Good Distribution Practices (GDP) in Pharma- Part 3
Description:
This course is the third in a series that will provide you with the knowledge and information required to understand the Good Distribution Practice expectations placed on wholesale distributors.
In this course, we will focus on the remaining GDP components within a company and distributor network, including:
- Complaints, returns, and falsified products
- Outsourced activities
- Self-inspections
- Transportation
- Provisions for brokers
- Feedback A=activity
- Management’s responsibility activity
- And non-compliance examples
Curriculum for this course:
Course Introduction
| Course Overview | 38 secs |
| What You Will Learn | 38 secs |
GDP- Handling Medicinal Product Issues
| Complaints | 53 secs |
| Returns | 26 secs |
| Return to Stock | 20 secs |
| Falsified Products | 34 secs |
| Recalls | 40 secs |
GDP – Outsource Activities
| Principles | 35 secs |
| Contract Giver | 53 secs |
| Contract Acceptor | 55 secs |
GDP – Self Inspections
| Principles | 17 secs |
| Characteristics | 51 secs |
GDP – Transportation
| Principles | 37 secs |
| Storage Conditions | 52 secs |
| Containers, Packaging and Labeling | 55 secs |
GDP – Specific Provisions for Brokers
| Requirements & Restrictions | 50 secs |
| Documentation | 1 min 16 secs |
Activity
| Feedback of GDP | 14 secs |
| Benefits of GDP | 32 secs |
| Management's Impact | 23 secs |
GDP Non-Compliance Examples
| Family Dollar | 1 min 3 secs |
| Actions Taken | 31 secs |
| Dubrau & Roge | 43 secs |
| Thomazeutika Pharmahandels | 39 secs |
| Meba – Medizintechnik | 47 secs |
| Distripharma | 53 secs |
| Hellmut Ruck | 31 secs |
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General Info:
-
CEU Credits: 0.1 -
Course code: ELM-240 -
Duration: 25 mins -
Skill Level: Basic -
Language: English -
Final Exam: Yes -
Certificate of Completion: Yes
Related courses:
21 CFR Part 820 Subpart L – Handling, Storage, Distribution and Installation
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Pharmaceutical Microbiology and Industry Considerations
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How to be an Effective GMP Auditor – Part 1
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How to be an Effective GMP Auditor – Part 2
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How To Be An Effective GMP Auditor – Part 3
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Private: An Introduction to Good Manufacturing Practices (cGMP)
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21 CFR Part 11 – An Introduction
Course code: ELM-112
21 CFR Part 820 Subpart A – General Provisions
Course code: ELM-301
21 CFR Part 820 Subpart G – Production and Process Controls
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21 CFR Part 820 Subpart H – Acceptance Activities
Course code: ELM-308
21 CFR Part 820 Subpart I – Nonconforming Products
Course code: ELM-309
21 CFR Part 820 Subpart 0 – Statistical Techniques
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21 CFR Part 211 Subpart F: Production and Process Controls
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21 CFR Part 211 Subpart J – Records and Reports
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21 CFR Part 211 Subpart C – Building and Facilities
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21 CFR Part 211 Subpart H – Holding and Distribution
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21 CFR Part 211 Subpart G: Packaging and Labeling Control
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21 CFR Part 211 Subpart E – Control of Components, Drug Product Containers and Closures
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21 CFR Part 211 Subpart D – Equipment
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21 CFR Part 211 Subpart K – Returned and Salvaged Drug Products
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21 CFR Part 211 Subpart B: Organization and Personnel
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