SOPs for FDA-Regulated Industry: Best Practices to Withstand FDA Expectations: 2-Day In-Person Seminar by Ex-FDA Official

By: Peggy J. Berry, MBA, RAC, President & CEO, Synergy Consulting (Ex-FDA Official)
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Course “SOPs for FDA-Regulated Industry: Best Practices to Withstand FDA Expectations” has been pre-approved by RAPS as eligible for up to 10 credits towards a participant’s RAC recertification upon full completion.

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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

Who Will Benefit:

This workshop will be beneficial for individuals supporting clinical trials, manufacturing, distribution, marketing, regulatory affairs, compliance, quality control, and quality assurance:

  • Directors
  • Managers
  • Supervisors
  • Auditors
  • Regulatory operations
  • Clinical investigators, site management and contracting personnel
  • Clinical operations
  • Project managers
  • Data management
  • Medical writers
  • Compliance officers
  • Anyone required to create SOPs for their job function in a regulated industry

Course Outline

Day One (8:30 AM – 3:30 PM)
Registration Process: 8:30 AM – 9:00 AM
Session Start Time: 9:00 AM
  • 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 Two (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

Meet Your Instructor

Peggy J. Berry
Peggy J. Berry
MBA, RAC,President & CEO, Synergy Consulting (Ex-FDA Official)

Peggy J. Berry, MBA, RAC, is the President & CEO at Synergy Consulting where she provides consulting services to companies in all aspects of drug development. She also provides group and one-on-one training in drug development, regulatory affairs and project management topics. Prior to founding Synergy Consulting in 2015, she was Vice President of Regulatory Affairs at Insmed (2/2015-5/2015) where she was responsible for the development and implementation of global regulatory strategies and the management and oversight of the regulatory affairs department. Prior to Insmed, she was Vice President of Regulatory Affairs and Quality at Amarin (3/2009-2/2014). She has also held a variety of senior level positions at Dyax (5/2006-3/2009), MGI Pharma (now Eisai; 7/2005-5/2006), AstraZeneca (10/2001-7/2005), and Dey Pharma (now Mylan; 12/1997-10/2001). She has also held Regulatory Affairs roles within two clinical contract research organizations (ILEX Oncology and Cato Research Ltd; 1992-1997) and has worked in review divisions at the FDA (1985-1992). In addition, Ms. Berry consults for a number of companies in the regulatory and quality area, conducts a number of training courses, and is active in the Regulatory Affairs Professionals Society. She is the editor of the 2010 book "Choosing the Right Regulatory Career" (RAPS, MD) and author of the 2011 book "Communication & Negotiation" (RAPS, MD).

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