COURSE ID 2864

Standard Operating Procedure (SOP) and Standard Test Method (STM) Requirements

Designing, Development, Drafting, Processing and Approval of An Effective and Compliant SOP or STM

AVAILABLE ON-DEMAND
Duration: 90 Minutes
Course Instructor

Charity Ogunsanya

Price
$ 195
Discounts: We offer a 10% group discount when you register 2 or more attendees (up to 10). Contact us for groups over 10.

Course description

View Course Outline

Designing an effective Standard Operating Procedure (SOP) and Standard Test Method (STM) is the pre-requisite to complying with the different regulations guiding the manufacturing and testing of products. A well-established procedure and test method improves the numbers of manufacturing, testing and personnel deviations which indirectly affects the quality and life cycle process of a manufactured product.

This ON DEMAND accredited training course will provide the attendee the ability to understand the sequence of designing, development, drafting, processing and approval of an effective and compliant SOP or STM. The industry applications, regulations, content, organization, development, management process/cycle, content and formatting of an SOP and STM will be discussed. Understanding these requirements will aid in the reduction of manufacturing and testing errors arising from an unclear, poorly planned/executed and vague procedures that are left to several varying interpretations and applications which may sometimes lead to non-compliance.

Upon completion of this course, you will be able to:

  • Describe the application and regulatory requirements of a well-designed Standard Operating Procedure (SOP) or Standard Test Method (STM)
  • Develop, design, plan, draft, process, approve and maintain an effective and compliant SOP or STM
  • Prevent internal and external procedural conflicts when drafting a new SOP or STM
  • Reduce the number of personnel, procedural and test method deviations emanating from a poorly drafted SOP or STM
  • Appreciate the role and impact of a well-designed SOP or STM during the manufacture and testing of a cGMP product
  • List the benefits of adequate planning, development, and life cycle process of an SOP/STM in achieving compliance while improving efficiency
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This webinar will provide a great resource to Pharmaceutical, Biotechnology, Biologics, Drugs, Medical Device, In-vitro Diagnostics Industry personnel within the following functions:

  • Quality Control
  • Quality Assurance
  • Microbiologist
  • Chemist
  • Analysts
  • Manufacturing
  • Validation
  • Facilities
  • Materials
  • Engineering
  • Vendors/Suppliers
  • All Technical Writers and SOP/STM Users
  • Regulatory Affairs
  • All levels of management

Course Instructor

Ogunsanya_Charity

Charity Ogunsanya

Owner/CEO, Pharmabiodevice Consulting LLC

Charity Ogunsanya’s Courses

Accreditation

Team Training

When you need on-site attention, we’re not just here to help, we’re there to help—right by your side.

Individual courses are remarkably effective. But sometimes when you have a specific need, it helps to have expert guidance right in the room with you and your team.

In that case, we’re happy to design a custom training for your entire team, whether online—or on-site.

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