Designing an Effective and Compliant Standard Operating Procedure (SOP) and Standard Test Method (STM)

Why Should You Attend:

Designing an effective Standard Operating Procedure (SOP) and Standard Test Method (STM) is the pre-requisite to complying with the regulations guiding the manufacturing and testing of products. FDA inspectional form 483 inspectional findings relates to inadequate personnel training as well as personnel not following written SOPs/STMs. Poorly written and planned standard operating procedures (SOP) and Test Methods containing vague, incomplete or ineffective instructions is open to incorrect interpretations by personnel. There have been conflicts between written procedures when compared with internal and external policies and regulations due to poor or inadequate planning of the process for writing SOPs and STMs. Organizational and management issues relating to document review, verification, approval and training of personnel has led to issues affecting the manufacture of products. The non-involvement of other impacted departments during the planning, review, processing and approval of the SOP or STM creates costly mistakes to manufacturers of drug products. Understanding how to design, develop, process, review and apply the use of a well written SOP or STM will reduce the number of deviations, false out of specification results, failure investigations and non-conformances associated with the manufacture of products.

This 90-minute training will benefit manufacturers of manufactured products to achieve an effective, robust and compliant SOP and STM which will result in a cost effective and efficient manufacturing and testing of products. A well planned and written SOP or STM will reduce the incidence of out-of-specification (OOS) results, failure, product non-conformances, deviation and invalid assay investigations.

The attendee will gain a better understanding of 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.

Learning Objectives:

This webinar will provide the attendee the ability to:

1. Understand a Standard Operating Procedure (SOP) and Standard Test Method (STM), its application and regulatory requirements.
2. A Step by step process of how to develop, design, plan, draft, process, approve and maintain an effective and compliant SOP and STM.
3. Understand the process of checking for/preventing conflicts between the draft SOP or STM and other internal or external procedures, company quality manuals/policies and regulatory documents.
4. Reduce the number of Deviations, False Out-of-Specification (OOS) and Invalid Assay results that emanate from inadequate personnel training and compliance which may potentially impact the manufactured product or testing process.
5. Understand the role of an SOP or STM, impact of an ineffective and non-compliant SOP or STM on the manufactured product.
6. Understand the benefits of adequate planning, development and life cycle process of an SOP/STM in achieving compliance while reducing redundancies and increasing efficiencies.

Areas Covered in the Webinar:

Module 1:

1. Types of Operating Procedures or Test Methods
2. Industry Applications and Regulations Guiding Standard Operating Procedure (SOP) and Standard Test Methods (STM)
3. Importance of Standard Operating Procedures (SOP) and a Standard Test Methods (STM)
4. Considerations when Designing or Planning to Draft an SOP or STM
1. Impact on Internal or External Documents or Policies

Module 2:

1. How to Effectively Structure an SOP or STM
1. Benefits of a Structured SOP or STM
2. Role of SOPs and STMs in the Standardization of Activities and Testing Methodologies
3. Creation of Compatibility and Consistency
4. SOP and STM as a Training and Reference Document
5. Systems Analysis and Feedback
6. External Communications
7. Importance as a Compliance Tool
2. How to Interface and SOP or STM with Other Related Documents or Policies
1. Rationale for Considering Interfacing with Other Related Documents or Policies
2. What needs to be considered when planning or designing an SOP or STM
3. How the Detailed Content of an Effective SOP or STM Should Look Like
1. What needs to be Considered during an SOP/STM Organization and Processing
2. Target Audience, what to consider, allowing flexibility and removing ambiguity

Module 3:

1. Signs of an Ineffective SOP or STM
1. Reasons for Failed SOPs/STMs
2. SOP or STM Planning Process and Life Cycle
1. Performing Procedural Needs Assessment
3. SOP or STM Management and Life Cycle
1. The four (4) basic steps of an SOP or STM management and Life Cycle
4. Formatting the SOP/STM
1. How the format should look like
5. Reviewing and Approving the SOP or STM
1. The eight (8) basic steps of developing an effective SOP or STM

Who Will Benefit:

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
• Engineering
• Vendors/Suppliers
• All Technical Writers and SOP/STM Users
• Regulatory Affairs
• All levels of management

Charity Ogunsanya
Director of Quality Control, Pharmabiodevice Consulting LLC

Charity Ogunsanya has more than 23 years of extensive experience within the Biologics, Pharmaceuticals, Radiopharmaceuticals, Biotechnology and Medical Device Industries and has been the Microbiology, Sterility Assurance, Contamination Control, Aseptic processing, Quality Control Subject Matter Expert (SME) for multiple fortune 100 companies. She has a Bachelor of Science degree in Microbiology from the University of Benin-Nigeria and is currently in the Advanced Academic Master’s Biotechnology Program at the Johns Hopkins University with concentration in Biotechnology/Biodefense. She is the CEO/Owner of her consulting firm named Pharmabiodevice Consulting LLC. Her consultancy provides support to Biologics, Pharmaceuticals, Radiopharmaceuticals, Biotechnology and Medical Device Industries.

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