Creating Effective SOPs for Regulatory Compliance

Duration: 90 Minutes
This webinar will discuss developing procedures for meeting quality and compliance requirements; Standard Operating Procedure development and maintenance; Standard Operating Procedures for step-by-step activities; measure quality and demonstrate compliance to regulatory and other business requirements and produce Quality Records.
Creating Effective SOP
Product ID: 501034

During the last several years, the FDA has increased its emphasis on quality. At the same time new technologies are changing the way many things are done in the Pharmaceutical, Medical Device, and other industries. This has increased the importance and use of written procedures for much of the work that is done today.

Areas Covered
  • The role of SOPs in quality management
  • The role of SOPs in regulatory compliance
  • The role of SOPs in project management
  • The organization of processes that require SOPs
  • How to prepare necessary SOPs. What they should contain and what they should not contain
  • The content and format of SOPs
  • The responsibilities of the various Stakeholders

Why Should you Attend
This course will put you in a position to better comply with the required regulations and quality requirements. It will also make it possible to demonstrate that compliance.

Objectives of the Presentation
  • How to organize the processes and procedures
  • How to develop SOPs that can be managed
  • The development of training modules to support the SOPs
  • The production of "Products" that provide Quality Records and demonstrate compliance
  • How to apply Change Control to SOPs
  • Who are and what are the roles of the various Stakeholders?
Who can Benefit
  • Quality Assurance Staff
  • Auditors
  • Subject Managers
  • IT Staff
  • Regulatory Affairs
$375
Recorded Session for one participant
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  $500.00 Training CD
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How it works
Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Richard Chamberlain's experience includes consulting with numerous Pharmaceutical, Contract Research Organizations, and Medical Device companies in the areas of computerized project scheduling, strategic planning, Quality Management and Computer Systems Validation. He has also managed large-scale clinical projects including development of Remote Data Entry systems, Adverse Event reporting, Drug Supplies, project planning and supervision of staffs.

Apart from these Mr Chamberlain has taught numerous public and in-house courses on various aspects of Computer Systems Validation and Auditing Computer Systems; assisted in the development and validation of numerous computerized systems in all GxP environments; assisted with the development of all varieties of Standard Operating Procedures and other required documentation for Quality Management and Compliance to Regulations. He is also familiar with the various aspects of Computerized Systems and CFR 21, Part 11, FDA Guidelines for Computers, ICH-GCP, and GxPs.
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