Services

EHS & Training

Leveraging Local Resources

In order to establish compliant operations, life science companies expanding into emerging global markets often need to hire and train local resources, thus creating a stable workforce within different cultures, reducing cost, and benefiting from local government tax incentives.

We Can Assist You

That’s where we can help. For more than 12 years, Mentor Technical Group (MTG) has been recruiting and training resources to work in life science companies in the following operational areas:

  • cGMPs and cGLPs Training and Education
  • Quality Control and Compliance, including CAPAs and CDs
  • Commissioning & Qualification
  • Calibration, Instrumentation, and Controls
  • Facilities Management and Critical Utilities
  • Maintenance and PM Management
  • Manufacturing Operations

Our Knowledge and Experience

MTG has the familiarity and experience with the FDA and similar international agencies to ensure compliance with regulatory training, safety, and efficacy guidelines. Mentor Technical Group:

  • operates within a compliant Quality Management System
  • is a Certified Minority Supplier (MBE)
  • has earned ISO 9001:2008, ANSI/NCSL Z540-1-1994, and MIL-STD 45662A Certifications
  • offers an ISO/GMP Training and Coaching Program
  • services Fortune 500 companies in six different global markets
  • is staffed by 500 highly-trained employees

Our Core Capabilities

Our trained and knowledgeable resources have the knowledge and experience to achieve all of your global Training and Coaching Program requirements for:

  • cGMPs and cGLPs for US FDA Title 21 CFR Parts 211, 680, and 820
  • Quality Management Systems, including SOP Development and Training
  • Manual, Electronic, and Software Data and Information Management
  • Documentation Preparation and Retention
  • Change Management Systems and Controls
  • Particular Operational Employee Performance
  • Employee Familiarity with Current cGMP Requirements

Our Clients

MTG’s client list of blue-chip life science companies includes, among others:

  • Abbott
  • Allergan
  • AstraZeneca
  • Bausch & Lomb
  • Baxter
  • Bristol-Myers Squibb
  • BSCI
  • Cardinal Health
  • GlaxoSmithKline
  • Johnson & Johnson
  • Lilly
  • Medtronic
  • Merck
  • Novartis
  • Sanofi  
  • Roche
  • St. Jude
  • Watson

Our Training Program Process

To determine the curriculum needs and guidelines for a global Training and Coaching Program that will achieve and ensure your compliance with FDA global regulatory requirements, MTG begins by performing an assessment of your company’s Quality Management System and, following a Training Program Analysis, developing a sequence of planning steps that ensure the overall program objectives will be achieved.

Needs Assessment

Instructional Objectives

Program Design

Implementation Guidelines

Evaluation Criteria

Needs Assessment

The Needs Assessment begins with a gap analysis between the current compliance situation and what would be required to achieve regulatory compliance. This process determines:

  • your expectations
  • existing and required competencies and skills
  • areas for performance improvement
  • competencies challenges and solutions
  • training priorities and schedule

Instructional Objectives

Upon successful completion of the MTG Training and Coaching Program:

  • your employees will have acquired the knowledge and hands-on experience to perform particular operations in compliance with your Quality Management System
  • you will have documented evidence with which to demonstrate to the FDA you’re your employees have the education, training, and experience—or any combination thereof—to perform their assigned functions

Program Design

The Program Design phase identifies the:

  • resources to develop the Training and Coaching Program
  • training curriculum requirements
  • training location (on-the-job, classroom, videoconferencing)
  • training materials (workbooks, videos, webinars, etc.)
  • learning techniques (lectures, role play, simulations, etc.)
  • training instructors

Implementation Guidelines

The Training and Coaching Program should be implemented in strict compliance with the Program Design criteria to ensure:

  • achievement of your expectations
  • compliance with the Quality Management System
  • accumulation of adequate evidence to demonstrate your compliance with the FDA’s requirement for education, training, and experience—or any combination thereof—that enables your employees to perform their assigned functions
  • program effectiveness through Evaluation Criteria

Evaluation Criteria

Creating a cost-effective workforce that can achieve established performance metrics is a key driver for companies expanding into emerging global markets. The Training and Coaching Program should describe Evaluation Criteria that ensures:

  • FDA compliance
  • achievement of operational performance metrics

Curriculum Requirements

We tailor the Curriculum Requirements to achieve your specific Training and Coaching Program needs. They can include, but are not limited to:

  • cGMPs and cGLPs Training and Education
  • Quality Control and Compliance, including CAPAs and CDs
  • Commissioning & Qualification
  • Calibration, Instrumentation and Controls
  • Facilities Management and Critical Utilities
  • Maintenance and PM Management
  • Manufacturing Operations

Knowledge Transference

The ability of the trainer, mentor, or instructor to effectively transfer the knowledge required for the student/employee to be able to perform the particular operations efficiently is the key factor to a successful Training and Coaching Program. All MTG trainers possess the skill sets required to:

  • train others in a structured classroom environment
  • perform particular operations within the operations environment

Classroom Training and/or Videoconferencing

Based upon your requirements, MTG can provide local classroom training or employ videoconferencing within your site or at a remote training facility. Keep in mind that many curriculum subjects are most effectively taught in a classroom environment. These include:

  • cGMPs and cGLPs Training and Education
  • SOP Development and Training
  • Quality Control and Compliance, including CAPAs and CDs

On-the-Job Training

In addition to classroom instruction, MTG provides on-the-job training that gives the student/employee the kind of hands-on experience that is difficult to simulate in a classroom environment. This training includes:

  • Commissioning & Qualification
  • Calibration, Instrumentation, and Controls
  • Facilities Management and Critical Utilities
  • Maintenance and PM Management
  • Manufacturing Operations

Your Best Solution

Your most effective option for creating and implementing a Training and Coaching Program for your employees is to team up with a global training and coaching partner such as Mentor Technical Group that is:

  • well-versed in local resource skill sets and capabilities
  • experienced in identifying resources with the requisite qualifications
  • capable of developing an effective training curriculum
  • familiar with technical training requirements
  • highly experienced with FDA and ISO inspections and audits
  • capable of offering classroom and videoconferencing training
  • familiar and experienced with direct, hands-on work

Our Commitment

MTG is committed to providing global clients like you with the technical and engineering services to achieve your specific local resource requirements, including:

  • identifying trained and experienced outsourced resources
  • recruiting local resources with the required skill sets
  • hiring and training local resources
  • training and certifying your current resources
  • mentoring and coaching your current employees
  • transferring local MTG-trained resources to you

Why Us?

There are at least six good reasons why you should entrust us with the task of creating and implementing a Training and Coaching Program for your employees. Mentor Technical Group possesses the:

  • requisite knowledge of local resource skill sets and capabilities
  • extensive experience required to identify resources with the necessary qualifications
  • demonstrated ability to develop an effective training curriculum
  • necessary working knowledge of technical training requirements
  • critically important direct experience with FDA and ISO inspections and audits
  • prerequisite classroom and video conferencing training capabilities
  • proven direct, hands-on work knowledge and experience.

Our Added–Value Proposition

At MTG, we see ourselves as a global partner committed to meeting or exceeding all your Training and Coaching Program requirements. And we go a giant step further by providing you with a complete, one–stop solution, thus ensuring that your employees and local resources receive effective training based upon demonstrated performance and continuous improvement, while enjoying reduced cost through consolidation.

Contact Us Today

Our job is to create and implement a Training and Coaching Program that ensures your employees and local resources are properly prepared to perform their assigned functions in compliance with all applicable regulations and requirements. Give us the opportunity and we’ll get the job done.