2-Day Virtual Bootcamp on Writing and Implementing SOP in Laboratory for FDA, EPA, and OSHA Compliance
Learn To Craft Procedures That Mitigate Risks And Enhance Repeatability Across All Lab Activities!
Instructor :
John Fetzer
Webinar ID:
10890
Date: JAN 01 (WED) - JAN 02 (THU), 2025
Start Time: 9 AM PT - 1 PM PT each day
Duration: 8 Hrs.
What you will learn
-
- Understand SOP Roles, Intentions, And Required Tasks.
- Explore Network Support And Structure/Format Of SOPs.
- Learn Compliance Requirements And Role Responsibilities Within SOP Processes.
- Review Various Standard Methods: Regulatory, Literature, And Industrial.
- Assess And Convert Standard Methods Into Usable SOPs.
- Create SOPs For New Tasks, Methodologies, And
-
- Understand SOP Roles, Intentions, And Required Tasks.
- Explore Network Support And Structure/Format Of SOPs.
- Learn Compliance Requirements And Role Responsibilities Within SOP Processes.
- Review Various Standard Methods: Regulatory, Literature, And Industrial.
- Assess And Convert Standard Methods Into Usable SOPs.
- Create SOPs For New Tasks, Methodologies, And Standard Methods.
- Improve Draft SOPs Through Lab Interplay And Compliance Assessment.
- Implement SOPs With Initial Training And Ongoing Proficiency Tests.
- Monitor, Update, And Revise SOPs As Needed With Documentation.
- Manage SOP Archiving, Documentation, And Compliance Requirements Effectively.
Course Description
Standard Operating Procedures (SOPs) are the backbone of laboratory efficiency and compliance.
Standard operation procedures being the centre of attention for FDA, EPA, and OSHA – you need to implement the right practices in your laboratory. This seminar will update you with latest norms of writing SOP in laboratory to clear the inspections and audits!
SOP in laboratory is one of the top-most priorities for professionals. Starting from freshly hired interns to seasoned researchers – a standard operating procedure maintains the uniformity of the lab for every worker.
This is specifically important to handle critical chemicals during drug manufacturing process. For instance, hazardous chemicals like carcinogens, acutely toxic chemicals, and reproductive toxins need to be handled with care.
This seminar focuses on avoiding any instance of non-compliance and empower professionals to curate a well-written SOP in pharmaceutical industry.
This 2-Day Virtual Bootcamp is designed to empower laboratory professionals to craft and implement SOPs that not only comply with FDA, EPA, and OSHA standards but also streamline workflows and minimize risks.
What You Will Learn:
-
- Develop Comprehensive SOPs: Master the art of writing detailed protocols that ensure consistency and accuracy across all laboratory processes.
- Role Clarity and Structure: Clearly define roles and responsibilities to enhance coordination and efficiency within your team.
- Risk Management: Learn how to proactively identify potential errors and implement corrective measures without disrupting the workflow.
- Practical Application: Gain both theoretical insights and practical skills in applying SOPs to real-world scenarios in the pharmaceutical industry.
- Maintenance and Compliance: Understand the importance of regular updates and maintenance of SOPs to stay ahead of regulatory changes.
Why This Training is Essential:
-
- Reduce PI Involvement: Streamline processes to decrease principal investigator (PI) oversight, allowing more autonomous laboratory operations.
- Enhance Safety and Efficiency: Implement SOPs that address the safe handling of hazardous materials and conduct of complex procedures, ensuring both safety and precision.
- Scalability: Equip yourself with the knowledge to scale experiments with minimal errors, optimizing both time and resources.
Key Takeaways:
Participants will leave the bootcamp with a solid framework for writing and implementing SOPs that not only meet compliance requirements but also foster a culture of continuous improvement and safety in the laboratory.
Join Now!
Standard Operating Procedures (SOPs) are the backbone of laboratory efficiency and compliance.
Standard operation procedures being the centre of attention for FDA, EPA, and OSHA – you need to implement the right practices in your laboratory. This seminar will update you with latest norms of writing SOP in laboratory to clear the inspections and audits!
SOP in laboratory is one of the top-most priorities for professionals. Starting from freshly hired interns to seasoned researchers – a standard operating procedure maintains the uniformity of the lab for every worker.
This is specifically important to handle critical chemicals during drug manufacturing process. For instance, hazardous chemicals like carcinogens, acutely toxic chemicals, and reproductive toxins need to be handled with care.
This seminar focuses on avoiding any instance of non-compliance and empower professionals to curate a well-written SOP in pharmaceutical industry.
This 2-Day Virtual Bootcamp is designed to empower laboratory professionals to craft and implement SOPs that not only comply with FDA, EPA, and OSHA standards but also streamline workflows and minimize risks.
What You Will Learn:
-
- Develop Comprehensive SOPs: Master the art of writing detailed protocols that ensure consistency and accuracy across all laboratory processes.
- Role Clarity and Structure: Clearly define roles and responsibilities to enhance coordination and efficiency within your team.
- Risk Management: Learn how to proactively identify potential errors and implement corrective measures without disrupting the workflow.
- Practical Application: Gain both theoretical insights and practical skills in applying SOPs to real-world scenarios in the pharmaceutical industry.
- Maintenance and Compliance: Understand the importance of regular updates and maintenance of SOPs to stay ahead of regulatory changes.
Why This Training is Essential:
-
- Reduce PI Involvement: Streamline processes to decrease principal investigator (PI) oversight, allowing more autonomous laboratory operations.
- Enhance Safety and Efficiency: Implement SOPs that address the safe handling of hazardous materials and conduct of complex procedures, ensuring both safety and precision.
- Scalability: Equip yourself with the knowledge to scale experiments with minimal errors, optimizing both time and resources.
Key Takeaways:
Participants will leave the bootcamp with a solid framework for writing and implementing SOPs that not only meet compliance requirements but also foster a culture of continuous improvement and safety in the laboratory.
Join Now!
Why you should attend
-
- Frustrated by recurring lab errors and inconsistencies?
- Is outdated documentation slowing down your lab?
- Is inconsistent data compromising your QC reports?
- Overwhelmed by the complexity of new lab protocols?
- Concerned about rising lab safety incidents?
If any of these resonate, you cannot afford to miss this course!
Standard Operating Procedures (SOPs) are not just regulatory requirements; they are essential tools that ensure safety, efficiency, and uniformity in laboratory environments. From newly onboarded interns to seasoned researchers, understanding and implementing robust SOPs is critical for maintaining high standards of operation across the board.
Addressing the Critical Need for Compliance:
-
- The lack of a well-defined SOP can lead to severe consequences in drug manufacturing and other critical laboratory processes.
- Without clear procedures, laboratories are prone to errors that can compromise data integrity, lead to safety hazards, and incur heavy regulatory penalties.
- This class focuses on preventing these issues by empowering professionals to develop and enforce SOPs that meet and exceed industry standards.
Safety in Handling Hazardous Materials:
-
- Handling hazardous chemicals—such as carcinogens, acutely toxic chemicals, and reproductive toxins—requires meticulous care and precision.
- A lapse in following proper procedures can lead to dangerous exposures and health risks for laboratory staff and potentially catastrophic environmental impacts.
This seminar will provide detailed guidance on crafting SOPs that specifically address the safe management of these high-risk substances, ensuring that all safety protocols are rigorously followed.
Uniformity Across the Board:
-
- A well-implemented SOP ensures that every team member, regardless of their experience level, follows the same procedures, thus maintaining uniformity across all laboratory operations.
- This is especially crucial in environments where the quality and consistency of results are paramount.
- By attending this class, professionals will learn how to create a coherent framework that standardizes practices and reduces variability in lab processes.
Empowerment Through Knowledge:
-
- This class is designed to turn potential vulnerabilities into strengths by educating participants on both the theoretical and practical aspects of SOP development.
- Professionals will be equipped to not only write but also critically evaluate and improve existing procedures.
- This proactive approach ensures ongoing compliance and operational excellence.
Benefits of a Well-Written SOP:
A robust SOP does more than comply with regulatory requirements—it enhances operational efficiency, reduces waste, and minimizes the need for corrective actions during audits.
By attending this seminar, professionals will gain the skills needed to create SOPs that are not only compliant but also optimized for today’s fast-paced, ever-evolving laboratory environments.
This comprehensive training is a must for any laboratory professional who aims to uphold the highest standards of safety and compliance while fostering an environment of continuous improvement and operational excellence.
Register Now!
-
- Frustrated by recurring lab errors and inconsistencies?
- Is outdated documentation slowing down your lab?
- Is inconsistent data compromising your QC reports?
- Overwhelmed by the complexity of new lab protocols?
- Concerned about rising lab safety incidents?
If any of these resonate, you cannot afford to miss this course!
Standard Operating Procedures (SOPs) are not just regulatory requirements; they are essential tools that ensure safety, efficiency, and uniformity in laboratory environments. From newly onboarded interns to seasoned researchers, understanding and implementing robust SOPs is critical for maintaining high standards of operation across the board.
Addressing the Critical Need for Compliance:
-
- The lack of a well-defined SOP can lead to severe consequences in drug manufacturing and other critical laboratory processes.
- Without clear procedures, laboratories are prone to errors that can compromise data integrity, lead to safety hazards, and incur heavy regulatory penalties.
- This class focuses on preventing these issues by empowering professionals to develop and enforce SOPs that meet and exceed industry standards.
Safety in Handling Hazardous Materials:
-
- Handling hazardous chemicals—such as carcinogens, acutely toxic chemicals, and reproductive toxins—requires meticulous care and precision.
- A lapse in following proper procedures can lead to dangerous exposures and health risks for laboratory staff and potentially catastrophic environmental impacts.
This seminar will provide detailed guidance on crafting SOPs that specifically address the safe management of these high-risk substances, ensuring that all safety protocols are rigorously followed.
Uniformity Across the Board:
-
- A well-implemented SOP ensures that every team member, regardless of their experience level, follows the same procedures, thus maintaining uniformity across all laboratory operations.
- This is especially crucial in environments where the quality and consistency of results are paramount.
- By attending this class, professionals will learn how to create a coherent framework that standardizes practices and reduces variability in lab processes.
Empowerment Through Knowledge:
-
- This class is designed to turn potential vulnerabilities into strengths by educating participants on both the theoretical and practical aspects of SOP development.
- Professionals will be equipped to not only write but also critically evaluate and improve existing procedures.
- This proactive approach ensures ongoing compliance and operational excellence.
Benefits of a Well-Written SOP:
A robust SOP does more than comply with regulatory requirements—it enhances operational efficiency, reduces waste, and minimizes the need for corrective actions during audits.
By attending this seminar, professionals will gain the skills needed to create SOPs that are not only compliant but also optimized for today’s fast-paced, ever-evolving laboratory environments.
This comprehensive training is a must for any laboratory professional who aims to uphold the highest standards of safety and compliance while fostering an environment of continuous improvement and operational excellence.
Register Now!
Course Agenda
Looking for a customized version of this training tailored specifically to your team’s needs and delivered at your convenience?
-
- Contact us at support@compliancemeet.com to explore your options!
- We offer tailored sessions that focus on your specific areas of interest, available online or in-person to fit your schedule.
Day 01: 4-hrs
Session 1
- What is the intention and role of SOPs?
- What tasks require SOPs?
- How do the network of SOPs within the lab support each other?
- How is an SOP structured/formatted?
Session 2
- What are the compliance requirements for an SOP?
- Descriptions of the roles and responsibilities of people involved in the SOP process.
Session 3
- Overview of various standard methods:
- The Regulatory Compliance Method
- The Scientific Published-Literature Method
- The Industrial Standard Method (ASTM and ISO methods)
- How to assess if a standard method can be directly used as an SOP?
- Converting a standard method to an acceptable SOP.
Session 4
- How to create an SOP?
- SOP for a new task
- SOP for a new methodology
- SOP for a standard method
Day 02: 4-hrs
Session 1
- The interplay within the lab to improve the draft SOP:
- Reviewing the first attempt
- Iterations and assessing compliance achievement
Session 2
- The implementation of the SOP:
- Training
- Documentation of initial training
- Ongoing proficiency testing requirements
Session 3
- Monitoring and assessing the SOP for changes:
- When should an SOP be revised?
- Revising the SOP: Documentation and approval process
- Using a method timeline to track changes
Session 4
- Requirements for archiving and documentation:
- Determining which SOP to use when
- Additional requirements: facility requirements, purchasing guidelines, safety issues, methods of reporting (including standard forms and information to be reported)
BONUS:
-
- PDF copy of the presentation handout for your future reference.
- Soft copy of the certificate of completion on request.
- Q&A Session with the Presenter: Get your pressing questions answered verbally, via chat or email
Looking for a customized version of this training tailored specifically to your team’s needs and delivered at your convenience?
-
- Contact us at support@compliancemeet.com to explore your options!
- We offer tailored sessions that focus on your specific areas of interest, available online or in-person to fit your schedule.
Day 01: 4-hrs
Session 1
- What is the intention and role of SOPs?
- What tasks require SOPs?
- How do the network of SOPs within the lab support each other?
- How is an SOP structured/formatted?
Session 2
- What are the compliance requirements for an SOP?
- Descriptions of the roles and responsibilities of people involved in the SOP process.
Session 3
- Overview of various standard methods:
- The Regulatory Compliance Method
- The Scientific Published-Literature Method
- The Industrial Standard Method (ASTM and ISO methods)
- How to assess if a standard method can be directly used as an SOP?
- Converting a standard method to an acceptable SOP.
Session 4
- How to create an SOP?
- SOP for a new task
- SOP for a new methodology
- SOP for a standard method
Day 02: 4-hrs
Session 1
- The interplay within the lab to improve the draft SOP:
- Reviewing the first attempt
- Iterations and assessing compliance achievement
Session 2
- The implementation of the SOP:
- Training
- Documentation of initial training
- Ongoing proficiency testing requirements
Session 3
- Monitoring and assessing the SOP for changes:
- When should an SOP be revised?
- Revising the SOP: Documentation and approval process
- Using a method timeline to track changes
Session 4
- Requirements for archiving and documentation:
- Determining which SOP to use when
- Additional requirements: facility requirements, purchasing guidelines, safety issues, methods of reporting (including standard forms and information to be reported)
BONUS:
-
- PDF copy of the presentation handout for your future reference.
- Soft copy of the certificate of completion on request.
- Q&A Session with the Presenter: Get your pressing questions answered verbally, via chat or email
Who is this course for
Maximize the Learning Experience in A Group Setting!
This bootcamp is ideal for laboratory technicians, QA/QC analysts, and research scientists who are involved in setting up or maintaining laboratory standards and protocols.
It’s also crucial for those looking to update their skills in line with current regulatory expectations.
-
- Laboratory Technicians
- Quality Assurance (QA) Managers
- Quality Control (QC) Analysts
- Research Scientists
- Compliance Officers
- Laboratory Managers
- Process Engineers
- Regulatory Affairs Professionals
- Safety OfficersPharmaceutical Manufacturers
Maximize the Learning Experience in A Group Setting!
This bootcamp is ideal for laboratory technicians, QA/QC analysts, and research scientists who are involved in setting up or maintaining laboratory standards and protocols.
It’s also crucial for those looking to update their skills in line with current regulatory expectations.
-
- Laboratory Technicians
- Quality Assurance (QA) Managers
- Quality Control (QC) Analysts
- Research Scientists
- Compliance Officers
- Laboratory Managers
- Process Engineers
- Regulatory Affairs Professionals
- Safety OfficersPharmaceutical Manufacturers
Instructor Profile
John C. Fetzer, has had over 30 year experience in HPLC methods development. He has authored or co-authored over 50 peer-reviewed papers on liquid chromatography, has served on the editorial advisory boards of the Journal of Chromatography, Analytical Chemistry, and Analytical and Bioanalytical Chemistry.