One of the best ways to ensure that an organization meets its regulatory obligations is to follow SOPs. SOPs are standardized procedures and processes prepared with enough detail to ensure that tasks are performed consistently each time they are done. SOPs are also required to be in compliance with regulations and guidelines internationally, across all regulated functions. Lack of SOPs and not following SOPs are often cited in regulatory inspections as deficiencies that must be corrected. Poorly prepared SOPs or poor compliance with existing SOPs can compromise a drug development program, an effective quality system, and may result in product recalls.
This workshop will explore what SOPs are, what they are used for, when they are required, how to write them effectively for compliance and for implementation within the organization, and how to ensure effective communication and training of procedures within the SOPs.
Learning Objectives:
- Regulatory requirements for SOPs
- Legal requirements for SOP creation and maintenance
- Types of SOPs
- Formats and essential components of SOPs
- How to effectively write an SOP to ensure compliance
- SOP training and implementation
- Deviations from and changes to SOPs
Who Will Benefit:
This workshop will be beneficial for individuals supporting clinical trials, manufacturing, distribution, marketing, regulatory affairs, compliance, quality control, and quality assurance:
- Directors
- Managers
- Supervisors
- Auditors
- Regulatory operations
- Clinical investigators, site management and contracting personnel
- Clinical operations
- Project managers
- Data management
- Medical writers
- Compliance officers
- Anyone required to create SOPs for their job function in a regulated industry