Quality SOPs: Guidelines to developing and writing FDA Compliant Documents

Jan. 7, 2013 - PRLog -- learly written, detailed Standard Operating Procedures (SOPs) are one of the key indicators of the caliber of regulatory compliance enforced by an organization. SOP reviews are a high priority with auditors during an inspection. Poor quality, incomplete or non-existent SOPs are frequently a definite cause of a failed inspection.
Why Should you Attend:
This webinar will provide detailed guidelines on the specifics of compliant SOPs that are a key item in regulatory audits of companies. The SOP is reflective of the culture and commitment of a company to adhere to regulatory compliance. Poorly recorded SOPs could have dire consequences during an audit.

Objectives of the Presentation:
Poorly crafted and incomplete Standard Operating Procedures (SOPs) are the nemesis resulting in FDA 483 observations and Warning Letter citations. Implementing an organized SOP system will ensure that these deficiencies are eliminated. Adequate training and communication within an organization with all levels of personnel will enforce complaint documentation of procedural details necessary to generate accurate and reproducible results. Instilling the importance of accuracy and attention to detail during training sessions will be a motivator for personnel to adhere to approved SOPs while fulfilling their routine responsibilities that are impacted by regulatory compliance.

Who can Benefit:
Quality Assurance/ Quality Control Managers
Laboratory Technologists/ Analysts involved in Product Development
Senior Management (CEO, COO, Directors)
Regulatory Affairs professionals
GLP, cGMP and GCP Managers, Supervisors
Pre-clinical Laboratory Testing Personnel
Clinical Trial Professionals, IRB administrators