Writing and Maintaining Quality Standard Operating Procedures (SOPs) to Guarantee FDA Compliance
A cogent understanding and thorough knowledge of the regulations for SOPs is a necessity for product development and clinical testing organizations with the goal of agency approval, and product commercialization.
Information flow should be elucidated in lucid, comprehensible steps that can be easily understood by all levels of personnel from inexperienced analysts to managers. Measures should be implemented to ensure that the personnel and the inspectors are allied with the understanding, interpretations the expectations for complaint SOPs.
Why should you attend: 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.
Areas Covered in the Session: This webinar will provide comprehensive guidelines for the best practice in the preparation and maintenance of SOPs. Detailed information will be provided on the following topics:
Who will benefit
- When an SOP is required
- Process to create an SOP
- A Standard SOP template; Header and Footer
- Defining a process map or flow chart to accompany the insertion of information.
- Content - (1) General SOP information, and (2) SOP specific for equipment, bio-analytical procedures, and clinical research.
- Ensuring that the content meets recommended regulatory guidelines
- The process for an approved SOP, author, reviewer, and approver.
- SOP deviations
- Strategies to ensure that personnel are following the SOPs
- Organizing, cataloging and archiving SOPs
- Personnel Training and documentation
- Access control of SOPs
- SOP revisions, updated versions and retirement
- FDA and EU requirements
- Examples: FDA Form 483s and Warning Letters
- 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