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


Description: This course covers everything an entry-level employee needs to know about CGMP (current Good Manufacturing Practice) in a pharmaceutical 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 a series of lessons:

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

This is a self paced highly visual interactive e-Learning course, with a full audio voiceover, which can be taken online. It has a 16 question multiple choice Assessment which the Trainee can perform once they have completed the module. For the Certified option, a hard copy certificate is mailed to the Trainee, once they have achieved a score of 100% in their Assessment.

Lessons can also be purchased individually. Please see the “Also available” links below for further information on each of the individual lessons.


Contents: (1) Introduction to the Pharmaceutical Industry

This CompuPharma 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.

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 CompuPharma 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 CompuPharma 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 CompuPharma 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 CompuPharma 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)

(6) GMP Goals

This CompuPharma 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 the GMP responsibilities of employers and employee and the importance of procedures and records.

Objectives:

- Describe the purpose of procedures and records in GMP compliance
- Explain why GMP Regulations are important for ensuring drug product safety
- Specify the GMP responsibilities of companies and employees




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