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Here are all the important info about Crafting Effective SOPs: Ensuring Compliance with Inspectors.
| Category: | Events |
| Event Category: | Webinar |
| Event Type: | Education and Training |
| Starting Date: | Dec 15, 2023 (Fri) |
| Last Date: | Dec 15, 2023 (Fri) |
| Event Status: | Expired |
| Organized By: | Skillpreceptor |
| Venue: | online |
| Event Add: | sheridan |
| City: | Sheridan |
| State: | Wyoming |
| Country: | United States |
| Event link: | https://skillpreceptor.com/training/486/standard-operating-procedures-a-writing-guide |
Crafting Effective SOPs: Ensuring Compliance with Inspectors
OVERVIEW
Attending this training will help the participants understand the specific requirements and expectations of FDA inspectors, allowing them to develop SOPs that meet regulatory standards and demonstrate compliance. Â By learning how to write SOPs that satisfy FDA inspectors, participants can proactively identify and address potential compliance gaps or issues. This training will provide them with the knowledge and skills necessary to develop robust and comprehensive SOPs, minimizing the risk of regulatory non-compliance and associated penalties.Â
Effective SOPs not only satisfy FDA inspectors but also contribute to improved operational efficiency and consistency within an organization. By attending this training, one will learn how to write SOPs that clearly outline procedures, roles, and responsibilities, promoting standardized processes and reducing variability in operations.
WHY SHOULD YOU ATTEND?
Formal and documented Standard Operating Procedures (SOPs) serve as the cornerstone for effective operational practices. Within the realm of FDA audits, it's noteworthy that SOP inadequacies rank among the top 5 findings. Furthermore, nearly every shortfall pinpointed in the FDA's 483s and Warning Letters can be linked back to an organization's deficient or non-existent SOPs.
LEARNING OBJECTIVES
Attend the webinar to know why written procedures and beneficial and understand the FDA expectations for regulatory requirements and written documents.
AREAS COVERED
- Understand the purpose and significance of Standard Operating Procedures (SOPs) in regulatory compliance.
- Learn the key components of effective SOPs.
- Gain insights into the structure and format of SOPs that satisfy inspectors and auditors.
- Explore best practices for writing clear and concise SOPs.
- Identify common mistakes to avoid when drafting SOPs.
- Enhance your ability to create SOPs that meet industry standards and regulatory requirements.
WHO WILL BENEFIT
The following professionals will benefit from this training:Â
- Managers
- Supervisors, and lead workers in Regulatory Affairs
- Quality Assurance and Quality Control personnel
- Quality systems specialists
- Document control specialists
- CAPA specialists and managers
- Regulatory and compliance specialists
- Internal auditors and managers
- Training specialists and managers
About speaker
Meredith Crabtree has over 25 years of experience in regulated industries, ranging from Blood, Plasma, Tissue, Laboratory, Pharma, Medical Devices, Cosmetics, Supplements, and Animal Health manufacturing and distribution. Meredith works as a Quality Consultant performing label reviews, 3rd party inspections, Consent Decree, and Recall support. She also performs regulatory assessments and Quality training. Meredith has a degree in Medical Technology and is currently obtaining a degree in Quality Systems.
FAQs about Event
Let's now talk about some of the most frequently asked questions about Event. These questions are based on need of users.
What is the starting date of the event?
Event will start from Dec 15, 2023.
What is the last date of the event?
Event will end on Dec 15, 2023.
What is the address of the event?
Sheridan.
What is the event website?
You can check out more info about the event at https://skillpreceptor.com/training/486/standard-operating-procedures-a-writing-guide.
Event organizing country?
United States.
State Name of the event organizer?
Wyoming.
City Name of the event organizer?
Sheridan.
What is the area pin code of the event?
Area pin code for the event is 82801 .
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