“Transform Your Training”-5 Top Tips for Implementing an Effective Training Program
Article By Vicki Pike, Operations Manager for EPiC Auditors
Training is essential in the pharmaceutical industry for several key reasons. Proper training helps maintain high standards of product quality and safety. Well-trained employees are better equipped to identify and prevent errors, ensuring that the products meet the required quality standards and are safe for patient use. Well-trained staff can perform their tasks more effectively, reducing waste and improving overall operational efficiency. Training also ensures that employees understand and adhere to GMP/GDP requirements, which is crucial for maintaining compliance.
The Eudralex GMP guide requires training for all personnel involved in production, storage, control labs, and other roles affecting product quality. This must include basic and role-specific training for new recruits, with ongoing training and periodic effectiveness assessments. Similarly, GDP mandates training for all personnel involved in wholesale distribution activities to ensure they are competent and experienced before starting their tasks. Training records must be kept, and effectiveness periodically assessed and documented.
Unfortunately, training deficiencies, such as overdue or incomplete training and failure to follow SOPs, have led to significant regulatory actions, including referrals to the MHRA Compliance Management Team (CMT) and Inspection Action Group (IAG). These issues are often part of broader systemic failures, which, although not cited directly as a training deficiency, inadequate training is a root cause or contributory factor.
During the EPiC Virtual Symposium on 28 November 2024, we held a round table discussion on GMDP training, including refresher training. Here are our top tips for implementing an Effective Training Program:
- Tailor Training to Roles: Develop training plans specific to each job role, considering responsibilities and required experience. Use job descriptions and SOPs to identify relevant tasks and ensure everyone receives appropriate GMP/GDP training during induction and on an ongoing basis.
- Effective Training Delivery: Choose the most effective training methods based on the role’s responsibilities. Options include:
- reading SOPs, when awareness of the activity is only required
- e-learning, can be used to pull out the key aspects of a procedure
- instructor-led training (classroom or virtual), to be used when a role has direct responsibility for an activity
- on-the-job training is best for practical demonstrations and coaching.
- Understand the ‘Why’: Ensure training materials explain not just what to do, but why it is done that way. Understanding the reasons behind tasks helps employees remember and comply with procedures and understand the implications of errors.
- Refresher training: Regular management reviews of the Quality System can identify adverse trends to plan topics for GMDP refresher training. Consider using real life examples of issues that have occurred at your own site for the basis of discussions and exercises, to make refresher training as relevant as possible to your teams. Also consider changes to regulations and new legislation. Stay informed about industry trends and inspection findings from MHRA, EMA, and FDA, and use resources like blogs, newsletters, free webinars, symposia, and forums.
- Interactive and Engaging Training: Make training interactive to promote engagement. For GMP/GDP refresher training, use a mix of shorter sessions throughout the year rather than one long annual session. Tailor training to the audience and include opportunities for questions and clarifications.
By following these top tips, companies can ensure their GMDP training is effective, relevant, and engaging, leading to better compliance and performance.
To assess the effectiveness of training, please see our previous post EPiC Top Tips – Assessing the Effectiveness of Training
Get in touch if you want to know more about how EPiC can deliver targeted, engaging training on a variety of topics.
Telephone: +44 (0)1244 980544 or email us at enquiries@epic-auditors.com