The development of Pharmaceutical Products typically takes years and costs significant amounts of money.
Pressures to get products to the market are ever increasing so working in a well- controlled, compliant manner during all phases of development is essential if market approval of a product is to be achieved. Although there is some guidance available, often those involved are unsure of how much “GMP” is required and when it is required. Once Investigational Medicinal Product (IMP) manufacture has been initiated, it becomes a little easier, however there are still some flexibilities allowed depending on the phase of the clinical trials involved. There is therefore a need for some practical GMP guidance for these important stages of the product lifecycle and sharing of experiences.
The course is suitable for any person working in QA or QC plus Formulation Scientists and Regulatory Affairs personnel plus those looking after the premises, utilities and equipment. In addition, those starting out working in this field and those who even if they have worked in this field for some time, have little or no understanding of the GMP expectations for these activities. It could also be of benefit for trainee QPs who do not work in this field and have little understanding of the challenges involved.
Pressures to get products to the market are ever increasing so working in a well- controlled, compliant manner during all phases of development is essential if market approval of a product is to be achieved. Although there is some guidance available, often those involved are unsure of how much “GMP” is required and when it is required. Once Investigational Medicinal Product (IMP) manufacture has been initiated, it becomes a little easier, however there are still some flexibilities allowed depending on the phase of the clinical trials involved. There is therefore a need for some practical GMP guidance for these important stages of the product lifecycle and sharing of experiences.
The course is suitable for any person working in QA or QC plus Formulation Scientists and Regulatory Affairs personnel plus those looking after the premises, utilities and equipment. In addition, those starting out working in this field and those who even if they have worked in this field for some time, have little or no understanding of the GMP expectations for these activities. It could also be of benefit for trainee QPs who do not work in this field and have little understanding of the challenges involved.
