NetZealous DBA as GlobalCompliancePanel, SFO, CA
09-02-2017
Overview: Writing SOPs or procedural documents can be challenging at times. However, writing SOPs is overall a straightforward process. However, enforcing what you already created and implemented in the pipeline is another story. The term SOP is very obvious. We have seen "clearly written description of how specific tasks are to be done." Another satisfactory definition would be "detailed written instructions that achieve the uniformity of the performance of a specific function." Is the firm doing what the regulations specify? Is the firm doing what their procedures specify? If you are medical device or a pharmaceutical manufacturer, these definitions come as no surprise because when it comes to FDA regulations and guidance documents "establish" means to define, to document (in writing or electronically) and to implement. Who will benefit: This Seminar will provide valuable assistance and guidance to pharmaceutical, medical device and biotechnology manufacturers and other firms in the life sciences industry who require a refresher session on writing and enforcing their own SOPs and internal procedures or for those new to this area who desire to gain a better understanding of the SOP process. The employees who will benefit include basically anyone and everyone at your organization who are required to write and/or comply with SOPs, including all levels of management and departmental representatives and those who desire a better understanding or a "refresh" overview of the SOP process from start to finish, including: - Regulatory Affairs
- Clinical Affairs
- Quality Assurance/Quality Control
- Compliance
- Marketing & Sales
- Manufacturing and Technical Services
- Engineering
- IT/MIS
- Executive Management
- Laboratory Operations
- Customer Service
- Clinical Research managers and personnel
- Specialists/SMEs in all departments
- QA/RA managers and personnel
- Quality System auditors
- Distributors/Authorized Representatives
- Legal Counsel
- Consultants
Agenda: Day 1 Schedule Lecture 1: The SOP end user, required sections and best practices for SOP development Lecture 2: Tips that help and work when you need to create, clear, concise procedures Lecture 3: Improve your writing skills Lecture 4: Development and formatting recommendations: Content and Structure Lecture 5: Reminders that you need to know when you critique your own procedures Lecture 6: FDA and overall global expectations and requirements for SOP development, implementation and enforcement Lecture 7: Create SOPs for the target audience Lecture 8: Provide appropriate level of details and use writing conventions Lecture 9: Have increased confidence in planning and writing your SOPs Lecture 10: Understand the industry standards for procedure writing, including typical components of documents, and using document templates Day 2 Schedule Lecture 1: Understand the full life cycle of SOPs Lecture 2: Understand how training is integral to document approval Lecture 3: Control, archival and disposal Lecture 4: Identify ways to avoid or reduce risk of regulatory compliance through better writing of your procedures. Lecture 5: Use various tools such as flowcharting to define a logical procedure Lecture 6: Write a concise, unambiguous SOP for its intended purpose and stay on-point and on-message Lecture 7: Ensure the document is written for the correct audience Lecture 8: Link SOPs to good documentation practices Lecture 9: Define clear responsibilities, roles and goals for personnel involved in SOP development Location: SFO, CA Date: February 9th & 10th, 2017and Time: 9:00 AM to 6:00 PM Venue: DoubleTree by Hilton Hotel San Francisco Airport Address: 835 Airport Blvd., Burlingame CA 94010-9949 Price: Price: $1,295.00 (Seminar Fee for One Delegate – Without Stay) Until January 10, Early Bird Price: $1,295.00 from January 11 to February 7, Regular Price: $1,495.00 Register for 5 attendees (With stay) Includes Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)* Register now and save $200. (Early Bird)
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