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

• 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

• 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

Peggy J. Berry, MBA, RAC, is the president and 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).