The ICH Q10 Quality Manual

Duration: 90 Minutes
One of, if not the first document requests made by FDA, other regulatory bodies, or an external auditor is the index to the Quality Manual (QM). The Quality Manual Index (QMI) provides a quick overview of not only the organization of the quality system but also the relationships between multi functions. But perhaps, the most important objective of the QM is that it demonstrates that the company does or does not understand basic quality principles and really understands how inter-functional departments communicate and collaborate in decision-making that is so important to satisfying customer needs and requirements.
ICH Q10 Training
Instructor: Howard T Cooper
Product ID: 500329

Section 1.8 of ICH Q10 introduces the concept of the quality manual by briefly mentioning that it should include the quality policy, the scope of the quality system, management responsibilities within the quality system, and the identification of the Quality System processes along with their sequences, dependencies, and interdependencies. It also recommends using flowcharts and diagrams to visually define the quality system. In ICH Q10, the quality manual is defined by ISO 9000:2005 definition as a document specifying the quality management system of an organisation. (ISO)

However, this definition is lacking in content and does not provide sufficient information and data to be impactful. The purpose of this webinar is to provide a more in-depth look at the characteristics & structure of the quality manual and how it may be designed, or redesigned, to becoming very powerful quality tool and communication device , not only for the quality and regulatory activities, but to include all major inter-functional activities throughout the organization. The quality manual has been in existence for several decades. However, it in the preambles to the drug and device regulations, the FDA has not embraced importance of the quality manual. Even in "the FDA's publication of the quality systems approach this not require the quality manual. Hopefully, this is changing.

Why Should you Attend:
By attending this webinar, you'll gain very valuable insight into how quality systems work and function to satisfy user and patient requirements. You will gain a greater appreciation of the pervasiveness of the quality system and almost all functions of the company. Additionally, suggestions for writing, developing, and implementing the quality manual will be provided.

Objectives of the Presentation:
The objective of the manual is to first describe its content, expectations, and impact then discuss how it may improve all your operations.
  • Why has the FDA downplayed the importance of the quality manual in the past? Has this position changed?
  • Definitions of the quality manual
  • The ICH Q 10 approach to the quality manual
  • Juran's concepts of the quality manual
  • Juran's contents of the quality manual
  • The Quality and Technical Manuals
  • The Quality Manual is a product of collaboration between interdepartmental functions
  • The review and approval process for the interdepartmental review and approval of quality system content
  • Implementing the quality manual
  • Expediting the writing and approval of the quality manual.
  • Using the content of the quality manual as a tool for planning or revamping a quality system
  • The Internal Audit--Key to Maintaining and Improving the quality system
Who can Benefit:
  • Quality and Regulatory Affairs
  • Production
  • Human Resources
  • Engineering
  • R&D
  • Documentation Management
  • Purchasing
  • Finance
  • Maintenance
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
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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.

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