SOPs for FDA-Regulated Industry: Best Practices to Withstand FDA Expectations

Date Dec 13, 2018
Time (8:30 AM – 4:30 PM)
Cost 102750.00
Online
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.

Areas Covered in the Session :
  • 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 Should Attend :
This workshop will be beneficial for individuals supporting clinical trials, manufacturing, distribution, marketing, regulatory affairs, compliance, quality control, and quality assurance. Following personnel will benefit from the course:
  • Directors and VP’s
  • 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

 


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