Comprehensive Approach to Compliance Training

This article describes the items that should be included when develop a training system for a pharmaceutical manufacturing environment. 

Pharmaceutical companies today are challenged to product quality products, contain costs, improve efficiency and speed new product introductions.  Ensuring personnel have the skills and knowledge necessary to perform their jobs safely and efficiently is critical to meeting these challenges.  Industry regulations indicated that the most important and potentially most hazardous factor in the manufacture of medicines is the human operator.  Success in developing critical skills and knowledge is related to a training effort that is an integral part of GMP principles.  The Code of Federal Regulations 211.25 under Personal Qualification mandates that. . . 


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A Comprehensive Approach to Training Program Design


This article presents a detailed methodology for designing competency-based training programs.


In the healthcare manufacturing industry each employee needs training in technical skills, SOP and awareness of the GMP regulations.  To satisfy this requirement, companies must adopt a systematic approach to training design, development and implementation.  FDA commentary suggests that training programs should be competency-based--that is based on the knowledge and skills an employee must possess to perform successfully in the job.  Effective competency-based training. . .


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Qualified or Certified?


Unclear about the difference between qualification and certification?  If so, you aren't alone.  Approximately half the people responding to a recent PDA benchmarking survey, "Status of Training in the Healthcare Manufacturing and Researching Markets", said their companies make a distinction between qualified and certified workers.  But when it comes to defining the difference between the two, people are likely to offer a variety of ideas about what the terms mean.  Here are some examples. . .


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"Read and Understand" vs "A Competency-Based Approach to Designing, Evaluating and Validating SOP Training."

 Each person engaged in the manufacture, processing, packaging or holding of a drug product shall have education, training, and experience, or any combination thereof to enable that person to perform the assigned function. (CFR 211.25, Personnel Qualifications).  Manufacturers typically use several systems to prepare personnel to perform their jobs.  These systems include establishing job descriptions, formulating Standard Operating Procedure (SOPs), setting performance guidelines, providing leadership and supervision--and training employees!  The goal of these systems is to enable employees to perform their assigned functions competently.  Such systems are considered to be "working" to the extent to which they prepare employees to do their jobs effectively.


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Selecting a Training Documentation and Recordkeeping System


Few things are more talked about in healthcare manufacturing training than documentation and recordkeeping.  Debates abound.  Some issues training managers are grappling with include:


What are the documentation/recordkeeping requirements?

Does the organization need an electronic documentation/recordkeeping system?

How does one select an electronic documentation/recordkeeping system?

Is validation required?


This article describes factors to consider when selecting an electronic Learning Management System (LMS).


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WHO-GMP Training Manual


This is a manual developed by the World Health Organization (WHO).  It includes information and examples on how to design, develop implement and evaluate GMP training programs.  


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