Course "Writing & Managing Effective SOPs" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
Every biopharmaceutical company has SOPs, and new staff members are told that the company "has to have them" and that each employee "has to follow them". But why do there have to be SOPs and why must we follow them as written? And how can we do this effectively?
Most people naturally want to do a good job. Successful managers recognize this fact and seek to channel workers' efforts in ways that will benefit the business. Well-written Standard Operating Procedures (SOPs) provide direction, improve communication, reduce training time, and improve work consistency. The purpose of an SOP is to provide detailed instructions on how to carry out a task so that any team member can carry out the task correctly every time. The SOP development process is an excellent way for managers, workers, and technical advisers to cooperate for everyone's benefit. A very positive sense of teamwork arises when these parties work together toward common goals.
Perhaps if everything always executed as planned then we would not need procedures, but this is not the case in the real world. An SOP or Standard Operating Procedure is used to ensure business processes are well thought through, that each task in a process is performed the same way every time, and important data is recorded, along with errors or deviations so corrective action can be taken. Standard Operating Procedures used in combination with planned training and regular performance feedback lead to an effective and motivated workforce. Managers and advisers benefit from consistent work performance and predictable results. Workers benefit from increased confidence and a clear sense of achievement.
Producing a high-quality product at a profit depends on the consistent operation of all systems within the company. SOPs describe the basic systems shared by all company employees. Company success depends on how well these systems work together to produce large volumes of high-quality product that is safe and effective for patients and consumers.
Good procedures and work instructions provide a way to communicate and apply consistent standards and practices within your organization.
- save time and mistakes
- reduce training costs
- ensure consistent results
- empower the workforce
- get read and used
- support quality goals
- enable you to delegate work
- But, BAD procedures, can be as disastrous as no procedures at all!
- cause errors and frustration
- increase training costs
- waste time and money
- detract from quality goals
- don’t get read or used
- Finally, for the above reasons, ALL regulatory agencies expect that a company shall have written procedures and such procedures will be followed. Just like "they" told you!!
At The End Of The Seminar Attendees Will Have Learned:
- Why would I want SOPs?
- What will they do for me?
- How SOPs fit in with laws and regulations
- How to organize the SOP writing effort
- Steps to developing an SOP
- Presenting the SOP
- Educate employees about the new SOP
- Control procedural shift
- Set up an evaluation and review method for continuous SOP improvement
Why should you attend:
This hands-on seminar will help you with creating and following effective Standard Operating Procedures (SOP) to streamline your business and achieve compliance. This seminar will show you how to describe all the tasks that are essential for your business success, how to do these tasks, and who is responsible for the tasks listed.
Specific benefits include:
Reduced learning curve/training time for new employees
When someone is new on the job, your well-written and researched SOP can be a lifeline to them to be able to know how things work. For instance, you can ask your new employee to make all the arrangements for you to organize and attend a workshop in another city. By referring to the SOP, your new employee will know exactly which travel agency you use with their contact details, which type of car to hire/service to use, how many quotes to get regarding the venue, how to communicate with the workshop delegates, etc. without having to ask you about it all. It’s a great time-saver and confidence booster for the new employee.
Ensured business continuity
When a key staff member is on leave or not in the office for some reason, work does not have to stand still. By referring to the SOP someone else can take over the urgent tasks and do them correctly the first time.
The SOP makes it easy to find out what policies and procedures are in place to handle repetitive situations/tasks.
Delegating tasks becomes a no-brainer
A good SOP will include the organogram of the business, as well as have a short job description and contact details for each staff member. If you need to delegate a certain task, you can see at a glance who will be able to help you or advise you. You can stop micromanaging, as it is clear who is responsible for what.
Ensure that your clients are getting the best possible experience with you
Because there is a standard way of dealing with client queries, refunds, promotions, follow-up etc., you can make sure that each client is treated fairly and equally, enhancing their interactions with you. You thus provide the best possible client service.
An SOP is a living document, which is subject to change. (It is good to review it quarterly). It is therefore useful to have it in electronic format on a web-based collaborative system so that all employees have access to the latest version.
Do you need to put together a clear and straightforward SOP, compiled in simple language to convey practical information? Your business will thank you for it!
- Medical Device
- Radiological Health
- Blood Products
- Companion Animals
Day 1 Schedule
Lecture 1 (90 Mins): Introduction
High Level Writing Effective SOPs
Lecture 2 (90 Mins): Founding Principles
What is an SOP
When to have an SOP
Lecture 3 (90 Mins): Founding Principles (cont'd)
What the SOP should say
Where to put the output
Lecture 4 (90 Mins): Writing, Reviewing, Approving and Posting
Who writes SOPs
Document a stable process
Exercise – creating an SOP
Day 2 Schedule
Lecture 1 (90 Mins): Writing, Reviewing, Approving and Posting
Mapping a new process
The SOP template
SOP Review & Approval
Posting: Setting up for Success
Lecture 2 (90 Mins): Maintaining SOPs: Maintaining Compliance
Deviations from Controlled Procedures
Active SOP Maintenance
Lecture 3 (90 Mins): Helping Staff Follow SOPs
Training on SOPs
Department Managed Documents
Lecture 4 (90 Mins): Additional Topics
Where to start writing an SOP
SOPs during mergers and acquisitions
Quiz: Jeopardy!!!! (30 minutes)
Writing & Managing Effective SOPs
Ms Angela Bazigos,
Touchstone Technologies Silicon Valley
Angela Bazigos.CEO of Touchstone Technologies Inc. She has 40 years of experience in the Life Sciences & Healthcare Industries. Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety, Turnarounds and Business Development. Past employers / clients include Roche, Novartis, Genentech & PriceWaterhouseCoopers. Positions include Chief Compliance Officer at Morf Media. Co-authored & prototyped 21 CFR 11 guidance with FDA. Co-authored Computerized Systems in Clinical Research w/ FDA. Patent on speeding up software compliance. Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom. National Trainer for Society of Quality Assurance. Comments / collaborates with FDA on new guidance documents. Former President of Pacific Regional Chapter of Society of Quality Assurance. Stanford’s Who’s Who for Life Sciences.
Who will benefit:
- VP of IT
- Director of IT
- Quality Managers
- Project Managers (for CSV / IT)
- Validation Specialists
- Database Administrators
- System Administrators
- Directors / Senior Directors of Discovery
- Directors / Senior Directors of Development
- Directors / Senior Directors of Commercialization
- Document Managers
- Training Managers
- Outsource Service Providers
Hilton Garden Inn Chicago OHare Airport
2930 S River Rd
From O'Hare International Airport:
10000 W O'Hare Ave, Chicago, IL 60666.
Head southwest on I-190 W (141 ft.)
Take the exit toward Bessie Coleman Dr-
Use the right 2 lanes to turn right onto Bessie Coleman Dr-
Use the right lane to take the Interstate 190 ramp to Interstate 90/Chicago/Interstate 294-
Merge onto I-190 E-
Keep right to continue on Exit 1A, follow signs for North River Road and merge onto Des Plaines River Rd/N River Rd-
(Continue to follow N River Rd.)
Destination will be on the left-
Hilton Garden Inn Chicago OHare Airport-
2930 S River Rd, Des Plaines, IL 60018.