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.
The goal and emphasis with FDA is simple. Proof of "Establish" is the foundation. Is the firm doing what the regulations specify? Is the firm doing what their procedures specify? Are the procedures being followed and enforced by company personnel? SOPs are needed in regulated industries to give step-by-step instructions for performing a particular job or task. This session will provide a step-by-step overview and a snapshot of the procedure description, the process and format. The subject matter of a SOP may range from how to operate a piece of machinery to how to log into a particular software program. SOPs ensure consistency and reliability because they require training of all affected parties.
This session will address recent enforcement actions for SOP related violations but no surprise. Most of our enforcement actions are documentation related, i.e., SOP or other procedural documents. We will review examples from warning letters and then review the good and bad SOPs and templates. Standard operating procedures work best when they are designed to achieve specific results. Decide what business goals will be achieved through better management with SOPs and how those goals will be measured. The lack of or inadequate standard operating procedures (SOPs) continues to dominate the FDA's inspectional observations. Following SOPs are much more important than writing them. Even the best written SOPs are useless if they are not followed. SOPs are therefore the most popular documents audited by FDA and other Agencies, and certainly your auditors and customers.
This session will provide insightful and useful information by presenting topics associated with the writing, formatting, execution, management and global harmonization of SOPs. It also discusses good documentation practices required by companies to ensure GMP compliance and relates the role which SOPs play in achieving the required level of compliance and quality.
Areas covered in the session:
The SOP end user, required sections and best practices for SOP development
Tips that help and work when you need to create, clear, concise procedures
Improve your writing skills
Development and formatting recommendations: Content and Structure
Reminders that you need to know when you critique your own procedures
FDA and overall global expectations and requirements for SOP development, implementation and enforcement
Create SOPs for the target audience
Provide appropriate level of details and use writing conventions
Have increased confidence in planning and writing your SOPs
Understand the industry standards for procedure writing, including typical components of documents, and using document templates
Understand the full life cycle of SOPs
Understand how training is integral to document approval
Control, archival and disposal
Identify ways to avoid or reduce risk of regulatory compliance through better writing of your procedures.
Use various tools such as flowcharting to define a logical procedure
Write a concise, unambiguous SOP for its intended purpose and stay on-point and on-message
Ensure the document is written for the correct audience
Link SOPs to good documentation practices
Define clear responsibilities, roles and goals for personnel involved in SOP development
Who will benefit :
This webinar 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:
Inside Job: The Growing Internal Cyber-Threats and How to Protect Against Them
Quality Assurance/Quality Control
Marketing & Sales
Manufacturing and Technical Services
Clinical Research managers and personnel
Specialists/SMEs in all departments
QA/RA managers and personnel
Quality System auditors
Instructor Profile :
David R. Dills, Global Regulatory Affairs & Compliance Consultant currently provides regulatory affairs, compliance and quality consultative services for early-stage and established Class I/II/III device, In Vitro Diagnostics, cosmetics and bio/pharmaceutical manufacturers on the global landscape, and also has an accomplished record with more than 25 years of experience in the areas of Regulatory Affairs, Compliance and Quality Systems. He has been previously employed, with increasing responsibilities by medical device manufacturers and consultancies, including a globally recognized CRO and has worked directly with manufacturers engaged in compliance remediation activities and services involving consent decrees, CIA’s, warning letters, 483 observations, and customer generated compliance events, and prepares for and conducts QS and regulatory audits.
He has been directly involved with constructing, reviewing, and/ or remediating regulatory submissions, including 510(k), PMA, IDE applications, IND, BLA and NDA submissions, preparing Supplements, Amendments, U.S. Agent, works closely with the key stakeholders and Agency/Center Reviewers regarding submission meetings and negotiations; clinical affairs and study submissions; and provides regulatory submissions and post-market project leadership and guidance covering different therapeutic and medical specialties based on classification.
Mr. Dills has a strong background in the interpretation and applicability of FDA regulations, including 21 CFR 210/211, 820 QSR/cGMP, Quality System implementation and compliance requirements, GxP training, leads and directs activities for the registration and approval process and working with Agencies in Asia Pacific, EU and The Americas, including but not limited to FDA, European Medicines Agency–EMA, MHRH, ANVISA, PMDA, MOH, SFDA, TGA, and Health Canada; and defining and executing regulatory compliance, risk mitigation and remediation strategies in response to inspection findings. Additional activities include Pre-FDA Facility Inspections, Mock Audits/Due diligence and assessing state of readiness for Pre-approval inspection (PAI/PMA), proof of management oversight, facilitate and direct efforts for remediation planning and monitoring, and assessment of the critical sub-systems, records and document controls; and strives for reduction of regulatory compliance risk for companies.
About this Advertiser
GRC Training Solutions
#4512 LEGACY DR STE 100,
Attend this briefing and demonstration on Excel to unleash its powerful sensitivity tools. Get the full power out of your financial models. Improve the design of your models to take advantage of these tools in just 90 minutes.
Financial analysis is an area of opportunity and risk. Analysis should incorporate tests of sensitivity to changes in key variables using the most advanced tools available. Typical financial models do not effectively utilize these tools. This exposes the analyst to blind spots in their analysis. Analysts will want to obtain and become proficient in the use of the more sophisticated “what if” analysis tools of the trade.
Why Should you Attend Learn best practices for designing efficient forecasting models. Learn how to apply scroll bars, goal seek, data tables, and scenario manager to your models in just 90 minutes.
Experienced CGMA and financial analyst, Miles Hutchinson will demonstrate these tools for you using Microsoft ExcelTM. He will provide practical instructions and guidance for applying them and identify the key cautions to help you avoid potential misfires.
Areas Covered in the Webinar:
• 20 rules of effective model design
• Applying Scroll Bars to individual cells to flex them over their relative ranges with the touch of your mouse
• Using Goal Seek to discover how much a single variable must move to reach a desired outcome
• Using Data Tables with one or two-inputs to deliver an array of outcomes from your model in just seconds
• Using Scenario Manager to store selected groupings of inputs and resulting outcomes
o Use Scenario Manager to consolidate all ”versions” of your model into one file
o Use the standard Scenario Summary to compare your Scenarios automatically
• Expand your skills in financial modeling to a level you never dreamed of in just 90 minutes!
• Bonus – download a copy of the demo model along and the answer key to our demonstration!
Who Will Benefit:
• Financial Analysts
• Business Analysts
• Information Reporting Officers
• Tax Managers
• Compliance Officers
• Compliance Managers
• Accounting Managers
• Risk Managers
By Miles Hutchinson, CPA, CGMA,President,Sales Tax Advisors, Inc.
Miles Hutchinson is a CGMA and experienced businessman with over 35 years in the field. He has been an auditor with PriceWaterhouseCoopers and the Chief Financial Officer of a one billion dollar real estate development company. Miles is a professional speaker and consultant who has presented over 2,500 seminars and training sessions on a myriad of business and financial topics, like financial analysis and modeling, accounting, strategic planning, and compliance with the Sarbanes-Oxley Act. He is recognized as an expert in payroll and sales & use tax as well as financial modeling & analysis, business strategy and communications. He is the author of several useful accounting and tax tools available at www.soxpolicies.com and www.salestaxadvisors.com. His clients include, Abbott Labs, Bank of America, Boston Scientific, Citicorp, Corning, the FBI, the FDA, the Federal Reserve, GE, Pfizer, Siemens, US Marine Corps, and the US Army. Please visit his web sites to see how you can further benefit from his expertise.