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Th Food, Drug, and Cosmetic Act (FD&C Act)
Training Center

>
The HACCP AND
PREVENTIVE CONTROLS
 FOR Human Drugs Safety
Option 1. Self-Paced to be completed in 60 days
Option 2. On Zoom Instructor-Led
Option 3. On you site or in Hermosa Beach, CA 
THE HACCP AND
PREVENTIVE CONTROLS
FOR Animal Drugs and
Medicated Feed  Safety Course
Option 1. Self-Paced to be completed in 60 days
Option 2. On Zoom Instructor-Led
Option 3. On you site or in Hermosa Beach, CA 

THE HACCP AND PREVENTIVE
CONTROLS FOR
COSMETIC PRODUCTS 
SAFETY Course  
Option 1. Self-Paced to be completed in 60 days
Option 2. On Zoom Instructor-Led
Option 3. On you site or in Hermosa Beach, CA   

Table of Contents


Module 1. Introduction

 
Module 2. Definition of Food, Drug, and Cosmetics


Module 3. CGMP 21 CFR 310


Module 4. CGMP 21 CFR Part 311


Module 5.  CGMP Part 312


Module 4. PART 21 CFR Part 314—
APPLICATIONS FOR FDA APPROVAL
TO MARKET A NEW DRUG


Module 5. Pharmacokenetics, Pharmadynamics


Module 6. —The FDA Orange Book


Module 7. Generic Drugs


Module 8. PART 312—INVESTIGATIONAL
NEW DRUG APPLICATION


Module 9. —PART 320—BIOAVAILABILITY
AND BIOEQUIVALENCE
REQUIREMENTS


Module 10. The Categorization of Drugs


Module 11. The Federal Food, Drug
and Cosmetic Act


Module 13. Prescription Drugs and Over
the counter Drugs (OTC)


Module 14. OTC Drug Review Process
OTC Drug Monographs


Module 15. The FDA History of
Drug Regulations


Module 16. Pharmacogenomics


Module 17. Pharmacotoxicology

Module 18. Pharmocology

STEPS OF Wrtiting COSMETIC PRODUCTS
SAFETY PLAN

Module 21. Prerequisite Programs

Module 22. Preliminary Steps

Module 23. Conducting a Hazard Analysis-
The First Principle of HACCP

Module 24. Identify Critical Control Points (CCP)-

The Second Principle of HACCP 

Module 25. Establish Critical Limits-

The Third Principle of HACCP

Module 26. Establish Monitoring Procedures

The Fourth Principle of HACCP

Module 27. Establish Corrective Action
Procedures

The Fifth Principle of HACCP

Module 28. Establish Verification Procedures

The Sixth Principle of HACCP 

Module 29. Establish Record-Keeping and
Documentation Procedures

Module 30. HACCP Plan and System
Implementation,
Maintenance and Reassessment

Module 31. The Template for Writing HACCP Plans 

Module 32, Resources


Table of Contents

Module 1.Introduction to FDA Regulation
of Animal Drugs

Module 2. Chapter 1, Subchapter E –
Animal Drugs, Feeds,
and Related Products (500 to 589)
 
Module 3. Abbreviated New Animal
Drug Applications

Module 4. Animal & Veterinary

Module 5. Animal Drug Compounding

Module 6. Animal Food Additive Petitions

Module 7. Animal Food Ingredients
 
Module 8. Animal Foods & Feeds

Module 9. Approved Animal Drug Products
(Green Book)

Module 10. Classes of Major Food-Producing
Animals
for New Animal Drug Applications

Module 11. Color Additives in Foods

Module 12. Evaluation of FDA
Pre-market
Animal Food Programs and Plan
for Consultations

Module 13. Food Safety Modernization
Act and Animal Food

Module 14. Medicated Feed Labeling
for Manufacturers –
Getting it Right

Module 15. Medicated Feed
 
Module 16. Minor Use /Minor Species
 
Module 17. New Animal Drug Applications

Module 18. CURRENT GOOD
MANUFACTURING
PRACTICE FOR MEDICATED FEEDS
(21 CFR Part 225)

Module 19. NEW ANIMAL DRUGS
Regulation
(21 CFR Part 225)

Module 20. NEW ANIMAL
DRUGS FOR
USE IN ANIMAL FEEDS
(21 CFR Part 558

Module 21. Biological, Chemical,
and
Physical Contaminants
in Animal Food

Module 22. Introduction to the Application
for HACCP to Animal
Drugs

Module 23. Prerequisite Programs

Module 24. Biological, Chemical and
Physical Hazards of Animal Drugs

 Module 25. The Five Preliminary Steps

Module 26. The Seven Principle of HACCP    

Module 33. HACCP Plans and Systems
Implementation,
Maintenance and Reassessment

Module 34. The Template for Writing HACCP Plans

Module 35. Resources

Table of Contents

Module 1. Introduction

Module 2. Modernization of Cosmetic
Products Act (MoCRA)

Module 3. Title 21, Chapter 1,
Subchapter G - Cosmetics

Module 4.The Cosmetic Facility Registration

Module 5. The Fair Packaging and
Labelling Act (FPLA)

Module 6. The Color Additives Permitted
for Use in Cosmetics

Module 7. Cosmetic Color Additive Regulations

Module 8. Cosmetic Labelling Regulations

Module 9. American Dental Association
and Cosmetic Oral Care

Module 10. ISO 22716 2007
Cosmetic Standards

Module 11. Prohibited & Restricted
Ingredients in Cosmetic Products

Module 12. Allergens in Cosmetic Products

Module 13.The FDA 483 Form

Module 14. The Food Drug and
Cosmetic Act (FD&C)

Module 15.Therapeutic Cosmetics (Drugs)

Module 16. Non-Therapeutic,
Over the Counter,,
and Prescribed Cosmetic Products

Module 17. Cosmetic Products Labelling

Module 18. Third-Part Auditing of
Cosmetic Facilities

Module 19. Good Manufacturing
Practices
for Cosmetic Products

Module 20. Is It a Cosmetic, a Drug,
or Both (Or Is It Soap)

STEPS OF Writing COSMETIC
PRODUCTS SAFETY PLAN

Module 21. Prerequisite Programs

Module 22. Preliminary Steps

Module 23. Conducting a Hazard Analysis

Module 24. Identify Critical Control Points
(CCP)

Module 25. Establish Critical Limits

Module 26. Establish Monitoring Procedures

Module 27. Establish Corrective Action
Procedures

Module 28. Establish Verification
Procedures

Module 29. Establish Record-Keeping
and Documentation
Procedures   
Module 30. The Template for Writing
HACCP Plans

Module 31. Resources





    
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