Effective SOP Development for Regulatory Compliance

Duration: 60 Minutes
Attend this webinar by expert speaker Danielle DeLucy, MS, to know how you can write, organize and maintain SOPs and also train your staff/personnel effectively to ensure reproducible and easy-to-follow compliance.
SOP Development
Instructor: Danielle DeLucy
Product ID: 501863
Governed by FDA and world health authorities, (SOPs) are industry regulatory requirements. When used in combination with planned training and regular performance feedback, SOPs facilitate an effective and motivated workforce. It is obvious that most people want to do a good job. A manager is successful when he/she can channelize the efforts of workers towards positive business development. If the SOPs are written well enough, they tend to improve communication, provide direction and improve consistency at work. Developing the SOP process is a good way for managers/technical advisers and workers to cooperate for everyone’s benefit.

Objectives of the Presentation
You will learn how you can develop an effective review and approval process which will be compliant with regulatory requirements. Also, know how to implement a training program for document review and creation. In addition, learn how to format SOPs and provide a system for control, archival and disposal of written procedures.

Why should you Attend
Currently, no guidance is available on how to manage or develop the SOP creation or quality system. This leads to SOPs written so complicated and erroneous that compliance becomes difficult and sometimes impossible. Many cases have led to production of subpar documents which have come to light during a regulatory inspection.

Attend the webinar to know why written procedures and beneficial and understand the FDA expectations for regulatory requirements and written documents.

Areas Covered
  • Why written procedures are beneficial
  • FDA expectations for written documents and regulatory requirements
  • Developing an effective review and approval process compliant with regulatory requirements
  • How to implement a training program for document creation and review
  • A system for the control, archival, and disposal of written procedures
  • Formatting SOPs
  • Elements to include other than the procedure
  • How to write effective but efficient documents
  • Roles and responsibilities of authors and reviewers of SOPs
  • How to define roles in SOPs for supervisors and operators
Who will Benefit
  • Directors, Managers
  • Professionals
  • Technical writers and General staff with the responsibility for creating, reviewing and approving written standard operating procedures and instructions
$375
Recorded Session for one participant
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Live Session - How it works
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  • 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
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  • 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:
Danielle DeLucy, MS, is owner of ASA Training and Consulting, LLC which provides Pharmaceutical and Biologics based companies with training and quality systems assistance in order to meet Regulatory compliance. Prior to this role, Danielle has been in the industry for 15 years serving in numerous Quality Management Roles, such as the Director of Product Quality, the oversight of Sterility Assurance practices and provided QA oversight of numerous filling and packaging operations. Danielle began her QA career as a Quality Control Pharmaceutical Microbiologist at a contract laboratory where she performed various tests for their clients. In the years after, she has held positions in the Quality management arena while increasing her responsibility. She has helped to lead many Regulatory Health Inspections and was instrumental in the coaching process of her peers prior to any inspection. Currently, Danielle assists companies who are faced with warning letters, consent decrees and those wishing to improve compliance establish more robust quality systems so that the company can succeed.
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