Applying Global Standards to Life Sciences Compliance Documentation

Duration: 60 Minutes
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The documentation required by regulation - to include standard operating procedures and work instructions - is essential to the effective and compliant running of any regulated business. Unfortunately, many individuals in those businesses miss the valuable opportunities that properly developed Standard Operating Procedures/Work Instructions can provide. Regulated documentation can serve a variety of purposes other than meeting a regulatory requirement - as training materials, to standardize operations, to manage individual and group performance, to identify the sources of deviations, etc. The key is to know how to write those documents to properly meet those needs. Of late, there has been global guidance on how those documents should fit into the hierarchy of documents and how they should be structured to meet regulatory requirements. This webinar will address all of these areas.
SOPs and Work Instructions
Instructor: Charles H Paul
Product ID: 504874
Objectives of the Presentation
At the completion of this webinar, participants will be able to:
  • Discuss the importance of regulatory documentation
  • Discuss the value add applications of documentation to training, human performance, and the regulatory function
  • Explain and discuss what is wrong with documentation in our organizations
  • Define the importance of establishing a documentation hierarchy and building effective documentation templates
  • The new global hierarchy guidelines
  • Electronic common technical document specifications
Why Should you Attend
Writing effective Standard Operating Procedures and Work Instructions is not intuitive, it is not a skill that is often taught in our universities, and it can be a difficult and cumbersome task to execute. Knowing the most effective and efficient processes for gathering, organizing, formatting, and writing technical documentation is absolutely critical to providing significant value to a dreaded, avoided, and seemingly unimportant work task.

Areas Covered
  • The true purpose and function of regulatory documentation
  • What is the value add?
  • The pitfalls associated with writing regulated documentation
  • The documentation hierarchy
  • Documentation formats and specifications
  • Gathering the technical information you need
  • Using Subject Matter Experts
  • Documentation writing tips
  • Managing technical document reviews
Who will Benefit
  • Quality
  • Production
  • Regulatory
  • Compliance
  • Audit
  • Quality
  • R&D
  • Scientists
  • Documentation and Validation
  • Clinical Research
  • Lab Managers
  • Engineering and Manufacturing
  • Essentially everyone in the organization is tasked with creating regulatory documentation
$375
Recorded Session for one participant
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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:
Charles H. Paul is the President of C. H. Paul Consulting, Inc. - a regulatory, Lean Manufacturing, training, and technical documentation consulting firm. Charles is a management consultant, instructional designer and regulatory consultant and has led C. H. Paul Consulting, Inc. since its inception over 25 years ago. He regularly consults with Fortune 500 pharmaceutical, medical device, and biotechnology firms assisting them in achieving human resource, regulatory, and operational excellence. He is a regular presenter of webinars and on-site seminars in a variety of related subjects from documentation development to establishing compliant preventive maintenance systems. The firm works globally completing projects throughout the EU, UK, South America, and Asia.
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