol.com

Product and Service Support

Live computer based training tech support

(415) 487-3500

Allan

Live GMP Content questions

(415) 487-3500

Allan or Jackie