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SOPs for FDA-Regulated Industry: Best Practices to Withstand FDA Expectations  

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Seminar Summary:

This two day In-person seminar will provide step by step instructions to create SOPs for FDA-regulated organizations. (see full course description)

 

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Training Course Syllabus:


SOPs for FDA-Regulated Industry: Best Practices to Withstand FDA Expectations - FDA Regulation Training Seminar

Course Description:

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
SOPs for FDA-Regulated Industry: Best Practices to Withstand FDA Expectations Course Outline:

Day One(8:30 AM – 4:00 PM)

Registration Process – 8:30 AM – 9:00 AM

Session Start Time – 9:00 AM

9:00 – 10:00 AM: SOPs for a given organization: FDA Requirements
US and EU Regulations describing SOPs
Regulatory requirements for different organizations: sites, manufactures, labs
Requirements for various products: Drugs, biologics, devices, diagnostics, clinical labs
What processes do not need written SOPs
SOPs verses working practices and draft scripts
Legal requirements for creating and maintaining SOPs

10:00 – 10:15 AM: Break

10:15 – 12:00 Noon: Where to Start: Developing a Strategy
Listing tasks for a given organization
Qualifications of writing leaders and teams
Resource allocation and time-lines
Policies and procedures
Using Templates: Self-created and acquired

12:00 – 12:45 PM: Lunch

12:45 – 2:15 PM: How to Get Started
List of SOPs for different organizations: Clinical sites, manufacturing facilities, labs, etc
Process development and developing SOP on SOPs
Prioritizing tasks
Minimum requirements for SOPs
Risk-based approach for SOPs
Types of SOPs

2:15 – 2:30 PM: Break

2:30 – 3:30 PM: Writing an SOP: 5 Steps to a Good SOP
Format for an SOP
Essential Components of an SOP
Task split, distribution, and attribution
Documentation: Checklist, forms, and reports
Annotations


Day Two(8:30 AM – 3:30 PM)

8:30 – 10:00 AM: Essentials of a SOP Driven Process
What is Process Mapping and how can it be best used?
Categorization and organization of SOPs
Rules for electronic SOPs in the cGMP, GLP and GCP environment
Maintaining SOPs
Best practices for access control and distribution
Archiving, retiring, and audit trails for SOPs

10:00 – 10:15 AM: Break

10:15 – 12:00 Noon: Effective Writing Strategies
Writing Exercise for SOP
Style, tone, and content arrangement
Best practices for SOP approval process
Electronic verses paper SOPs

12:00 – 12:45 PM: Lunch

12:45 – 2:15 PM: Education and Training on an SOP
Best practices for training and documenting
Periodic reviews
Tools for SOP tracking and training validation
Train the trainer programs
Adapting Generic, Institution, or Sponsor SOPs for your Needs
SOP updates
Dealing with deviations

2:15 – 2:30 PM: Break

2:30 – 3:30 PM: Getting Ready for FDA Audits of SOPs
Common FDA 483s and Warning Letters regarding SOPs
Logistics of an FDA audit
Best practices for coordinating FDA review of SOPs
Addressing FDA findings
Responding to an FDA 483
Dos and Don’ts of an FDA audit

Seminar Summary:

This two day In-person seminar will provide step by step instructions to create SOPs for FDA-regulated organizations. (see full course description)

print this agenda print agenda for the SOPs for FDA-Regulated Industry: Best Practices to Withstand FDA Expectations training seminar

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