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
Laboratory Inspection and Auditing
Navigating through Maze of In-vitro Diagnostics (IVD) Regulations ...
Implementing UDI (Unique Device Identification) - Plan Now for Success
REACH and RoHS Compliance: Gain a Deeper Understanding
Ensuring Compliance with Advertising and Promotional Requirements ...
PV (Pharmacovigilance) Audit Strategy Planning - A Practical Approach ...
21 CFR Part 11 Compliance for SaaS/Cloud Applications
Regulatory Compliance for Dietary Supplements in the US ...
Quality and GMP Compliance for Virtual Companies ...
Latin America - Understanding Regulatory Compliance ...
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
FDA Guidance Q9 on Quality Risk Management
- By: Staff Editor
- Date: November 22, 2016
- Source: http://www.fda.gov/
FDA Guidance Q9 on Quality Risk Management
Risk management principles are effectively utilized in many areas of business and government including finance, insurance, occupational safety, public health, pharmacovigilance, and by agencies regulating these industries. In recent years, the importance of quality systems has been recognized in the pharmaceutical industry, and it is becoming evident that quality risk management is a valuable component of an effective quality system.
This guidance document offers a systematic approach to quality risk management. Specifically, it provides guidance on the principles and some of the tools of quality risk management that can be applied to different aspects of pharmaceutical quality including development, manufacturing, distribution, inspection, and submission/review processes throughout the lifecycle of drug substances, drug products, biological and biotechnological products.
Quality Risk Management Principles
The key principles of quality risk management are:
- The evaluation of the risk to quality should be based on scientific knowledge and ultimately link to the protection of the patient.
- The level of effort, formality, and documentation of the quality risk management process should be commensurate with the level of risk.
Risk Management Tools
Here is the list of some of the risk management tools:
- Basic risk management facilitation methods (flowcharts, check sheets, etc.)
- Failure Mode Effects Analysis (FMEA)
- Failure Mode, Effects, and Criticality Analysis (FMECA)
- Fault Tree Analysis (FTA)
- Hazard Analysis and Critical Control Points (HACCP)
- Hazard Operability Analysis (HAZOP)
- Preliminary Hazard Analysis (PHA)
- Risk ranking and filtering
- Supporting statistical tools
Related Training:
Quality Risk Management Overview for Pharma and Biopharma, ICH Q9/ISO 14971

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
