Mapping the ICH Q10 Quality System to ICH Q7A, Active Pharmaceutical Ingredients GMP and Part 210-211, Final Dosage GMP

Duration: 120 Minutes
The FDA and other regulatory bodies have attempted to define quality activities, roles, and responsibilities since regulation began. As you know, compliance describes the minimum level of quality required to maintain a state of control. Compliance has focused on documentation of quality activities and less on user/patient needs and requirements. Granted, regulation is needed to help overcome the inertia of human behavior.
Mapping ICH Q10 to ICH Q7A
Instructor: Howard T Cooper
Product ID: 500359

Quality, according to ICH Q9 defines quality as the degree to which a set of inherent properties of a product, system, or process fulfills requirements. However, to achieve quality, a quality system is required that implements quality policy and ensures that quality objectives are met. It is this quality system that ICH emphasizes throughout the guidance.

Thankfully, the ICH Q10 Committee has delivered a guidance that defines the scope of quality activities. The fact that ICH Q10 is considered a “guidance” and not a regulation enhances management’s acceptance as an important tool in meeting its own corporate objectives.

The ICH Q10 Quality System Model is very general because it represents the consensus of several regulatory bodies. Therefore, each regulatory body regulation impacted by the ICH Q10 must be correlated to ICH Q10 and vice versa. Sometimes there is no direct correlation so what do you do? How about conflicts? Such issues will be discussed for potential solutions.
  1. Introduction & Overview
    • What is the difference between compliance and quality?
    • What’s the relationship between quality and quality system?
    • What should be the boundaries of the quality system
    • Quality systems and quality gurus
    • Comparing quality systems
    • The FDA’s “Quality Systems Approach”
    • Industry Practice- A Friend To Quality and Compliance

  2. Mapping ICH-Q10 Key QS References to ICH Q10 & Part 211
    1. Pharmaceutical Quality System
      • Introduction (1.1)
      • Scope (1.2)
      • Relationship with ICH Q-10 8 Quality Manual

    2. MANAGEMENT RESPONSIBILITY
      • Management Commitment (2.1)
      • Quality Policy (2.2)
      • Quality Planning (2.3)
      • Resource Management(2.4)
      • Internal Communication (2.5)
      • Management Review (2.6)
      • Management of Outsourced Activities & Purchase Materials (2.7)
      • Management of Change in Product Ownership (2.8)

    3. Continuous Improvement of Process Performance in Product Quality
      1. Lifecycle Stage Goals (3.1)
      2. Pharmaceutical Quality System Elements (3.2)
        • Process Performance and Product Quality Monitoring System (3.21)
        • Corrective and Preventive Action (CAPA) (3.22)
        • Change Management System (3.2.3)
        • Management Review Of Process Performance and Product Quality (3.2.4)

    4. CONTINUAL IMPROVEMENT OF THE PHARMACEUTICAL QUALITY SYSTEM
      • Management Review of the Pharmaceutical Quality System (4.1)
      • Monitoring of Internal and External Factors Impacting the Pharmaceutical Quality System in parentheses 4.2)
      • Outcomes of Management Review and Monitoring (4.3)
Why Should you Attend:

Attendees will gain insight concerning the driving force of management involvement in creating the structure of the quality system. Each of us has a role achieving quality objectives. An understanding of quality systems helps management identify their responsibilities. Less experienced individuals will gain insight about quality systems and, therefore, will become more instrumental in achieving quality and organizational objectives.

By seeing the direct correlation of the ICH Q10 to the regulation, the attendee can better understand and implement the guidance.

Objectives of the Presentation:
The primary objectives of this presentation is:
  • To assist the implementation of ICH Q10 by correlating directly to the primary regulation
  • Provide potential answers to conflicts between the regulation and ICH Q10
  • To analyze the ICH Q10 Quality System Model in order to provide the attendee with information and insight that increases their understanding of the related quality system principles
  • To explain the workings of the Quality System model so that it may be designed and implemented to be in effective.
Who can Benefit:
  • Senior Management will become more aware of their responsibilities in the designing, implementing, and management of quality systems.
  • Quality Organization-Quality management will gain additional insight on how to develop and implement ICH Q10 quality personnel will better understand how the quality system operates as they implement ICH Q10 under direction of management.
  • Inter-functional groups that are an integral part of quality activities will better understand their roles as it relates to quality.
  • Pharmaceutical Companies
  • Contract Research Organizations
  • Manufacturing and Laboratory contractors to the industry
  • Medical Device Companies
Live Session - How it works
  • Username and Password will be sent to you 24 hours prior to the webinar
  • Presentation handouts in pdf formate will be mailed to you
  • Login to the session using the username and password provided to you
  • Get answer to your queries through interactive Q&A sessions via chat
  • Please let us know your thoughts and views at the end of webinar, your valuable feedback will help us improve
  • Get certification of attendance.
Recorded Session - How it works
  • A link will be provided to you upon purchase of the recorded session
  • Please click on the link to access the session
  • Presentation handouts in pdf formate will be mailed to you
  • Get certification of attendance.
$375
Recorded Session for one participant
Get life time access with download option!
Book this course
Pay Now
  $500.00 Training CD
Free shipment within 4 Working Days of placing the order. Get life time access for unlimited participants.
  $600.00 Training USB Flash Drive
Free shipment within 4 Working Days of placing the order. Get life time access for unlimited participants.
For multiple location please contact our customer care team +1-510-857-5896.
How it works
Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Howard T Cooper has over 40 years’ experience managing, designing, developing, implementing, and mitigating GMP quality systems in the pharmaceutical, medical device, nutraceutical, & food industries. He started his quality career at Anheuser-Busch as a quality management trainee which provided a very advanced and preventative approach toward quality systems. He quickly advanced to a managerial role experiencing responsibilities for quality management, quality system mitigation, and startup of new breweries. After leaving the brewing industry, he joined a medical device contractor when the Medical Device Amendments were being finalized. His first challenge was to establish a GMP system that met the needs of the large medical device clients that contracted with the company to produced finished medical devices. This very successful challenge led him to focus on startup quality systems and to mitigate failing quality systems.

His experience includes:
  • Designing and implementing Quality Systems from scratch in several startup operations.
  • Managing both single and multiple site quality operations
  • Assisted in revamping failing quality systems under warning letters and consent decrees
  • Advised large FDA regulated companies to improve their quality operations.

View More