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10 Good reasons for training, learning, and development in Biotechnology Products testing and validation Regulatory Compliance


The university education biotechnology professionals have are often found insufficient for performance at their jobs. Effective training programs that cover the current areas of work go a long way in helping individuals bolster their performance.

However, Learning and Development professionals (L&D) are often asked this question 'Why should we keep learning?'

In those organizations that aren't populated by L&D professionals, those in the area of operations and finance are skeptical about the need for investing in learning and development and its value to their organizations.

This article provides 10 good answers you can provide to people who question the value of investing in continual training, learning and development.

  1. Training helps companies and individuals maintain a competitive advantage
  2. The Biotechnology industry is evolving. Competitive forces such as entry of new competitors, the threat of new substitutes, the bargaining power of buyers and suppliers, the rivalry among existing competitors are on the rise. To maintain competitive advantage companies are relying not only on corporate technology, patents, and strategic positioning but also on effective development and management of their workforce.

    Example:

    This webinar Supplier Qualification Audit, A Risk Based Approach discusses requirements for supplier and vendor qualifications. Attendees will learn how to develop a risk management plan for monitoring of suppliers, vendors and service providers. It will also discuss how to prevent recalls and advisory notices due to provided non-conforming materials or bad services.

  3. Training helps match up to the industry dynamics and its underwriting technologies
  4. The Biotechnology industry is highly dynamic. There are extraordinary shifts in technologies as well as its markets. A biotechnology employee approximately goes through 5-7 career shifts over their lifetime. To ensure that their skills are commensurate with the dynamics of the industry and its underwriting technologies, they should continually upgrade their skills throughout their career.

    Example:

    The webinar Understanding and Implementing a Technology Transfer Process discusses the steps to guide the technology transfer for the successful implementation, ensures that products of the highest quality are delivered to the patients along with meeting the business demands of the company.

  5. Training helps comply with regulatory requirements
  6. Regulatory agencies have the legal rights to conduct unannounced inspections if they deem there are suitable grounds for doing so. Therefore regulatory compliance training programs are required so that the organization can comply with the regulations, specifications and guidelines.

    Biotechnology companies must comply with FDA guidelines provided in the 21 CFR 211 for manufacturing, processing, packing, and handling of a biotech product. It requires organizations to document and implement standard operating procedures (SOPs) that detail guidance for key activities. It requires all employees and supervisors to be trained in accordance with his/her role to ensure the capability to perform the assigned activities.

    Examples:

  7. Training provides practical knowledge and enables learning from real-life scenarios
  8. Formal teaching of validation methodologies gains very little attention in undergraduate biochemistry and biotechnology courses. More and more biochemistry and biotechnology graduates are finding jobs in the field of industrial validation connected with biopharmaceutical, diagnostics, biomedical device, and pharmaceutical validation. Biotechnology companies need to seek training programs that impart an understanding of validation within the regulatory frameworks that they operate.

    Example:

    The validation essentials for medical device manufacturers webinar covers what processes needed to be validated and what steps you need to take to validate processes.

  9. Training protects the well-being of users
  10. Biotechnology companies that optimally train their employees safeguard and protect the well-being of users of the product.

    Example:

    The training program Guideline to Aseptic Technique and Clean Room Behavior discusses how, in sterile compounding, aseptic technique is contributing to the prevention of microbiological contamination. It provides sterility, safety, and efficacy to the sterile product, especially various injections for patients.

  11. Training helps prevent process and product variability
  12. Apart from simply imparting specific task-oriented knowledge, training helps generate quantifiable results. For instance, well-planned onboarding and sustainable training programs help in achieving an organization-wide culture of quality. On the other hand, inadequate training can lead to process and product variability.

    Example:

    In this course attendees will learn the fundamentals for reviewing batch records in a pharmaceuticals, biologics and medical devices environment.

  13. Trained professionals can inspire and teach others
  14. Professionals who have acquired knowledge and skills from training programs can pass on the information to others. By teaching others, the person who teaches gains mastery. It provides a sense of satisfaction. A great leader makes learning a part of the organization's culture.

    Example:

    The program 'How to make GMP training fun and engaging' will cover proven learning techniques for technical and compliance related training programs. It will answer key questions about how to make GMP training sessions more engaging and even fun for the learners in your organization.

  15. Training opens new opportunities
  16. For individuals, attending the biotechnology industry seminars helps to widen horizons and encourage self-development. With their new knowledge, they may be able to identify new opportunities for the organization, or find more effective ways of working. It can increase your their list of contacts, including potential customers.

    Example:

    ComplianceOnline's in-person seminars are a great way to interact and connect with industry professionals.

  17. Training provides proof of your organization's commitment to quality to regulatory agencies
  18. Many training programs provide credits of recertification. When employees gain such certifications. It lets the organization and employee demonstrate their commitment to being highly skilled and knowledgeable. Regulatory agencies look for credentials of commitment to be a highly skilled and knowledgeable regulatory organization.

    Example:

    This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics, Biosimilars, Orphan Drugs and Combination Products in Latin America.

  19. Training encourages commitment
  20. Retaining good employees is one of the biggest challenges in the Biotechnology industry. Training can give the learner a chance to take on higher responsibility or make him a stronger candidate for promotion. When employees see that organizations are committed to their development, the payback will likely their increased commitment to the employers.