System/Software Development Methodologies

Allergen mishaps in manufacturing are now a Class I Recall by the FDA (Food & Drug Administration), considered an adulterant in foods. It is the largest area for recalls in the US and growing at a staggering rate. Anyone wanting to know how to approach, improve or review their Allergen Management Program should participant to understand the latest information for Best Practice preventative controls.

This combined DMF (Drug Master Files) and Quality Agreement training will discuss the advantages for suppliers and drug product manufacturers in developing these arrangements together. Over time, there have been several misunderstandings between supplier / contractors and pharmaceutical / biologic finished product manufacturers. The root of many of the problems lie in a lack of a suitable agreement delineating roles, responsibilities and resolution to agreement to these issues. Part of these arrangements typically involve the development, support and updating of confidential technical files (Drug Master files), which allow suppliers to protect their confidential product and process information from each and every customer and share it only with the Agency.

Overview: The FDA's expectations for training new employees are summed up in 21 CFR 211.25(a), i.e., pharmaceutical professionals require the education, training and experience to complete their job functions. Onboarding new or transferred employees in a Pharmaceutical Good Manufacturing Practices (GMP) environment and ensuring compliance with these requirements create some unique challenges. Although FDA expectations provide some of the framework regarding types and frequency of training, there are decisions that the company will need to make in light of its evaluation of how to best achieve compliance for its employees, maintain a quality culture, and manage the work environment.

Overview: Identify elements of the business process framework for managing technology transfers. Explain benefits of technology transfer. Determine elements of a successful technology transfer. Why should you Attend: This presentation will introduce the concepts associated with implementing a carefully defined technical and business governance programs along with clearly defined R&D to site transfer steps for successful implementation.

Know the secrets to efficient Googling by attending this 90 minutes webinar. Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/Advanced-Googling-How-to-Stop-Searching-Like-a-Google-Zombie-and-Transform-Google-into-your-Backup-Brain-Robot-Assistant-and-Ambient-Sidekick-509338/AUGUST-2018-ES-TRAININGREGISTRY

Understanding the background behind SR Letter 11-7 and the purpose and scope behind the supervisory guidance on model risk management. Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/SR-Letter-11-7-Supervisory-Guidance-on-Model-Risk-Management-504944/AUGUST-2018-ES-TRAININGREGISTRY

Gain an understanding of how FDA is planning to give additional regulatory relief to its regulation of software, which has a startling change for premarket access. Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/Stunning-Changes-in-FDA-s-Software-Regulation-503201/JULY-2018-ES-TRAININGREGISTRY

Attend this webinar to know how to confidently prepare for and get a 510K approval from the FDA for your software enabled medical devices. Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/Medical-Device-Software-62304-Compliance-508708/JULY-2018-ES-TRAININGREGISTRY

This webinar give an understanding of software designing device for reliable and safe performance is critical for efficient business strategy. Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/Software-Validation-Testing-Regulatory-Requirements-505462/JUNE-2018-ES-TRAININGREGISTRY

This course is essential for medical device companies interested in submitting software enabled medical devices to the FDA for 510K approval. Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/Successful-510-k-Documentation-for-Software-or-Software-Containing-Medical-Devices-507429/MAY-2018-ES-TRAININGREGISTRY

This webinar provides initial guidance on how to build a cybersecurity recovery program that includes FDA CAPA elements. Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/Cybersecurity-Exploitation-Recovery-503341/MAY-2018-ES-TRAININGREGISTRY

In this webinar we will explain in detail the process of conducting a hazard analysis and how to integrate hazard analysis into the design program. Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/Hazard-Analysis-Following-ISO-14971-502071/APRIL-2018-ES-TRAININGREGISTRY

Anyone using Outlook needs to know there is a science to managing a digital office. In this webinar you will learn tips to finally get your digital correspondence under control.Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/Outlook-2016-Time-Saving-Tips-and-Tricks-505744/MARCH-2018-ES-TRAININGREGISTRY

Acceptance sampling plans are important tools for manufacturers. Effectively used they can help reduce costs while assuring quality and controlling risks. Unfortunately, this rich field of techniques is not as prominent as it once had been. As a result, quality practitioners don't always appreciate the wide range of available options or understand how to choose among alternate statistical sampling plans. Click to Continue Reading: https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901573SEMINAR?trainingregistry-April-2018-SEO

In every scrum project the product owner plays a vital role. First, by ensuring a clear communication of product or service functionality requirements to the Scrum team, and second, by delivering the product or the service to the stakeholders. This 2-day Scrum Product Owner Certification course helps participants attain skills required for a Product owner role including creating project vision, identifying and creating user personas and prioritizing product backlog items. This course offers comprehensive training for the SPOC™ examination. Participants will be awarded the ‘Scrum Product Owner Certified’ certificate after successful completion of the exam.

Overview: This course is NOT a programming course. We will discuss what must be done but will not discuss methods to execute necessary testing. Why should you Attend: Testing software to prove that it works and has no bugs is not sufficient to obtain FDA approval. There are additional requirements,analyses and tests that FDA feels are necessary to prevent user injuries.

Software's level of complexity and use is expanding at exponential levels. Likewise, the potential risks to health follow suit. Ransomeware attacks hold your software hostage until you pay hundreds or thousands of dollars. Life supporting and life sustaining healthcare grinds to a halt. Extracting personal healthcare information is another plague that has a huge financial incentive for hackers. Your software is running on thin ice. The FDA looks at software in one of three ways: Standalone, such as for a mobile app; device-based software used to control a device's performance, or simply electronic records. FDA's risk classification will gradually clarify keep enhancing: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901393SEMINAR?trainingregistry-January-2018-SEO

This course will present the procedures that must be used in the application of DOE and SPC to the development, design and monitoring of manufacturing and testing processes. A practical approach with case studies and examples will be used, with theoretical information introduced only when necessary to understand an experiment. Examples from real processes and testing procedures will be used to present the student with examples that will be directly applicable to their work. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901327SEMINAR?trainingregistry-November-2017-SEO

Overview: The first guidance document clarifies key terms and provides insight as to how a risk assessment can help medical device manufacturers to evaluate whether a new 510(k) is required. Examples of device changes and recommendations for documenting a company's decisions are provided. FDA provides a series of flowcharts and questions that can serve to guide medical device manufacturers to come to a conclusion as to whether a new 501(k) is necessary.

This webinar on FDA's design control requirements will discuss how a requirements management approach consistent with the CMMi requirements management KPA, helps companies meet FDA's design control requirements.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/COMPLIANCE-FDAs-DESIGN-CONTROL-504040/AUGUST-2017-ES-TRAININGREGISTRY