The international agreement to assemble all Quality, Safety and Efficacy information for a drug or biologic product into a common format (called the CTD - Common Technical Document) has improved the speed and efficiency for companies working in global development programs and clarified expectations by regulatory bodies. Reformatting for multiple submissions is substantially limited. The CTD has improved the regulatory review processes and enabled implementation of good review practices. The eCTD has increased efficiency for reviewers and improved submission times. Beginning in May 2017, the eCTD will be required in the US for all marketing applications.
Inspire and influence your team members to achieve your goals as a team!
Managers who will be promoted are the ones who not only manage efficiently but also lead their teams effectively. Learn how to work in a horizontal mode of operation…apply a consistent theory in leading your team…and teach critical leadership skills to members of your team, so each and every one of them can lead the team in your absence.
Today's workforce is experiencing high turnover and disengaged employees. It is a known fact that employees quit managers- to avoid turnover it is critical to have the appropriate skills to retain employees.
Transition from a Peer to Supervisor can be very difficult for most newly promoted supervisors. Many are not equip with the tools to successfully transition. This seminar will equip newly promoted supervisor with tools and techniques to decrease turnover, increase employee engagement and increase employee productivity.
When new drugs or devices are tested in humans, the data generated by, and related to, these trials are known as clinical data. This data represents a huge investment by the biopharmaceutical or device company and is one of its greatest assets. It is this data that will eventually make a new product both useful as a treatment or therapy and marketable.
The management of clinical data, from its collection during a trial to its extraction for analysis, has become a critical element in the steps to prepare a regulatory submission and to obtain approval to market a treatment. As its importance has grown, clinical data management (CDM) has changed from an essentially clerical task in the late 1970s and early 1980s to the highly computerized specialty it is today.
Attend this training to understand the definition of combination products and determine the required regulations from FDA.
Price:$229.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 firstname.lastname@example.org Event link -
This webinar will walk you through step-by-step how to complete a DIOM for your product and simplify this often overly complex process, This webinar provides a simplistic tool to help identify and categorize design inputs, determine the most effective method in providing design output evidence, and showing traceability to all activities associated with both.
This webinar will discuss the techniques for controlling and managing High Risk Transaction. The Instructor will discuss the parameters for identifying and qualifying transactions as high risk and process and communication to be followed. He will also discuss how to resolve the end result.
The document management system for medical device industry should help companies have control over critical activities such as:
Establishing best practice SOP, Deviation, CAPA, Change Controls, Complaint and Audit processes
Conducting Risk Assessment, Root Cause Analysis and Impact Assessment where appropriate
Creating Action Plans, and verifying their effectiveness
Improving efficiencies over the QMS tasks
Reducing the risks of manual error
Ensuring compliance to 21 CFR Part 11 and immutable audit trail
Avoid observations, 483 letters and fines
Taking the resource burden out of creating dashboards/ periodic reports
This one-day course is for technical personnel involved in the sizing, selection and operation of Pumps in Oil and Gas Processing facilities. The course focuses on the hydraulic principles of centrifugal pumps, their sizing and system design. You will learn quick pump calculations for conceptual studies along with rules of thumb as well as rigorous calculation required during detailed engineering phase.
This course is tailored for individuals who have some pump basic knowledge and/or are seeking a deeper understanding of how centrifugal pumps work, and when and how to apply this knowledge. This course benefits those who are involved in some facet of pump design or application.
Technicians, Operators and Junior Engineers will find this course especially helpful and relevant.
This one day course will cover three principal aspects of overpressure protection. Firstly the regulatory requirements that must be met in Alberta. Secondly the many ways in which overpressure can occur. Thirdly the ways to mitigate against overpressure. Topics such as relief scenarios, ABSA, ASME, double contingency together with an in depth review of relief device types and sizing will be covered. Examples of relief scenarios and calculations to size relief devices will be included.
This course will benefit designers of facilities, operators of these facilities and process safety personnel.
The purpose of this seminar is to increase the skill and knowledge of Engineers, managers and operators in Technical Safety BC, and Safety Code requirements in British Columbia Oil and Gas industries.
The overall objective of this seminar is to give students a background in:
1. Technical Safety BC requirement for Design, Fabrication, Construction, Welding, Inspection, In-service Inspection of Pressure Equipment.
2. Interfaces between Technical Safety BC and OGC (British Columbia Oil and Gas Commission)
The purpose of this seminar is to increase the skill and knowledge of Engineers, Managers and Operators in ABSA (Alberta Boilers Safety Association), and Safety Code requirements in Alberta Oil and Gas industries.
The overall objective of this seminar is to give students a background in:
1. ABSA requirements for Design, Fabrication, Construction, Welding, Inspection, In-service Inspection of Pressure Equipment.
2. Interfaces between ABSA and AER (Alberta Energy Regulator)
A complete set of course materials is included in the ABSA Requirements From Design to Operation course.
This highly interactive one-day course is designed for leaders, team members, and anyone who needs to assess risk and make decisions. Too often these two activities are based on subjective bias and not objective facts. This course will discuss the bias that we all have and present methods to assess risk and make decisions as a team with minimal bias to obtain the best possible results.
The methods of facilitated risk assessment using risk matrices and fault tree analysis will be explained and both methods practiced in the classroom.
A structured and quantified method of making decisions will be taught and practiced based on the Kepner Tregoe Method.
In this presentation we will show how SPC can have a major impact on our businesses if we start using it as a managerial tool, Statistical Process Control (SPC) is one of the fundamental techniques in quality management, And This webinar will show you why and what you can do about it, The purpose is no longer to control a technical process but to manage your business processes in a much better way.
The FDA has instigated a Refuse to Accept Policy and will no longer accept 510K submissions that do not meet a minimum threshold of acceptability. By doing so, the Center for Devices and Radiological Health, will be able to focus substantive review on submissions that are complete. It is expected that 510(K)s that are accepted under this new policy, will be reviewed more quickly.
This webinar will review GMP requirements for complaint handling. We will also discuss the types of complaints (adverse and non-adverse events) that may be received.
You will learn about the key components in managing complaints such as tracking the complaint from time of receipt to completion, initiating and performing a complaint investigation, evaluating the complaint for medical device reporting, final review of the complaint and investigation and preparing a response to the complainant.
Too often Project Leaders and Managers fall into the role due to demonstrated technical competence. After all, if you're competent enough to create great technical output, certainly you can figure out how to run a project on schedule and within budget, right? And even when you get an opportunity to attend training to become a better Project Manager, the focus is on the "hard" or technical aspects of project management rather than the "soft" skills or habits that typically only come with experience.
This webinar will examine the changing focus of medical device regulation, similarities and differences between ISO 13485 and 21 CFR 820 (FDA's Device CGMPs), We will establish the correct definition of "risk", tied to ISO 14971 which has led to some major issues with companies selling to both the US and the EU.
Several trends will influence business. For this presentation we are looking at three specific ones, and their impact on quality management and quality tools. The first trend is digitization, not just of business processes but also of society at large.
A second trend is speed of change and reduced product life cycle time and linked to this a reduced time to improve a product after it has been released to the market. The third trend is the continuous increase of intelligent automation through Artificial Intelligence (AI) and self-learning systems.
This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA regulated companies and how conformance to Part 11 differs from just having good IT security. Procedures for controlling electronic signatures and electronic records as described in the FDA Guidance will be explained.
FDA regulated companies want to transition to electronic records for economy and efficiency. FDA, because of its concern for patient safety, wants to prevent electronic records from being compromised with possible resulting harm to the patient. FDA has set up regulations that address both data security and patient safety. We will show how 21 CFR part 11 considers both.