2012 - Writing and Maintaining Quality Standard Operating Procedures (SOPs) to Guarantee FDA Compliance - Webinar By GlobalCompliancePanel

Overview: 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:
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
Who will 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
Price List:
Live : $245.00
Corporate live : $995.00
Recorded : $295.00
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http://www.globalcompliancepanel.com
Phone: 800-447-9407
Fax: 302-288-6884