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Compliance Trainings, Online Training Session
2013-06-18
This webinar provides a broad overview of ICH Q10, The Pharmaceutical Quality System. ICH Q10 is applicable throughout the pharmaceutical lifecycle. Unlike the FDA Quality Systems Approach limited applicability, ICH Q10 explains the application of quality principles and concepts to the regulations. The ICH Q10 concepts will be presented in a logical sequence that will show their applicability to the pharmaceutical product lifecycle to strengthen the link between pharmaceutical development and manufacturing activities.
This webinar focusses on The Quality Systems Approach (QSA) To Pharmaceutical Good Manufacturing Practices. The focal point of the QSA is drug substances and products but its principles apply to all FDA regulated industry. This guidance is written in a non-regulatory format explaining GMP concepts in a practical and easily understood way. This webinar uses many graphical aids to increase interest and enhance training. read more... Areas Covered in the Session : - Course Introduction, Objectives, & Quality Philosophy
- Defining the Role of Quality and Compliance in the Organization
- Why does ICH Q10-10, Pharmaceutical Quality Systems, Exist? Introduction, Scope & Objectives
- Arrangement & Organization of the ICHQ 10 Guidance
- Relationship to other regulatory requirements & regional regulations
- Enablers-Knowledge, Risk, & Design Management
- Introduction to the Pharmaceutical Product Lifecycle
- First Introduction to the Quality Manual
- Management Responsibility
- Pharmaceutical Quality System Elements
- Continual Improvement of Process Performance & Product Quality
- Continual Improvement of the Pharmaceutical Quality System
- Regulatory Body Enforcement
- Quick Review and Q&A
Who Will Benefit: - Middle and Senior Management
- Companies new to the FDA regulated industry
- Quality Assurance
- Quality Control
- Regulatory Affairs
- Senior quality management
- Compliance Director
- Vice Presidents
- Consultants
- Project Leaders
- Research & Development
- Sales and Marketing, Finance & Cost Accounting, and Procurement Departments
- Operations Department
- Human Resources who have an active or supporting role in Quality
- Other quality personnel who have the desire and/or potential to advance to quality leadership
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Organized by:
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Compliance Trainings |
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Invited Speakers:
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Howard T Cooper, President, EQACT, Inc., Independent Consultant, has over 40 years of experience facing the challenges of managing, designing, developing, implementing, and mitigating GMP quality systems in the pharmaceutical, medical device, and food industries.
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Deadline for Abstracts:
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2013-06-18
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Registration:
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Single Live : For One Participant - $249.00 Corporate Live : For Max. 10 Participants - $899.00 Single REC : For One Participant - Unlimited Access for 6 Months - $299.00
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E-mail:
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support@compliancetrainings.com
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