FDA Compliant SOPs for Regulated Industry: Documents of Ideal Quality Management Systems
Date: March 13-14, 2025
Time: Starts at 10 AM EST
Duration: 2 Days
SOP deficiencies are one of the top 5 findings in FDA audits. The entire Quality Management System (QMS) of an organization could be severely compromised due to SOP defects. Formal written Standard Operating Procedures (SOPs) are required both by the FDA and EMA. Almost every deficiency identified in FDA’s 483s and Warning Letters can be traced back to deficiencies in SOPs at an organization. SOPs are often inadequate, miss important elements, do not contain important tools to increase compliance with the SOPs and, many times, are hard for the personnel who follow them to understand. They are frequently poorly written, communicated, monitored and enforced. This workshop will provide step by step instructions to create SOPs for FDA-regulated organizations.
Throughout the workshop, the author will discuss case studies and examples to highlight the common errors and potential solutions. Additionally, the logistics of creating, maintaining, scope, training and documentation will be reviewed. Pros and Cons of paper and electronic SOPs will also be discussed. This workshop contains a collection of practical tips from the trainer’s extensive FDA audit experience. Common questions regarding validation requirements, handling deviations, frequency of review and update, evaluating non-SOP driven processes, global SOPs, and ways to address FDA 483s regarding SOPs will be discussed using sample SOPs. This workshop is applicable to all FDA-regulated organizations: clinical trials, manufacturing, advertisement, marketing, regulatory affairs, auditing, and laboratory testing.
Throughout the workshop, the author will discuss case studies and examples to highlight the common errors and potential solutions. Additionally, the logistics of creating, maintaining, scope, training and documentation will be reviewed. Pros and Cons of paper and electronic SOPs will also be discussed. This workshop contains a collection of practical tips from the trainer’s extensive FDA audit experience. Common questions regarding validation requirements, handling deviations, frequency of review and update, evaluating non-SOP driven processes, global SOPs, and ways to address FDA 483s regarding SOPs will be discussed using sample SOPs. This workshop is applicable to all FDA-regulated organizations: clinical trials, manufacturing, advertisement, marketing, regulatory affairs, auditing, and laboratory testing.
Who Will Benefit:
- Directors
- Managers
- Supervisors, and lead workers in Regulatory Affairs
- Quality Assurance and Quality Control personnel
- Auditors
- Clinical investigators, site management and contracting personnel
- Clinical trial specialists
- Project managers
- People investing in FDA-regulated product development projects
Speaker: Mukesh Kumar
PhD, RAC | CEO, FDAMap
For more info, fill the box below. We will contact you within 24 hrs.
Day One (10:00 AM - 3:30 PM EST)
10:00 – 11:00 AM: Lecture 1: SOPs for a given organization: FDA Requirements
- 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
11:00 – 12:00 PM: Lecture 2: 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 PM – 12:30 PM: Break
12:30 – 2:15 PM: Lecture 3: 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
2:00 PM– 2:15 PM: Break
2:30 – 4:00 PM: Lecture 4: 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 (10:00 PM - 4.00 PM EST)
10:00 – 11:00 AM: Lecture 5: 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
11:00 – 12:00 PM: Lecture 6: Effective Writing Strategies
- Writing Exercise for SOP
- Style, tone, and content arrangement
- Best practices for SOP approval process
- Electronic verses paper SOPs
12:00 – 12:30 PM: Break
12:30 – 2:15 PM: Lecture 7: 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
2:00 PM– 2:15 PM: Break
2:30 – 4:00 PM: Lecture 8: 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
Register Online (By clicking on the links below)
Prices are in US Dollars.
The registration fee includes the workshop and all related course materials.
Terms & Conditions to register for the Workshop
Your Registration for the workshop is subject to following terms and conditions. If you need any clarification before registering for this seminar, please email us at info@fdamap.com
Payment:
We accept credit card, debit card, and PayPal.
Cancellations and Substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 20 working days prior to the start date of the event will receive a refund — less a $200 administration fee per person. No cancellations will be accepted — nor refunds issued — within 20 working days from the start date of the event.
On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($200) will be transferred to any future FDA Map event and a credit note will be issued.
