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Systematic Operating Procedures (SOPs) – What’s Really Required  

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Seminar Summary:

Learn the required components and elements of SOPs for FDA regulated industries and meet the FDA compliance and SOP expectations. (see full course description)

 

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Training Course Syllabus:


One of the best ways to ensure that an organization meets its regulatory obligations is to follow SOPs. SOPs are standardized procedures and processes prepared with enough detail to ensure that tasks are performed consistently each time they are done. SOPs are also required to be in compliance with regulations and guidelines internationally, across all regulated functions. Lack of SOPs and not following SOPs are often cited in regulatory inspections as deficiencies that must be corrected. Poorly prepared SOPs or poor compliance with existing SOPs can compromise a drug development program, an effective quality system, and may result in product recalls.
This workshop will explore what SOPs are, what they are used for, when they are required, how to write them effectively for compliance and for implementation within the organization, and how to ensure effective communication and training of procedures within the SOPs.

Learning Objectives:

Regulatory requirements for SOPs
Legal requirements for SOP creation and maintenance
Types of SOPs
Formats and essential components of SOPs
How to effectively write an SOP to ensure compliance
SOP training and implementation
Deviations from and changes to SOPs

DAY 01(8:30 AM - 3:30 PM)

08.30 AM - 09.00 AM: Registration
09.00 AM: Session Start
9:00 – 10:00 – Overview of SOPs
Purpose
Determining need for SOP vs. working practices; standards; policies
Regulatory and legal requirements for development of SOPs
Processes that do not require SOPs
10:00 – 10:15 – Break
10:15 – 12:00 – SOP structure and creation
The foundational SOP template
SOP numbering system
Determining appropriate sections and content requirements
Determining level of detail
Developing a review and approval process
Developing a deviation process
Developing a change control process
Establishing timelines
12:00 – 12:45 – Lunch
12:45 – 2:15 – What SOPs need to be created
Preparing a list of SOPs by function
Resources for regulatory required SOPs
How to determine additional SOPs that will be required
2:15 – 2:30 – Break
2:30 – 3:30 - Writing an SOP
Essential Components of an SOP
Standardized definitions
Attaching references and template forms
Level of details to include: responsible person, function, task-by-task specificity for consistency
Documentation of task completion & compliance with SOP: Checklists, forms, reports
3:30 – 4:30 – Review of Inspection-cited deficiencies
Review inspection findings by regulatory agencies regarding SOP deficiencies
Discuss best practices and pitfalls to avoid deficiencies

DAY 02(8:30 AM - 3:30 PM)

8:30 – 10:00 – Standard SOPs required for Key Drug Development Processes
Manufacturing
Clinical
Non-clinical
Regulatory
Compliance
Quality Assurance
10:00 – 10:15 - Break
10:15 – 12:00 – Outsourcing activities
SOPs required Internally to manage outsourcing
SOPs required for outsourced activities and verifying their acceptability
Availability of SOPs for review and reference
Changes to external SOPs and ongoing assessment
12:00 – 12:45 – Lunch
12:45 – 2:15 – Preparing the SOP
Using a process map to determine content and specificity for the organization
Standardizing style and tone
SOP control, distribution, obsoleting, revising
Prepare a sample SOP using an example provided
2:15 – 2:30 – Break
2:30 – 3:30 – SOP Communication and Training
Type of training for each SOP
Documentation of training
Conducting periodic reviews
Ongoing training requirements for updates and refreshers
Actions to take when SOPs are not followed: lack of training, deviations
3:30 – 4:30 – Preparing for Audits and Inspections
Coordinating audits
Providing SOPs for review
Addressing inspectional findings

Seminar Summary:

Learn the required components and elements of SOPs for FDA regulated industries and meet the FDA compliance and SOP expectations. (see full course description)

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