GMP LEARNING COURSE CURRICULUM
FOR IN HOUSE TRAINING PROGRAMS
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.
GMP 101 - THE BASICS
(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
AUDITING FOR GMP
(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
GMP TRAIN THE TRAINER
(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
GMP SUPERVISORY DEVELOPMENT COURSE
(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
GMP REINFORCEMENT SESSIONS
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
Documentation
Validation
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
ADDITIONAL REINFORCEMENT PROGRAMS
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.