3-hr Virtual Seminar: The ISO 13485 and ICH-10 Quality Manuals for the FDA Regulated Industry

Why Should You Attend:

By studying relationship between quality and quality system, we can better understand the role of the quality manual. Juran* defines quality as “The totality of features and characteristics of a product or service that bear on its ability to satisfy stated or implied needs.” Then, he defines the quality system as “the organizational structure, responsibilities, procedures, processes, and resources for implementing quality management.”

The goal of the quality manual is to achieve product quality by formalizing the system for the design, manufacture, and marketing products satisfying multi-faceted needs and requirements.

For the health professional, it provides consistent and reliable product performance.

For the patient, it fulfills the need for restored health.

For the FDA, it provides documented evidence that processes are in control.

The quality manual is the core system, a set of, commonly owned procedures created through collaboration and multi-function approval, which ensure product quality and compliance.

By attending, this webinar you will learn

• Basic quality terminology for quality system elements to better understand ICH, ISO, & IMDRF (formerly GHTF) quality concepts
• How to plan and organize the manual by providing a Table of Contents(TOC) that is based on Product Lifecycle (PLC)
• How to prepare inter-functional or cross functional procedures that reduce the overall number of SOP’s
• Provide guidance for effectively processing the document workflow (writing, document control processing through review and approval, implementation and training, maintaining, and improving
• How to create the internal audit system that uses the TOC to organize the internal audit schedule based the procedure’s anniversary date
• How to improve the quality system

Areas Covered in the Webinar:

Part I-PowerPoint Presentation-Understanding and Describing the Quality Manual

1. Introduction, Purpose and Objectives
2. Defining the Quality System and Its Objectives
3. The Relationship Between the Quality System & The Quality Manual
4. How does the FDA define quality manual requirements?
5. The ICH Q10 & ISO 13485 Concept of the Quality Manual
6. The Combination Products Quality Manual
7. Concepts of the Quality Manual-Quality Gurus
8. Types and categories of documentation
9. The organizational structure of the company influences the structure of the quality manual
10. The Quality Manual is a product of collaboration between interdepartmental functions directed by quality, but all functions are represented
11. Developing the quality manual from start to finish then maintaining the system and performing internal auditing to determine effectiveness
12. The Structured Format of a Typical Quality Manual Procedure

Part II-Handouts-Flowcharts to Further Enhance Knowledge of the Quality Manual

1. Flowchart describing the development and establishment of the quality manual
2. Flowchart describing the typical process for the collaborative team to approve and implement a quality manual procedure
3. Example of the quality manual index
4. Expediting the writing of the quality manual
5. Example of a typical quality procedure emphasizing a flowchart format

Who Will Benefit:

• Quality and Regulatory Affairs Director
• Quality Control Laboratory
• Senior Management and Management Representatives
• Sales and marketing
• Purchasing
• External Auditor
• Internal Auditor
• Quality Manager
• Quality Assurance Manager
• Documentation Control Manager
• Quality Planner
• QA Director
• Quality Specialist
• Quality Analyst
• Senior Management

Howard Cooper
Consultant, EQACT Inc

Howard Cooper has over 40 years of experience facing the challenges of managing, designing, developing, implementing, and mitigating GMP quality systems in the pharmaceutical, medical device, & food industries. He started his quality career at Anheuser-Busch as a quality management trainee which exposed him to an advanced and preventative approach toward quality. He then took this experience to the medical device industry when the medical device amendments of 1976 were being written and promulgated. He quickly distinguished himself as a change agent and a forward-thinking quality leader.

He has worked with incubators, small companies, and large international corporations in the quality and regulatory affairs. In 2004, he became an independent consultant continuing his work to manage, develop, and implement quality. Mr. Cooper particularly enjoys sharing his experience with others to further develop them for successfully running quality operations.

He has developed several quality manuals from scratch and has revamped quality manuals as part of warning letter and consent decree situations.

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