What is an SOP? In an organization, it is an operation-specific procedure that gives a thorough description of all the activities needed to carry out tasks that comply with industry-related regulations, State laws, and many a time, the methods the organization itself has prescribed for its business. Documentation is at the heart of a solid SOP. The core of developing an SOP is how the organization systematizes its processes and documents them.
A procedure must necessarily describe the manner in which to carry out a certain activity, or what is called the “how to” of it. SOPs are a set of standards, procedures, principles and policies that go on to streamline core areas such as finance, HR, administration, marketing and many others.
Many advantages and benefits accrue from putting in place a sound SOP. These are some of them:
- The organization’s efficiencies go up
- They help put in place a healthy workplace environment, and help meet regulatory requirements
- The organization’s products and services carry higher quality, and are more consistent and reliable
- The error rate in most activities comes down
- SOPs are a ready reference to resolving disputes between Business Associates.
Complete understanding of SOPs
Want to understand the nitty-gritty of how to implement an SOP that meets all these requirements, and helps your organization reach its business and other goals? A two-day seminar from GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, will show you how.
Peggy Berry, President & CEO, Synergy Consulting, where she provides consulting services to companies in all aspects of drug development, will be the Director of this seminar. She also provides group and one-on-one training in drug development, regulatory affairs and project management topics. In an earlier role, she was an editor-in-chief of Fundamentals of US Regulatory Affairs, 6th edition (RAPS, MD 2010). Editor of “Choosing the Right Regulatory Career” (RAPS, MD 2010) and author of “Communication & Negotiation” (RAPS, MD 2011).
An understanding of how to write SOPs
Peggy will lead the participants into an exploration of important aspects of SOPs, such as what they are, what they are used for, when they are required, how to write them effectively for compliance and for implementation within the organization, and how to ensure effective communication and training of procedures within the SOPs.
An SOP is a set of standardized procedures and processes and should have as much detail in it as to ensure that tasks are performed consistently each time they are done. SOPs should comply with domestic, regional and global regulations and guidelines across all the functions they describe. It is not uncommon to come across reference to lack of SOPs or not following SOPs as frequent reasons for citations by the regulatory agencies around the world. Whenever this happens, organizations must correct those SOP-related deficiencies.
At this seminar, Peggy will explain all these aspects of SOPs. She will cover the following areas:
- Regulatory requirements for GCP SOPs
- Regulatory requirements for GMP SOPs
- Legal requirements for SOP creation and maintenance
- Types of SOPs
- Formats and essential components of SOPs
- How to effectively write an SOP to ensure compliance
- SOP training and implementation
- Deviations from and changes to SOPs.
Professionals at all important levels of an organization that deal with SOPs will benefit immensely from this session. These include Directors, Managers, Supervisors, Auditors, those in regulatory operations, Clinical investigators, site managers and contracting personnel, Project managers, medical writers, Compliance officers, and those in the areas of clinical operations and data management.
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