E-Learning Course: Essential GMP for Solid Dose Operators (Certified)

Skillpad

This course covers everything an entry-level employee needs to know about basic CGMP (current Good Manufacturing Practice) in a solid dose facility. It introduces the pharmaceutical industry and its products. It looks at the historical basis for GMP and how industry legislation has evolved up to the present day.

The industry regulatory body FDA (Food and Drug Administration) and its functions are described in detail. The specifics of following CGMP are then covered with attention to dress codes, good health and hygiene habits, and contamination prevention in a controlled environment. Also covered are the implications of CGMP non-compliance for companies, employees and consumers.

This course consists of the following modules:

- Introduction to the Pharmaceutical Industry
- Introduction to GMP for Finished Dose
- Regulatory Agencies
- Finished Dose Contamination Prevention
- Dress Codes for Finished Dose Manufacture

Certificate

There is a 16 question assessment associated with each lesson within the Course and we offer a Certificate Service in which Users who achieve 100% in the assessment associated with each Lesson of a Course are deemed to have passed the Course, and are posted a Certificate.

(1) Introduction to the Pharmaceutical Industry

This Skillpad GMP Module is ideal for both new and existing employees in the Pharmaceutical Industry, who are required to work according to the regulations of 21 CFR 210 and 211, or Eudralex Volume 4. The Module introduces the Pharmaceutical Industry, what it manufactures, and the typical departments found in a pharmaceutical plant.

Course objectives:

- Describe the functions of the typical departments in a pharmaceutical plant
- Explain the difference between an API and a Finished Dose manufacturing plant
- List examples of different types of drug products manufactured by the pharmaceutical industry
- Name the typical departments in a pharmaceutical plant

(2) Introduction to GMP for Finished Dose

This Skillpad GMP Module is ideal for both new and existing employees in the Pharmaceutical Industry, who are required to work according to the regulations of 21 CFR 210 and 211, or Eudralex Volume 4. The Module explains what GMP is, why it is important for safe guarding the end user, and the laws that govern it.

Objectives:

- Explain GMP Regulations and where they are applied
- Explain why following GMP is essential in pharmaceutical production
- State the essential characteristics of a drug product
- Summarize the history of pharmaceutical regulations

(3) Regulatory Agencies

This Skillpad GMP Module is ideal for both new and existing employees in the Pharmaceutical Industry, who are required to work according to the regulations of 21 CFR 210 and 211, or Eudralex Volume 4. The Module explains who regulates the pharmaceutical industry, how new drugs are approved, types of regulatory inspections, and the role of employees in inspections.

Objectives:

- Describe the FDA regulatory inspection procedure
- Describe the purpose and work of regulatory agencies
- Distinguish between the different types of FDA regulatory inspections
- Explain the possible outcomes of FDA inspections
- Name the three main regulatory agencies

(4) Finished Dose Contamination Prevention

This Skillpad GMP Module is ideal for both new and existing employees in the Pharmaceutical Industry, who are required to work according to the regulations of 21 CFR 210 and 211, or Eudralex Volume 4. The Module describes how finished dose products can be contaminated during production and how to minimize contamination through the use of PPE and good sanitation habits.

Objectives:

- Describe how to minimize the risk of product contamination
- Describe Personal Protective Equipment (PPE) and its purpose
- Identify the main sources of contamination in a finished dosage form plant
- List the different types of contaminants that can be found in a finished dosage form plant

(5) Dress Codes for Finished Dose Manufacture

This Skillpad GMP Module is ideal for both new and existing employees in the Pharmaceutical Industry, who are required to work according to the regulations of 21 CFR 210 and 211, or Eudralex Volume 4. The Module explains dress codes and why they exist in the finished dose pharmaceutical industry. Examples of the different types of clothing required for the different areas within a pharmaceutical plant are shown.

Objectives:

- Describe why following dress codes is essential in a finished dosage form plant
- Explain why dress codes exist
- Name the different types of dress codes in a finished dose manufacturing plant
- Recognize the different types of Personal Protective Equipment (PPE)

Also available

• E-Learning Module: Introduction to the Pharmaceutical Industry
• E-Learning Module: Introduction to GMP for Finished Dose
• E-Learning Module: Regulatory Agencies
• E-Learning Module: Finished Dose Contamination Prevention
• E-Learning Module: Dress Codes for Finished Dose Manufacture

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• E-Learning Module: Finished Dose Contamination Prevention
• E-Learning Module: GMP Goals
• E-Learning Module: GMP - SOPs for Finished Dose
• E-Learning Module: Buildings & Facilities
• E-Learning Module: GMP - Records for Finished Dose
• E-Learning Module: Sampling
• E-Learning Module: Dress Codes for APIs