How to Develop New Employee Orientation Programs for GXP Compliance

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How to Develop New Employee Orientation Programs for GXP Compliance

 Workplace performance is a top priority for both employers and new hires.  New employee orientation (NEO) programs are the perfect time to present these performance expectations to new employees. When developing effective NEO programs for GXP compliance, organizations should emphasize compliance and productivity.  Pharmaceutical consultants are the best resource to teach organizations how to create a successful NEO program.
 
·          New employees are specifically shown their workplace expectations including: GXP regulations and corporate policies and procedures.
 
·          NEO programs present new employees with how performance reviews work. In the past, new hires may not have experienced this process, and never been warned in advance what they can do to meet performance expectations.
 
There are many regulations and guidelines concerning GXP compliance; however, not all topics need to be covered. There are recommended guidelines, which are key components to include in NEO programs.
 
The following twelve components are important to the success of the employment lifecycle:
 
·          Advertising positions
·          Recruiting
·          Selection and hiring
·          New employee orientation
·          Probation
·          Training and development
·          Performance reviews
·          Promotions
·          Coaching and discipline
·          Separation
·          Benefits
 
The most important goal of a NEO program is that both employer’s and employee’s views are aligned.  
 
·          Engages new or transferred employees faster into the organization’s culture
·          Motivates new hires to perform successfully in their new positions
·          Lengthens new hires tenure over time  
·          Gives new hires a specific agenda and guidelines in a timely manner (compared to informal employee socialization or onboarding –when new hires aren’t orientated  until weeks or months later)
 
Follow this sample structure when presenting NEO programs to new hires or transfers:
 
·          Official welcome and mission statement explanation from organization’s officer
·          Presentation of workplace expectations
·          Explanation of organizational structure, culture and history
·          Human Resources (HR) presentation including: employee benefits, HR policies, beneficiaries, and confidentiality agreement/standards of business conduct
·          In regulated industries, include information about GXP and safety topics
 
According to the GMP (good manufacturing practice), task-specific technical training should be saved for the department/unit level.  However, according to the GMP the following domain (context) specific should be included:
 
·          OSHA (Occupational Safety and Health Administration) regulations
·          MSDS (Material Safety Data Sheets)
·          GXP regulations and compliance information
 
The following regulatory regimes should also be discussed:
 
·          FDA (Federal Drug Administration)
·          DEA (Drug Enforcement Administration)
·          DOT (Department of Transportation)
·          EPA (Environmental Protection Agency)
 
Another tip is to pose sample regulatory overlap scenarios and guide discussions accordingly.
 
·          Facilitate discussion of “standard operating procedures” (SOPs) and provide guidance as to how new hires can handle these situations according to SOPs.
·          Present principles and address how new hires should respond to regulatory complexity issues, especially when current procedures don’t work (i.e. appropriate versus inappropriate ways to handle regulatory complexity).
 
Include history of the FDA:
·          Include origin and development of drug safety regulations.
·          Summarize critical historical episodes such as:  Upton Sinclair’s The Jungle, thalidomide, Tylenol tampering, salmonella contamination, etc.
 
Because of the multiple topics covered, it’s important that all participating facilitators in the NEO process are well-prepared and have their SOPs clearly outlined. The NEO program needs to follow certain procedures and timelines.
 
Overall, NEO programs are crucial steps that new hires need to take, which allows them to better prepare for their first performance review. NEO programs are beneficial to both employer and employee, and important to the organization’s employment lifecycle from recruitment to separation.  Remember that when in doubt, pharmaceutical consultants can provide the proper guidance and recommendations.
 
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Rachel Clarkson
pharmaceutical consultants