GMP Executive Overview 
(Management's Role in Making GMP a Lifestyle)


As the title indicates, this course is targeted for Executive Management. This course provides a 3.5 hour overview focusing on the role of management in promoting the “GMP Lifestyle Concept” in your company.



          (Day one - Focus on the Concept of Compliance)

          (Day two - Focus on the Concept of Performance)


This program is targeted for middle management and provides not only the basic elements of GMP, but puts emphasis on the regulations and the elements involved in operating in a “GMP State of Control”, as well as how to make GMP a Lifestyle in your company and not just a regulation.


Day two focuses on performance and looks at the regulations and preamble to the GMP’s.  Day two of the program gets into the interpretation of the regulations and an assessment as to how well your company currently complies with the GMP regulations.


Many corporations conduct multiple sessions of day one so all management can attend and then provide day two for of the course to designated personnel who would benefit from the in depth follow up.



GMP Course 102 
GMP Introduction for Operators


This program is a four hour introduction to the GMP regulations for operators, temporary employees and contractors.

  • GMP’s, What are they and why do we need them?
  • Detailed discussion on each of the 10 Principles of GMP
  • The key to operating in a GMP “State of Control”
  •  The relationship of GMP’s and SOP’s
  • Controlling and Preventing Mix-ups, Errors and contamination
  • Your personal GMP audit checklist


GMP Course 103
GMP for Laboratory Personnel


This program is targeted for Laboratory Personnel and can be a one day course or two days if the bullets from the GMP 101 Basics course day one are also covered.


One Day Version: 

  • Examination of Lab requirement in CFR 21, Parts 211 and 58
  • Proper Use of Lab Notebooks
  • Implications related to the Barr Decision
  • Understanding requirements regarding standards
  • Calibration/cleaning of equipment
  • Principles of validating test methods and procedures
  • What the FDA looks for during a laboratory inspection

 NOTE: For Two Day version add bullets

                 from Basics 101 course day one.



GMP Course 104
GMP for Office/Support Personnel


This program is targeted to

Office and Support Personnel. 

This 2 hour program provides

an understanding of what the

cGMP regulations are and what

making GMP a Lifestyle means

to your company.


The focus is also on how the

GMP regulations impact office

and support personnel. What

are their responsibilities to the

GMP Lifestyle?



GMP Course 105
SOP Writing Workshop


This program is typically a one day workshop targeted at individuals in your company who are responsible for writing SOP’s. Generic SOP’s are used in the training. If you want the participants to develop internal SOP’s, extend the course to a day and a half.

  • FDA requirements and ISO perspective on procedures
  • Pre-requisites for SOP development
  • Process Flow Charting exercises as a means of outlining key process content required for well written procedures
  • Discussion of the Key Elements of a good procedure
  • SOP Preparation and Validating Techniques
  • SOP Approval Process and Controlling the distribution of your SOP’s
  • Change Control System for SOP’s
  • Procedural Training Techniques



GMP Course 106
(A tool for improving compliance and performance)


This course is a three day course which will introduce your internal auditors to the objectives and rudiments of auditing for performance and GMP compliance in your company. Part of the program is to actually apply learned auditing skills by conducting some internal audits on day three.



GMP Course 107
(Creating and Reinforcing the GMP Lifestyle)


This workshop is targeted for employees in your company responsible for conducting GMP training. This is a three day workshop and participants actually develop Lesson Plans for a number of GMP training sessions and develop the skills required to be a good, effective trainer.




GMP Course 108
(Tools and techniques for proactively managing performance)


This course is targeted towards supervisors and managers who want to develop critical competencies and skills useful in a regulated industry. These skills are required for good supervisors in all industries, but in this course we use examples and talk about applications in a GMP environment. This is a two day course.



GMP Course 109 
CAPA (Corrective and Preventative Action)/Root Cause Analysis


Problem Solving Techniques


What Is CAPA, a Deviation And Root Cause Analysis?


     A One or Two Day Workshop presented by GMP Learning


At the end of the session, participants will be able to: 

  • define corrective and preventative action when provided with various definitions from which to choose
  • describe in writing why CAPA  and root cause analysis are critical to your Quality System
  • identify when corrective and preventative action and root cause is required when provided with case studies
  • identify and cite sources of data and information required for CAPA compliance and root cause analysis
  • learn what root cause analysis really means and learn the tools that are used for root cause determination and analysis
  • verbally identify problems when provided with an out-of-control scenario




These programs are usually 2 to 4 hours in length and reinforce the concepts learned from the GMP 101 Basics course and the Operator Introductory Course.


            It is recommended that employees who are involved with direct product contact attend a reinforcement session twice a year and those who did not have direct product contact (support personnel) attend once a year. This is how you keep the GMP “Lifestyle” concept alive at your company.


            Reinforcement programs are customized to fit your current training needs and to update you on FDA hot topics and the latest trends in the industry.



Examples of reinforcement programs would be training sessions on each the following topics:

                        Written Procedures



                        Buildings and Equipment

                        Controlling for Quality

                        Auditing for Compliance

                        Defending Against Contamination

                        Doing the Job Right the First Time

                        Checks and Double Checks

                        GMP in the Workplace

                        FDA Inspection Process

                        Electronic Signature/Electronic Records

                        Pre-Approval Audit Preparations

                        Laboratory Controls

                        Elements of a Quality System



Brief Abstract of Content to Be Covered  


GMP Compliance – 60 minutes

            Overview of GMP History:

History of the 1906 Pure Food and Drug Act; 1938 Food, Drug and Cosmetic Act; 1962 Harris-Kefaver Amendments; 1963 Drugs GMP’s; 1969 Food GMP’s; 1976 Medical Device GMP’s; 1987 Process Validation Guidelines; 1989 Preproduction QA Planning; 1990 Safe Medical Device Act and its impact on Drug Manufacturers; 1997 Quality System Requirements.


GMP Makes Good Business Sense:

This section details the 4 Goals of GMP:  Safety, Productivity, Quality and Compliance. Elements that exist in a successful company involving Technical (Equipment, Buildings, Material) Controls, Operational (Policies, Procedures, Records) Controls, and Relational (Suppliers, Employees, Customers) Controls are discussed. The FDA focus, Management’s responsibilities and workers responsibilities are also detailed.


Ten Commandments of GMP:


GMP Interpretation – 30 minutes

            What does performing in a state of control really mean?

This section defines what control is and what the FDA focuses on to assure that we are operating in a “GMP State of Control”. The definition of control details that standards need to be set, training needs to occur, reinforcement of the training is required and auditing verifies that the standard is being met. Definitions by FDA are provided along with a Control Continuum that outlines the optimal area of State of Control


Examination of Parts 210 and 211

A brief overview that breakdown the key sections and subparts of CFR 21 Parts 210 and 211



Compliance Review for Change Control – 45 minutes

            Examination of Title 21CFR Part 211 Change Requirements

Various types of change control will be examined such as changes to written procedures, approval of change, change drafting, changes to drug product specifications, change review, test method change control, and the requirements of equipment and process changes. Also a discussion of the contents of a well written change control procedure.

GMP Documentation and SOP Requirements – 75 minutes

            Examination of Procedure and Record Requirements of the GMP

Examination of the principles for procedures and records as defined by the FDA. This section includes application exercises where groups examine documents for proper documentation practice.  This exercise helps participants understand the key concepts of the regulation and not only allows them to identify the required minimum procedures and records, but allows for a determination and discussion of your company’s status in regards to procedural and record keeping compliance.


U.S. vs. Barr Laboratories – 45 minutes

            Examination of the Barr vs. U.S. court decision

Lecture and discussion of the Barr court decision and the results that impact drug companies to this day.  We will discuss how what constitutes an OOS and how to investigate a single and multiple out of specification result.  Elements from the Barr decision that are found in the FDA guideline document for inspection of QC labs will also be discussed.  Elements that need to be in your OOS SOP will be identified and clarified via interactive exchange between facilitator and participants.


GMP Requirements for Calibration and Maintenance – 90 minutes

            Calibration, maintenance and cleaning of equipment are addressed

This section will cover equipment maintenance, calibration and operation. We will discuss maintenance, calibration, training, change control, equipment cleaning, validation and log book requirements.


Label Control – 60 minutes

            Examination of label control and operational requirements

Elements of label printing, storage, correctness, copy approval, area inspection, examination,      Issuance, required information on samples, master copies, material labels, reconciliation, records, Approval/rejection, handling, layout, stacking, cutting, receipt, identification are all items that will be discussed during these 60 minutes.


Preparation for PAI inspections – 90 minutes

            What you need to know about PAI’s

Discussion will focus on what a Pre-approval inspection is and how it differs from a routine or for cause inspection.  The objective of what a PAI is intended to be along with a review of the latest FDA guide to preparation of PAI’s.  A checklist for PAI preparation will be examined and details of how your company should prepare will be discussed.



GMP Requirements for Buildings and Equipment – 60 minutes

            Review of specific building and equipment requirements

This hour will be a specific discussion on what the FDA means when they say that buildings need to be in a good state of repair. 

Explain the rationale for equipment and facility design and selection

Explain the requirements for appropriateness of equipment and facility use

State the requirements for equipment and facility cleaning

            State the requirements for equipment and facility documentation


Development and Technology Transfer Reports – 60 minutes

            Focus on technology transfer as it relates to three key groups

Technology transfer requirements related to upper management, research and development and manufacturing will be discussed during this session.  Each department plays a key role and has specific duties and responsibilities as they relate to a smooth, effective and efficient transfer from clinical studies to full scale production.


Regulatory Readiness – 60 minutes

            Getting ready for an FDA inspection

This section covers in detail the “dos” and “don’ts” during an FDA inspection and the consequences of compliance and non-compliance. We will also review a 15 question test covering key points to know for FDA inspections.


FDA Compliance Trends and Issues – 2 hours

Current Trends and issues within the FDA that affects our industry

We will also define regulatory terminology and examine some 483 items of recent.  A close look at the FDA systems approach to inspection and details on elements of each of the 6 quality systems that are part of the 7356-002 FDA will be detailed.  We will go step by step through a checklist that details the specific areas of focus that the FDA will examine during an inspection.  Review of current 483 issues and warning letters


Preparation for Handling FDA Inspection – 75 minutes

What the FDA looks for During a Routine Systems Inspection:

            Discussion of what an FDA briefing file is and how to use it for FDA regulatory

inspections. Review of 15 Question test items regarding inspections. A detailed discussion on what a 483 form is and how to respond to 483 items.  We will also discuss warning letters and focus on how to react to a warning letter issue by the government.

We will also visit the latest vital statistics regarding issued 483’s, warning letter, number of recalls, and other regulatory activity over the past 6 years.