DUBLIN--(BUSINESS WIRE)--Research and Markets has announced the addition of the "5 Significant Training courses on 'SOP' Management" webinar to their offering.
SOP (Standard Operating Procedure), is used in a variety of different contexts, including healthcare, aviation, engineering, education, clinical research and many more. This webinar series will edify you in creation, management and implementation of adequate SOPs according to FDA criterions.
- 10 Steps to Perfect SOPs: FDA Compliance made easy
- Quality SOPs: Guidelines to developing and writing FDA Compliant Documents
- Writing and Enforcing Effective SOPs
- Critical SOPs for Clinical Sites
- Writing Effective SOP's
Who will benefit?
These webinar will be beneficial to the following:
- QA/QC/Compliance/Regulatory Professionals
- Senior Management Executives (CEO, COO, CFO, etc)
- Manufacturing/Project Managers, Supervisors and Personnel
- Clinical and Preclinical Laboratory Managers
- Clinical Research Associates and Supervisors
- Clinical Trial Specialists
- Project Managers
- Data Managers
- Principal Investigators
- Sponsors of INDs
- GLP, cGMP, GxP and GCP Managers, Supervisors
- Marketing & Sales
- Legal Counsel
Webinars included in the Package:
1. 10 Steps to Perfect SOPs: FDA Compliance made easy (Duration: 60 Minutes)
Formal and written Standard Operating Procedures (SOPs) are keystones of good operations. Almost every deficiency identified in FDA's 483s and Warning Letters can be traced back to deficiencies in SOPs at an organization. SOPs are often inadequate, miss important elements, do not contain important tools to increase compliance with the SOPs and, many times, are hard for the personnel who follow them to understand.
2. Quality SOPs: Guidelines to developing and writing FDA Compliant Documents (Duration: 75 Minutes)
Clearly 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.
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.
3. Writing and Enforcing Effective SOPs (Duration: 60 Minutes)
Writing SOPs or procedural documents can be challenging at times. However, writing SOPs is overall a straightforward process. However, enforcing what you already created and implemented in the pipeline is another story. The term SOP is very obvious. We have seen "clearly written description of how specific tasks are to be done."
4. Critical SOPs for Clinical Sites (Duration: 60 Minutes)
Clinical sites frequently struggle to understand FDA expectations regarding quality systems that should be in place to demonstrate compliance with good clinical practices. Experiences from FDA audits have shown that many clinical sites lack adequate systems and procedures for ensuring the good quality clinical trial conduct.
5. Writing Effective SOP's (Duration: 90 Minutes)
Virtually every FDA inspection includes a review of SOPs and adverse agency findings are often the result of SOP administration issues. This webinar will instruct the participant on how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow.
For more information visit http://www.researchandmarkets.com/research/9q7bn9/5_significant