How to Write Perfect FDA-Compliant SOPs: Stepwise Instructions
Date: February 10, 2025
Duration: 60 Minutes
Time: 12 PM EST
This highly anticipated webinar provides a direct and comprehensive approach to addressing the issues surrounding SOPs. Led by an industry-leading expert with extensive experience in crafting and reviewing SOPs for hundreds of FDA-regulated organizations, it provides step-by-step instructions for creating and implementing effective SOPs. Through the use of case studies and examples, common errors and potential solutions will be highlighted. Additionally, the seminar will cover the logistics of creating, maintaining, scoping, training, and documenting SOPs. The pros and cons of paper and electronic SOPs will also be discussed.
The seminar draws upon the trainer’s wealth of knowledge gained from extensive FDA audit experience, offering practical tips to enhance your organization’s compliance. By addressing deficiencies in SOPs, you can avoid the pitfalls that often result in FDA 483s and Warning Letters. Join us in this seminar to ensure that your SOPs align with FDA compliance standards.
1. Evaluate Your Current SOPs: Gain the knowledge and tools to assess your existing SOPs for the most common issues identified by the FDA during audits. Identify gaps and areas for improvement, allowing you to proactively address compliance concerns.
2. Practical Tips and Tested Strategies: Acquire practical tips and tested strategies for creating, revising, updating, training, and documenting SOP processes within your organization. Unlock the secrets to creating robust, compliant SOPs that enhance operational efficiency.
3. Case Studies and Key Concepts: Our speaker will share enlightening case studies that illustrate core concepts and alternative approaches to compliance. You will walk away with a deep understanding of the least-burdensome approach to meeting FDA regulations effectively.
Don’t let deficiencies in your SOPs compromise your organization’s compliance efforts and FDA audit outcomes. Allow us to assist you in enhancing your SOPs, strengthening your quality management systems, and achieving seamless compliance.
- Essential elements of an SOP
- Process mapping techniques to define the contents of an SOP
- Role of personnel in creating SOPs
- SOP revisions, updates, creation, retirement and documentation
- Categorization of SOPs
- Assessment of compliance techniques
- Training practices for FDA compliance
- Access and access control to SOPs
- QA/QC/compliance/regulatory professionals
- Senior management executives (CEO, COO, CFO, etc)
- Manufacturing managers, supervisors and personnel
- Clinical and preclinical laboratory managers
- 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.
Webinar Fee
Prices are in US Dollars.
The registration fee includes: The live webinar & all related course materials.
Terms & Conditions to register for the Webinar
Your Registration for the workshop is subject to following terms and conditions. If you need any clarification before registering for this webinar please email us at info@fdamap.com
Payment
We accept credit card, debit card, and PayPal.
Cancellations & Substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 5 business days prior to the start date of the event will receive a refund — less a $30 administration fee. No cancellations will be accepted — nor refunds issued — within 5 business days before the start date of the event. You may however, choose to substitute the webinar for which you are registered with some other webinar in the future.
On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($30) will be transferred to any future FDA Map event and a credit note will be issued. No-shows will be charged the full amount.
Webinar material will be uploaded on the website 24 hours before the scheduled date of the webinar. In case it is not available on the website due to some technical issues, we will email the material a few hours before the start of the webinar.
In the event FDA Map cancels the webinar, FDA Map will issue a full refund to all the registrants for that webinar. Some topics and speakers may be subject to change without notice.
