Introducing GMP Training
The Introducing GMP Training Course is a foundation or refresher course useful for individuals who need to understand what Good Manufacturing Practice (GMP) means for healthcare manufacturers, and subsequently their suppliers.
The course takes into consideration how GMP is applied throughout companies, by viewing the organisation using the categories: People, Procedures and Documentation, Products and Components, and Production Areas and Equipment.
Other key parts of the course include a review of the industry regulators, their requirements and how they regulate. Also investigated are the consequences of non-compliance, and people behaviours and habits, to encourage GMP in operations.
The course attracts a mix of learners from different industries and mixed disciplines, including pharmaceutical and medical device manufacturers, wholesale distributors, and suppliers including OEMs.
GMP Fast Track Freshers Training Programme
The GMP Fast Track Freshers Training Programme is a useful training course for individuals either new to a healthcare manufacturing company or moving departments, to learn and understand more about Good Manufacturing Practice (GMP) and its application.
The first day of the programme is the Introducing GMP Training (1 Day) Course, building an understanding of GMP and its application.
The second day progresses to investigate electronic records and signature requirements for America and the EU. Important consideration is given in the use of best practice SOPs, and corresponding training and evaluation. An overview of the validation process and how it is implemented is described and explained.
The course enables learners to investigate the regulatory drive for implementing risk management (review of Q9 Guidance), including the FMEA risk assessment method and the importance of change control including related issues. Learners also apply their learning by reviewing real case studies where GMP non-compliance could occur, determining potential solutions to such situations.
GMP Refresher Training
The purpose of the GMP Refresher Training (1 Day) course is to provide individuals with an update and heighten the importance of following GMP in their day-to-day activities.
It is all too easy to slip into bad habits and practices, and interaction, activities and case studies focus on how to prevent errors occurring in the first place.
Current regulatory trends and innovation are investigated and reviewed, with people being encouraged to commit to improving GMP in their own sphere of operations.
Usually people working directly in manufacturing are best placed to attend this course.
GMP Training for Operators
The GMP Training for Operators is a useful course for packaging and manufacturing organisations, both for new staff or those requiring a refresher.
The course is designed to minimise the operators’ time away from the workplace. Within the half day course, the important basics are covered through interaction and operator involvement.
This course can be delivered on-site for maximum benefit, providing the option of covering two sets of operators over one day. The training is also available as an open course delivered in hotels.
GMP Training for Supervisors
Front line supervisors have a crucial part to play in ensuring their teams work to Good Manufacturing Practice (GMP), yet it can be a challenging role trying to ensure documentation is completed correctly, SOPs are followed, KPIs are updated and quality is upheld. And that’s without the people issues!
The GMP Training for Supervisors course provides new or established supervisors with the chance to explore people issues that could have a detrimental effect on product quality, through the use of interactive case studies. Consequently, solutions to the problems are determined and discussed by the group.
The learners also revisit the basics of GMP and review regulatory and business implications associated with GMP non-compliance.
Good Distribution Practice (GDP) Training Course
Are you trying to interpret and understand more precisely what good distribution practice means?
It could be that you’re new to the company or role. You could work for a supplier and want to learn and appreciate what good distribution practice means for you and your customers.
The Good Distribution Practice (GDP) training is a foundation or refresher course useful for individuals who need to understand what GDP means for the pharmaceutical manufacturer and subsequently their suppliers.
Organisations who store or transport pharmaceutical products need to understand and comply with GDP to ensure the safety and efficacy of pharmaceutical products throughout their shelf life and demonstrate commitment in providing a quality service for the delivery of pharmaceutical products in an ever increasing complex supply chain.
Tailored GMP Training
ITS can design your GMP training courses to meet the particular GMP requirements of your site. We can also deliver onsite for maximum benefit, providing the options of covering different sets of learners over a number of weeks precisely to your requirements.
ITS can visit your site to view your operations and talk to key stakeholders to gain an accurate understanding of your company’s key GMP challenges. The training can then be developed around the improvement areas.
ITS’ Regulatory Compliance Training Manager Elizabeth Vaughan who has over 30 years’ experience working in the pharmaceutical industry and five years delivering work-based training solutions for industry clients in healthcare industries including pharmaceutical and medical devices will work with you to identify your training requirements.
We can include how GMP translates into product quality through manufacturing processes, the importance of a healthcare company’s Quality Management System and understand GMP in terms of principles categorised as People, Procedures, Products and Production Areas. We can also emphasise aspects of human input in manufacturing operations to promote greater appreciation of the importance of each person’s contribution to successful good manufacturing practice in their particular product operations.
The training content can also fulfil your requirements for annual refresher training and use a number of interactive techniques including games and group activities to increase learner engagement.
If you think this could be useful please do not hesitate to contact us regarding your future requirements.
Introducing GMP, Root Cause Analysis and Understanding Validation Training Programme
The purpose of the Introducing GMP, Root Cause Analysis and Understanding Validation (3 Day) Training Programme is to provide learners with the opportunity of either taking one course alone, a mix of the following courses or all three in their entirety, over consecutive days.