An E-Learning Course That Describes GMP Responsibilities of Employers and Employees and the Importance of Procedures and Records.

DUBLIN, Ireland -- Research and Markets (http://www.researchandmarkets.com/reports/c36953) has announced the addition of E-Learning Course: Essential GMP for Solid Dose Operators (Certified) to their offering.

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.

Topics covered:

--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

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.

--Introduction to the Pharmaceutical Industry

Introduces the Pharmaceutical Industry, what it manufactures, and the typical departments found in a pharmaceutical plant.

--Introduction to GMP for Finished Dose

What GMP is why it is important for safe guarding the end user, and the laws that govern it.

--Regulatory Agencies

Who regulates the pharmaceutical industry, how new drugs are approved, types of regulatory inspections, and the role of employees in inspections.

--Finished Dose Contamination Prevention

How finished dose products can be contaminated during production and how to minimize contamination through the use of PPE and good sanitation habits.

--Dress Codes for Finished Dose Manufacture

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.

--GMP Goals

Describes the GMP responsibilities of employers and employees and the importance of procedures and records.

A modern solid dose manufacturing facility faces a variety of regulatory and operational challenges including:

--Working in compliance with current industry GMP (Good Manufacturing Practice) regulations

--Reducing operating costs while maintaining product quality

--Increasing productivity and reducing levels of waste and rework 

These challenges cannot be successfully met without the input of a competent, well-trained workforce.

"Persons engaged in manufacturing, processing or packing of drug products do not have adequate training to enable those persons to perform the assigned functions."

- extract from FDA Warning Letter

"Essential GMP for Solid Dose Operators (Certified)" forms part of the EssentialOperator(TM) for Solid Dose facilities e-Learning curriculum, which is specially designed for operators in the solid dose industry. It provides critical knowledge in key areas such as current Good Manufacturing Practice (CGMP), equipment, processes, and health and safety issues.

Accessed via the Internet or your company's intranet, each EssentialOperator(TM) course is a multimedia learning experience that combines text, graphics, animation and audio to present critical knowledge in an engaging and interactive way.

Equipped with such knowledge, the transition from trainee to competent operator is made smoother and more efficient. Standard Operating Procedures (SOPs), with their own particular industry jargon, become easier to understand. On-the-Job Training becomes more effective as trainees comprehend what they see and hear. A thorough grasp of the principles of solid dose processes and the equipment used will contribute to improved operational efficiencies and a reduction in waste and rework.

"Training shall be in the particular operations that the employee performs and in current good manufacturing practice (including the current good manufacturing practice regulations in this chapter and written procedures required by these regulations) as they relate to the employees functions."

- extract from U.S. Code of Federal Regulations 21 CFR Part 211 Current Good Manufacturing Practice for Finished Pharmaceuticals

For more information visit http://www.researchandmarkets.com/reports/c36953