#work instructions

Ansomat: the company that thinks with you

Smarter production starts here

What if your shop floor no longer tolerates mistakes? If every screw is in the right place, every action is properly logged, and even a new operator immediately knows what to do? That’s not a dream for the future — it’s what Ansomat makes possible today.

Ansomat is a Belgian technology company with deep practical experience. Since 1996, they’ve been building digital solutions for the manufacturing industry. Not distant software, but tools that precisely meet what production companies really need: clarity, speed, and above all, reliability.

Ansomatic: your digital work partner

At the heart of their offering is Ansomatic, a platform that feels like a smart work partner. No more worn-out manuals or outdated process binders, but clear, visual instructions on a screen. Your operator doesn’t need to search or guess — Ansomatic shows exactly what needs to be done, step by step. Every detail is correct.

What makes it even better? Ansomatic works in sync with your machines. It reads sensors, checks via cameras whether a part is correctly placed, and only allows the process to continue when everything is right. No extra inspections, no time lost. Everything flows with maximum certainty.

People remain central

You might think: with all this technology, won’t people become less relevant? Not at Ansomat. On the contrary. Their system is designed to empower people, not replace them. Thanks to Operator Guidance, even new employees can get to work immediately. They receive clear instructions and make fewer mistakes. This means less pressure, more confidence, and faster independence.

Through Human Analytics, you also gain insight into where processes run smoothly, where delays occur, and where extra support is needed. This isn’t about control for the sake of control, but insights that help you train better, improve more effectively, or even rethink how work is organized.

For every screw, in every sector

Ansomatic is already in use across diverse production environments: from aerospace to automotive, from heavy machinery to electronics. In each of these sectors, reliability is key. One mistake can cost thousands of euros or compromise safety.

That’s why the system works just as well in a small work cell as it does in a fully automated production line. It’s flexible, scalable, and always focused on your specific needs.

Thinking alongside the best

Ansomat doesn’t build in isolation. They work with international technology partners such as Cognex and customers like Spirit AeroSystems. Together, they continuously improve the platform. Their approach has proven successful, as shown by international recognition: the company won the BLCC Golden Bridge Award as "Best Tech Company."

The next Step? Just take it

Want to make your production process smarter, safer, and more consistent? Now is the time. Request a demo and discover how Ansomatic seamlessly adapts to your company, your people, and your way of working.

Smarter production doesn’t start by changing everything. It starts by changing what matters. And Ansomat helps you do that, step by step, just like their platform.

Standard Work Pro is built for factories that want to move beyond outdated SOPs and inconsistent training.

It helps when your operators are doing the same task in five different ways, new hires struggle to follow printed instructions, or changes never make it to the floor in time.

Course "Key Factors to Write an Effective Standard Operating Procedure (SOP) and Work Instructions (WIs)" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

 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. 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.

 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

 Speaker:

 David R. Dills

Regulatory Affairs & Compliance Consultant, 

David R. Dills, Regulatory & Compliance Consultant with more than 24 years of hands-on experience and a proven track record within the FDA regulated industry, has an extensive regulatory and compliance background with Class I/II/III and IVD devices, pharmaceutical operations, and manages activities within the global regulatory and compliance space. He manages quality, regulatory and compliance projects with multiple competing priorities having a direct impact on site operations and commercial opportunities and develops strategies for governmental approval to introduce new products to market, provides guidance on regulatory and compliance requirements and prepares/reviews worldwide submissions/dossiers/technical files and addresses global regulatory requirements. Background encompasses broad capabilities in quality systems, validation, regulatory affairs, compliance, auditing, interfacing with the regulatory agencies, addressing enforcement actions and mitigating compliance exposure for companies via remediation, compliance engineering support, post-marketing surveillance and vigilance reporting; clinical affairs, establish and/or remediate Quality Management and documentation systems for GxP compliance; preparation for ISO 13485 registration and CE Mark; and multi-country product registrations and licensing; and working with Notified Bodies, and AR's. David manages regulatory problems (e.g. AE's, MDRs, Agency enforcement, complaints/investigations, field alerts/recalls) related to development, manufacturing, and commercialization, and recommends action to senior leadership to ensure effective resolution for manufacturers to achieve sustainable and proven compliant systems. This is based on analyzing the benefits/risks for informed decision-making and interprets the regulatory precedents and new legislation. He strives to optimize business performance through proactive strategies to mitigate compliance exposure by providing strategic and tactical solutions that facilitate the achievement of regulatory and quality milestones. David has been previously affiliated with well-known device manufacturers and service providers, including a global CRO and has served in various quality, regulatory and compliance management and advisory capacities with increasing responsibilities. David is an industry speaker and author of technical and compliance related topics published in industry journals. Please refer to his profile provided herein for additional information about his background and areas of interest and focus.

 Location: Philadelphia, PA Date: May 12th & 13th, 2016 Time: 9:00 AM to 6:00 PM

 Venue: Hilton Garden Inn Philadelphia Center City

Address: 1100 Arch Street, Philadelphia, Pennsylvania, 19107, USA

 Price:

(Without Stay) Price: $1,295.00 (Seminar for One Delegate)

Until March 31, Early Bird Price: $1,295.00 from April 01 to May 10, Regular Price: $1,495.00

(With Stay) Includes Price: $1,695.00 (Seminar for One Delegate)

Until March 31, Early Bird Price: $1,695.00 from April 01 to May 10, Regular Price: $1,895.00

Quick Contact:

NetZealous DBA as GlobalCompliancePanel

Phone: 1-800-447-9407

Fax: 302-288-6884

Email: [email protected]      

Website: http://www.globalcompliancepanel.com/

Registration Link - http://bit.ly/writing-enforcing-effective-SOPs-Philadelphia

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Summary:GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will start a RAPS pre-approved webinar on the matter, €Key Factors against Write an Effective Standard Operating Doings (SOP) and Steering Binary system (WIs)€ on November 7. Angela Bazigos, CEO of Reference Technologies Silicon Wadi, Inc., an FDA Compliance company, will be the speaker at this webinar, which earns rise to 2.00 RAC credits towards a participant's RAC recertification upon full completion. ----------------------------------------------------------------------------------------------------------------- Account:It is an irony of sorts that although companies that are regulated thanks to the Code of Chief of police Regulations alike as Appellation 21 and Title 493 are prescript in obedience to statute unto beat Standard On foot Procedures (SOPs); there is no guidance accompanying how to write, organize and maintain these critical guidance documents. Because of this, many companies write SOPs in their own interpretative and subjective indite. Almost galactically, these rasher up getting written in many-sided and incomprehensible ways. As an example a cracking, orthodoxy becomes a casualty, because the way open door which this is written is impossible to comprehend for the others in the religious order. Obscurely written documents obligation the FDA's attention when other self turn up as representing audit of these documents. This webinar is intended to give participants an understanding of how into write their SOP's with transparence. It makes them look at ways by whichthere is clarity, pellucidity and flow in their SOP's, which is after all put together, a clearing the decks for getting FDA approval. This webinar will lesson participants ways to write SOP's that are discernible, concise and well reproducible - just what the FDA expects pertinent to them. Ms. Bazigos will cover the following areas during this two-hour discussion: o SOPs and their relation versus the regulations o SOPs as an example perish of the company's directive infrastructure o SOP on SOPs and how until ensure conciseness, consistency and ease of what is done o Risk Based approach straddleback SOP Best Practices for creation and maintenance o Military training on SOPs o Tools so SOP tracking and when is validation required o What the FDA looks for in SOPs during an inspection ----------------------------------------------------------------------------------------------------------------- Though:November 7, 10:00 ACK EMMA PDT | 01:00 PM EDT ----------------------------------------------------------------------------------------------------------------- Thanks to whom:Angela Bazigos is the CEO of Touchstone Technologies Silicon Valley, Inc. an FDA Compliance company. She has almost 30 years' experience means of access the Life Sciences industry and has applied to patents aimed at speeding up Software Compliance. Superego is a member about the SQA CVIC (Society of Characteristic Good hope Computer Validation Initiative Committee), DIA and RAPS and conducts classes pertinent to 21 CFR 11, Computer Systems Validation, Consistency Strategy and Job of work Management. <\p>

More recently, Palsy. Bazigos was selected on co-author Computerized Systems modish Clinical Research\Electric stream Data Quality and Data Personal identity Concepts with FDA, DIA and Academia.<\p>