Basics of Drug GMP CONTENT Package

Over 70 Pages of exclusive "how to" articles, PowerPoint Presentations and; Trainer instructional notes, and a Webinar Recording.Your CONTENT package includes:

➢ 1. GMP Pharmaceutical Regulations: An Introduction to Interpretations and Enforcement (Article)

➢Click here to view complimentary excerpt

➢ 2. Understanding GMP Part 210: A Baseline Document for Interpreting Part 211 Regulations (Article)

➢ 3. Basic Principles of Drug GMP: Meeting FDA Requirements (Webinar Recording - One hour in length)

➢ 4. Basic Principles of Drug GMP: Meeting FDA Requirements (PDF PowerPoint Training Presentation)

➢5. Introduction to Performing Gap Analyses, Audits and Risk Assessments – (Reference Article)

Click here to view complimentary excerpt

➢6. Introduction to Performing Gap Analyses, Audits and Risk Assessments (PDF PowerPoint Training Presentation)

➢7. Introduction to Performing Gap Analyses, Audits and Risk Assessments (Trainer Instructional Notes)

1. GMP Pharmaceutical Regulations: An Introduction to Interpretations and Enforcement (Article)

➢Click here to view complimentary excerpt

The pharmaceutical industry is regulated by the Food and Drug Administration (FDA). One of the more difficult issues with which we grapple with is that of compliance. The requirements of these regulations are enforced by the FDA. They cannot be avoided and cannot be overlooked.

Maintaining compliance with Good Manufacturing Practice (GMP) regulations is an ongoing process. FDA regulation requirements, their application and interpretation are continually changing to reflect the increased expectations of our society, and the ever-changing level of technological advancement that affect all areas of our industry In this article, you will be introduced to drug GMP regulations, their main focus, interpretation and FDA regulatory enforcement actions.

2. Understanding GMP Part 210: A Baseline Document for Interpreting Part 211 Regulations (Article)

GMP Part 210 serves numerous critical FDA regulatory purposes:

➢Specifically makes the connection of the GMP regulations to the Food, Drug & Cosmetic Act

➢Establishes the consequences of noncompliance

➢Contains definition of terms used in Part 211

This short article addresses the subject matter listed above and in the Part 210 definitions discussion, provides real-life examples for further understanding. Our author writes, “A solid understanding of Part 210 is necessary for interpretation and application of the regulations contained in Part 211.”

3.and 4. Basic Principles of Drug GMP: Meeting FDA Requirements (Webinar Recording and PDF PowerPoint Training Presentation)

This one hour webinar reviews the origins of GMP including:

➢Food, Drug and Cosmetic Act (FD&C) Act

➢Code of Federal Regulations Title 21 (CFR 21)

➢CFR 21 Parts 210 and 211, including:

• Subpart B: Organization and Personnel

• Subpart C: Buildings and Facilities

• Subpart D: Equipment

• Subpart E: Control of Components and Drug Product Containers and Closures

• Subpart F: Production and Process Controls

• Subpart G: Packaging and Labeling Control

• Subpart H: Holding and Distribution

• Subpart I: Laboratory Controls

• Subpart J: Records and Reports

• Subpart K: Return and Salvaging of Drug Products

5. Introduction to Performing Gap Analyses, Audits and Risk Assessments – (Reference Article)

Click here to view complimentary excerpt

This 22-page article reviews the basics of conducting gap analysis, audits and risk assessments. Topics include:

➢ FDA’s role in the inspection process

➢ FDA’s Quality System Inspection Technique (QSIT) program

➢ FDA access to results of QA audits

➢ How do we differentiate between a gap analysis and an audit?

➢ What is a gap analysis?

➢ What is an audit?

➢ Categories of audits

System

Process

Product

Element

➢ Preparing to conduct both a gap analysis and audit

➢ Why do we use a checklist?

➢ Conducting a gap analysis/audit

➢ Internal auditing and risk management

➢ The foundation for risk management

➢ Defining risk, risk assessment

➢ Determining system risk level

Low

Moderate

High

➢ Includes a table which is divided into risk level, definition and examples of severity of failures at the risk level

➢ Role of audits within risk management

➢ What is NOT the auditor’s responsibility

➢ Tools for evaluation and additional guidance (reference) for auditing and managing risk

➢ Several related examples of Warning Letters and Frequently Asked Questions and Answers are included.

6. and 7. PDF PowerPoint Training Presentation and Trainer Instructional Notes

20 slide PDF PowerPoint Training Presentation. Based on the subject matter presented in the reference content article series above. This PDF readymade presentation provides “core” subject matter content, and allows you to customize specific information within your presentation.

Trainer instructional notes, which contain 30+ discussion points related to the PowerPoint training presentation, are also included. Trainer instructional notes are designed to help focus your presentation on key points, engage attendees and encourage their participation in your training.

Basics of Drug GMP CONTENT Package is only $99.00: