4-hr Virtual Seminar: The Quality Manual Ensuring Regulatory Requirements

Why Should You Attend:

To gain a greater understanding Management’s responsibility to direct, participate, and be proactive in the designing, developing, and commercialization of products to surpass customer requirements

• Management must participate in developing and implementing the quality manual
• Management must assure knowledgeable and competent individuals understand the functions for which they are responsible.
• New or problematic situations require leaders having the characteristics of a “change agent” that understands while quality systems have similar characteristics and principles, the nature of the product(s) and corporate environment create an “inherent uniqueness” modify the dynamics of internal and external challenges

To learn the objectives, purpose and scope of the quality manual and how to can be adapted to each different business environment

• The quality manual is a misnomer because it acts as a “central command” coordinating the activities of several departments and functions. It’s scope involves or touches all department functions
• It may also be known as Policies and Procedures, Operations Manual, Quality & Business Processes, etc.
• Whatever it may be titled, its main purpose and objective is a communication device to coordinate the work a multi-functional that have different business objectives.
• Scope includes all products and operations throughout the product lifecycle.

If your company is implementing a quality system, seeking opportunities for improvement, or in need of implementing regulatory body compliance requirements, the quality manual provides guidance and direction as the system is developed

If your company manufactures combination products, the quality manual can reduce the complexity of multiple and duplicative regulations

Help you to better understand the conflicting views of experts concerning the need for a quality manual. For example, ISO 9001:2015 does not require a formal manual. Although ICH Q10 requires a quality manual, the FDA has not shared this view when writing regulations and guidance documents

Learning Objectives:

• The quality manual consists of interdepartmental policies and procedures that create a communication tool for coordinating interdepartmental functions and activities
• The quality and technical manuals are interrelated and the quality manual “energizes” protection and integrity of the technical requirements
• The collaborating and negotiating to determine the most efficient and effective methods for achieving customer satisfaction, compliance, and the organizations objectives
• The Quality Manual is Developed Through Collaboration, Is Not Owned by Anyone, And Facilitates the Goal of Efficient & Effective Operations
• The Quality Manual Establishes t’s he Collaborative Process for Change Control
• You Have the Opportunity to Participate and make a personal impact on the system
• The Organization of the Quality Manual Is an Indication of Your Understanding of Quality Systems
• Policies outline the requirements and procedures actualize the policies. The forms provide the data to demonstrate the state of compliance and provide data for analysis
• Forms Must Be Tightly controlled
• The Quality Manual is Specific to Your Organization
• Regulatory and compliance requirements for the quality manual

Areas Covered in the Webinar:

Part 1-Learning about the Quality Manual

• Introduction, Purpose, and Objectives
• “The Quality Manual establishes a “legislative process for creating and implementing policies and procedures, guided by a quality policy to achieve the company’s mission.”
• Defining & scoping quality and the quality system
• Defining and Characterizing the Quality Manual
• Typical Quality Manual Contents
• What would life be like without a quality manual?
• When is a quality manual required according to regulations? Or standards?
• FDA
• ISO
• EU
• ICH
• IMDRF (Was GHTF)
• Organizational structure (brick-and-mortar versus virtual) impacts the approach to the quality manual
• Technical Manual Versus the Quality Manual
• Classifying and categorizing the types of documents in the quality manual.
• Change Control
• Documentation Management
• Record Retention
• The connection between the quality manual and the internal audit
• How about Documentation Management Systems?
• Part 11-Electronic Records

Part 2-Planning, Developing, and Writing Your Quality Manual-Learning by Example

• The ISO 9001:2015 concept of the corporate environment and quality planning
• Examples of quality manuals and their indexes & table of contents-The table of contents should create and demonstrate the quality system vision.
• Qualifications and experience required for quality manual authors and reviewers
• The logistics of review and approval of procedures and technical documents
• Implementing new and revised documents
• Establishing the internal audit system.

Who Will Benefit:

• Senior Management
• Manufacturers
• Documentation Management
• QA and QC
• Regulatory Affairs
• Engineering
• R&D
• Production
• Sales & Marketing

Instructor Profile:

Howard Cooper, has over 40 years experience in the pharmaceutical and medical device industry creating, implementing, managing & remediating quality systems. This experience has shown his leadership, organizing & problem-solving skills to develop quality systems from scratch or in the role of a change agent to remediate failing systems. This experience includes small and large companies operating in the US, Europe and Japan. He has worked with a wide variety of FDA regulated products such as medical devices, in vitro diagnostic reagents and instruments, in vivo diagnostics, pharmaceuticals (Tablets, capsules, injectables), biologicals, monoclonal antibodies), and combination products.

He is a Certified Biomedical Auditor (CBA), Certified Quality Manager (CQM), and Quality Auditor (CQA). His technical education is further complemented by his Political Science degree helping him understand the regulatory process; his work toward an MBA provides business insight. He is a member of ASQ, PDA, AAMI, RAPS, and SQA. He strongly believes that Quality is very influential in shaping successful operations. He knows how to use his leadership abilities to build organizational relationships that make systems operate effectively as well as to develop and empower people.

During experience described above, Mr. Cooper has implemented full supplier qualification systems and programs. This includes both consulting and employee roles.

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