E-Learning Course: Essential GMP for Laboratory Analysts (Certified)
Skillpad
This course covers everything an entry-level analyst needs to know about CGMP (current Good Manufacturing Practice) in an analytical laboratory.
It introduces the pharmaceutical industry and its products. It looks at the historical basis for CGMP and how industry legislation has evolved up to the present day.
The focus then shifts to the laboratory - a typical routine of a laboratory analyst is presented, including responsibilities and duties. The different categories of tests - chemical, physical and microbiological – are described in detail. The importance of labelling and recording is emphasized. The concept and operation of a Laboratory Information Management System (LIMS) is also described.
The course continues with GMP rules of the laboratory. The proper procedure for receipt and storage of samples is described. Use of Standard Operating Procedures (SOPs) and correct completion of records is dealt with in-depth. Solution preparation and equipment preparation are also described along with testing procedures and recording and sign-off of results.
Finally, there is an in-depth treatment of out of specification (OOS) and atypical results, which includes possible causes, the investigation process and preventive measures.
This course consists of a series of lessons:
1) Introduction to the Pharmaceutical Industry (PGB-800)
2) Testing Categories (PGL-304)
3) Laboratory Information Management System (PGL-306)
4) Laboratory GMP (PGL-510)
5) Out of Specification and Atypical Results (PGL-500)
Lessons can also be purchased individually. Please see the “Also available” links below for further information on each of the individual lessons.
1) Introduction to the Pharmaceutical Industry (PGB-800)
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.
This is a self paced highly visual interactive e-Learning Module, 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.
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) Testing Categories (PGL-304)
This Skillpad Laboratory Module is ideal for both new and existing Laboratory employees in the Pharmaceutical, Biotech, and Contract Laboratory Industries. The Module explains the types of tests that a laboratory analyst performs. Topics include material and product testing and physical, chemical and microbiological tests.
This is a self paced highly visual interactive e-Learning Module, 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.
Course Objectives
- How pharmacopeias are used in laboratory testing
- The importance of archiving and stability testing
- The importance of standards in laboratory testing
- The main types of chemical, physical and microbiological tests
- The three categories of tests carried out in a laboratory
- The types of pharmaceutical material that require testing
3) Laboratory Information Management System (PGL-306)
This Skillpad Laboratory Module is ideal for both new and existing Laboratory employees in the Pharmaceutical, Biotech, and Contract sectors. The Module gives a description and explanation of a Laboratory Information Management System (LIMS) and how it works.
This is a self paced highly visual interactive e-Learning Module, 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.
Course objectives:
- How a LIMS shows if results have been accepted or rejected
- The different information stored in a LIMS
- The purpose of a LIMS
- What a LIMS is
- Why identification and security settings are important
4) Laboratory GMP (PGL-510)
This Skillpad Laboratory GMP Module is ideal for both new and existing employees in the Pharmaceutical Industries, who are required to work according to the regulations of 21 CFR 210 and 211, or Eudralex Volume 4. The Module explains gMP in the laboratory, from sample receipt, testing and recording of results to result approval.
This is a self paced highly visual interactive e-Learning Module, 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.
Course objectives:
- Complete laboratory records correctly
- Describe the general GMP rules that apply to the laboratory
- Describe what is done with data generated through sample analysis
- Describe what is involved in sample receipt and storage
- Explain how a sample result is released from the laboratory
- Explain what the laboratory is responsible for and the purpose of GMP in the laboratory
- Outline the steps that the analyst must take to prepare for testing in terms of solution and equipment preparation
5) Out of Specification and Atypical Results (PGL-500)
This Skillpad Laboratory Module is ideal for both new and existing Laboratory employees in the Pharmaceutical, Biotech, and Contract sectors. The Module discusses Out of Specification (OOS) and Atypical results. It includes their possible causes, the investigation processes and preventative measures.
This is a self paced highly visual interactive e-Learning Module, 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.
Course objectives:
- Define the terms OOS and Atypical results
- Describe how these results can occur
- Describe the sequence of steps taken to investigate OOS and Atypical results
- Describe ways in which OOS and Atypical results can be prevented
- Explain why OOS and Atypical results are important
Also available
Customers who bought this item also bought
All rights reserved. © Copyright 2013 Research and Markets WWW5
Terms and Conditions Privacy Policy Publishers Employment Opportunities Site Map Link to us Webmaster Affiliate Network
