Management of Standard Operating Procedures

Product Id : FDA161
Instructor : Richard Chamberlain
Oct 24, 2018 1:00 PM ET | 12:00 PM CT | 10:00 AM PT | 90 Minutes

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Description

Appropriate Standard Operating Procedures are vital to the implementation of many of the operations in the Pharmaceutical and Medical Device industries. They must manage many of the things that assure compliance to the relevant regulations and business practices.

The SOPs are also related to standards practices such as ISO 9000, Quality Management, and Risk Management.

Why Should You Attend:

Most of the work done in the Pharmaceutical and Medical Device industries is regulated and therefore follows well defined processes. These processes are managed with Standard Operating Procedures that manage most of what is done.

These procedures are written as clear, well-defined steps, 1, 2, 3, , ,  that can be followed without introducing errors or other problems.These SOPs have to managed, updated, reviewed, changed, and continually monitored.

The SOPs will describe what is to be done by whom and what products are to be produced. It will describe how to determine the adequacy and content of these products.

Areas Covered in the Session:

  • 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

Who will benefit:

  • Quality assurance
  • Regulatory Professionals
  • Bio-statistics
  • Data Management
  • Production Persons
Speaker Profile:

Richard Chamberlain has a Ph.D. in Statistics and has consulted with numerous Pharmaceutical, Contract Research Organizations, and Medical Device companies in the areas of Computer Systems Validation, Data Management, computerized project scheduling, strategic planning, and Quality Management.

He has assisted with the development of all varieties of Standard Operating Procedures and other required documentation for Quality Management and Compliance to Regulations.


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