Dublin, Oct. 25, 2023 (GLOBE NEWSWIRE) -- The "Effective SOP Writing Masterclass - Training and Compliance in the Pharmaceutical Industry" has been added to ResearchAndMarkets.com's offering.
This intensive masterclass is tailored to meet the unique regulatory and compliance needs of the pharmaceutical sector, especially concerning the creation and management of Standard Operating Procedures (SOPs).
SOPs are the linchpin of both routine training and compliance within pharmaceutical manufacturing realms. However, often employees overlook the regulatory commitments they enter into when documenting their processes. This masterclass is meticulously designed to enlighten attendees on crafting SOPs with an ideal level of detail that not only fulfills regulatory mandates but significantly elevates training quality and job performance.
The curriculum delves into the detrimental effects poorly drafted procedures can have on production and compliance, and provides practical tools for avoiding common errors while revising existing procedures. It also explores the symbiotic relationship between well-structured documentation and impactful training, emphasizing the importance of involving training departments from the inception of SOP development.
There exists a profound interconnection between SOPs, training curricula, and the qualification of employees to execute their tasks autonomously. This masterclass will provide a roadmap on how to seamlessly integrate SOPs into training curricula, which is crucial evidence for internal auditors and regulatory bodies that job roles are correctly delineated and documented.
A significant portion of the course is dedicated to understanding and implementing continuous assessment strategies to gauge learners’ retention of SOP content. This is crucial for instigating a culture of continual improvement and averting procedural deviations. The tools for such assessments are likely already embedded in your company’s training software, and this course will guide you on how to leverage them effectively.
Learning Objectives Highlighted in the Masterclass:
- Mastery in drafting SOPs that enhance training effectiveness and minimize errors.
- Grasping the regulatory implications encapsulated in an SOP.
- Identifying the hallmarks of a well-drafted SOP and distinguishing it from a poorly written one.
- Defining processes succinctly through effective interaction with the SOP process owner and/or author.
- Incorporating SOPs effectively into the position curricula of employees.
- Understanding the nexus between SOPs and job performance, and assessing retention of SOP content during training.
Who Should Attend:
This masterclass is a golden opportunity for individuals responsible for process ownership, procedure writing/reviewing, and managing training within a GMP (Good Manufacturing Practice) environment in the pharmaceutical industry. The course is particularly beneficial for personnel from:
- Quality, Production, Compliance, Engineering, R&D, IT Departments.
- Management teams tasked with creating or reviewing procedures.
The masterclass is structured into ten interactive sessions spanning over two days, each session meticulously crafted to address the different facets of SOP writing, compliance, and training in a pharmaceutical setting. The participants will engage in a blend of theoretical discussions, practical exercises, and simulation activities designed to provide a holistic understanding and hands-on experience.
Seminar Objectives
- Regulatory requirements for SOPs
- Using process excellence tools to create a robust process and procedure
- What commitments you make when you put your process in writing
- Keeping training in mind while writing procedures
- Consequences of noncompliance
- Define the parameters of an effective SOP
- How your foundation keeps subsequent steps from going awry
- Why poorly written procedures have a negative impact on production
- What identifies a poorly written procedure
- Compliance risks with ambiguity or excessive detail
- Avoiding pitfalls in revising SOPs
- Interact with the SOP process owner/author to improve the writing of procedures
- Integrate the SOP effectively into the position curricula of employees
- Relationship between SOPs and employees' training curricula
- Why the training department needs to be in the loop at the start of the SOP development process
- Relationship between SOPs, curricula and qualification to perform tasks
- Retention of the content at the training stage
- The implications of good training for successful SOP execution
- Perform an ongoing assessment of knowledge retention of SOPs for continuous improvement
- Review of learning objectives
- Knowledge assessment
This masterclass on effective SOP writing is set to empower professionals in the pharmaceutical industry to navigate the regulatory landscape with enhanced confidence and expertise, thereby contributing to an elevated standard of compliance and training within the industry.
For more information about this seminar visit https://www.researchandmarkets.com/r/jgt9ng
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