Your Shopping Cart
By using this site you agree to our use of cookies. Please refer to our privacy policy for more information. Close
Hello. Sign In
Your Account

Log In to ComplianceOnline
Welcome back! Please log in below to continue.
0
Cart
Toll Free:
+1-888-717-2436
+1-888-717-2436
Industries
- Banking & Financial Services
- BANKING & FINANCIAL SERVICES
- Banks and Credit Unions
- Financial Services and Trading
- Insurance
- Accounting and Taxation
- Life Sciences
- Hitech, Aero & Manufacturing
- HITECH, AERO & MANUFACTURING
- Quality & Safety
- Standards and Methodology
- Energy & Utilities
- ENERGY & UTILITIES
- IT Security
- Reliability (NERC / FERC)
- Quality and Safety
- Risk Management
- CPG & Retail
- CPG & RETAIL
- Retail Audit
- Quality & Safety
- Social Compliance
- Healthcare
- Food & Dietary Supplements
- Cross Industry Functions
Webinars
By Industries
Seminars
Quality Control Laboratory Compliance - cGMPs and GLPs
Process Validation Guidance Requirements (FDA and EU Annex 15: ...
FDA Recalls - Before You Start, and After You Finish
Biostatistics for the Non-Statistician
Data Integrity: FDA/EU Requirements and Implementation
Managing Domestic and Foreign FDA Inspections and the ...
Recordkeeping and Documentation in a GLP Laboratory ...
Reduce costs for compliance with data integrity: 21 CFR Part 11 ...
Change Control Best Practices - Avoiding Unintended ...
Technical Writing for Pharma, Biotech and Medical Devices
Standards
Aerospace
Agriculture and Farm Machinery
Automotive, Aircraft & Marine technology
Banking, Corp. finance & Sox
Biotech & Pharmaceutical Standards
Chemical technology
Civil engineering and construction
Computer Hardware
Electrical Engineering
Electronic Equipment
ANSI
Audit Net
BIN
BPA
Business Basics
Complianceonline
IT Governance
LabCompliance
Quality-Control-Plan
RCGLOBAL
SHOQ Quality Assurance Manuals
SEPT
Home
› Best Practices
ICH Q10 Pharmaceutical Quality System
- By: Staff Editor
- Date: November 27, 2016
- Source: http://www.fda.gov
ICH Q10 Pharmaceutical Quality System
Referred to as the pharmaceutical quality system, this internationally harmonized guidance is defined to assist pharmaceutical manufacturers by describing a model for an effective quality management system. In this guidance, the ICH Q10 model is referred to as the pharmaceutical quality system.
In the interest of public health, the ICH Q10 establishes regulatory and industry authorities’ support of an operative pharmaceutical quality system by enhancing the quality and availability of medicines across the globe. Implementation of ICH Q10 during the product lifecycle must facilitate innovation and continual improvement, and strengthen the link between pharmaceutical development and manufacturing activities.
Among other key areas, this guidance will look at:
- Relationship of ICH Q10 to Regional GMP Requirements, ISO Standards, and ICH Q7
- Relationship of ICH Q10 to Regulatory Approaches
- ICH Q10 Objectives
- Pharmaceutical Quality System Elements
- Application of Process Performance and Product Quality Monitoring System Throughout the Product Lifecycle
- Application of Corrective Action and Preventive Action (CAPA) System Throughout the Product Lifecycle
- Application of Change Management System Throughout the Product Lifecycle
- Continual Improvement of the Pharmaceutical Quality System
Related Training:
ICH Q10 - Moving From GMPs to a Pharmaceutical Quality System

Compliance Trainings

Pregnancy in the Workplace: Strategies to Protect Your Organization from Pregnancy Discrimination Claims
By - Christopher W. Olmsted
On Demand Access Anytime
By - Christopher W. Olmsted
On Demand Access Anytime

How to Vet an IRB: Expose and Fix Problems Before They Threaten Your Trial
By - Madhavi Diwanji
On Demand Access Anytime
By - Madhavi Diwanji
On Demand Access Anytime

Compliance Standards
Best Sellers
- Add to Cart
- Add to Cart
- Add to Cart
- Add to Cart
- Add to Cart
- Add to Cart
- Add to Cart
- Add to Cart
-
By: Miles HutchinsonAdd to CartPrice: $249
- Add to Cart
- Add to Cart
- Add to Cart
- Add to Cart
- Add to Cart
- Add to Cart
-
San Francisco, CA | Aug 6-7, 2020
-
Virtual Seminar | Jul 16-17, 2020
-
Virtual Seminar | Jun 18-19, 2020
-
Los Angeles, CA | Aug 20-21, 2020
-
Virtual Seminar | Jul 16-17, 2020
-
Virtual Seminar | Jun 25-26, 2020
-
Virtual Seminar | Jun 10, 2020
-
Virtual Seminar | Jun 3-4, 2020
-
Virtual Seminar | Jul 6-7, 2020
-
San Francisco, CA | Oct 22-23, 2020
-
Virtual Seminar | Jul 9-10, 2020
-
Virtual Seminar | Jun 3-4, 2020
-
Virtual Seminar | June 3-4, 2020
-
Miami, FL | Jul 29-31, 2020
-
Virtual Seminar | Jun 17, 2020
-
Provider: ANSIAdd to CartPrice: $142
- Add to Cart
- Add to Cart
- Add to Cart
-
Provider: ANSIAdd to CartPrice: $120
-
Provider: ANSIAdd to CartPrice: $250
-
Provider: SEPTAdd to CartPrice: $299
- Add to Cart
-
Provider: Quality-Control-PlanAdd to CartPrice: $37
- Add to Cart
-
Provider: At-PQCAdd to CartPrice: $397
- Add to Cart
- Add to Cart
- Add to Cart
- Add to Cart
You Recently Viewed
