Description
OVERVIEW
Appropriate Standard Operating Procedures are vital to the implementation of many of the operations in the Pharmaceutical and Medical Device industries. They must manage many of the things that assure compliance to the relevant regulations and business practices.
The SOPs are also related to standards practices such as ISO 9000, Quality Management, and Risk Management.
WHY SHOULD YOU ATTEND
Most of the work done in the Pharmaceutical and Medical Device industries is regulated and therefore follows well defined processes. These processes are managed with Standard Operating Procedures that manage most of what is done.
These procedures are written as clear, well-defined steps, 1, 2, 3, , , that can be followed without introducing errors or other problems.
These SOPs have to managed, updated, reviewed, changed, and continually monitored.
The SOPs will describe what is to be done by whom and what products are to be produced. It will describe how to determine the adequacy and content of these products.
AREAS COVERED
- Preparation of SOPs
- Usage of SOPs
- Documentation of Relevant Processes
- Quality Records
- SOP Training
LEARNING OBJECTIVES
Managing SOPs is a continuous process. There are changes that are happening a lot of the time today. Changes in regulations and changes in technology must continuously be monitored and reacted to. Change is an area where the regulatory agencies tend to watch.
WHO WILL BENEFIT
- SMEs doing the work
- Quality assurance
- Regulatory Professionals
- Biostatistics
- Data Management
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