Associated Web-based Seminars

ITIL v3 Service Offerings and Agreements Capability SOA ...ects of the ITIL ® v3 Service Lifecycle and processes associated with the Service Offerings and Agreements of services and service delivery. The main focus of this course is on the operational-level process activities and supporting methods and approaches to executing these processes in a practical, hands-on learning environment. This training is intended to enable the holders of the  more...

ITIL v3 Operation Support and Analysis Capability OSA ...ects of the ITIL ® v3 Service Lifecycle and processes associated with the Operational Support and Analysis of services and service delivery. The main focus of this course is on the operational-level process activities and supporting methods and approaches to executing these processes in a practical, hands-on learning environment. This training is intended to enable the holders of the  more...

ITIL v3 Planning Protection and Optimization Capability PPO ...ects of the ITIL ® v3 Service Lifecycle and processes associated with the Planning Protection and Optimization of services and service delivery. The main focus of this course is on the operational-level process activities and supporting methods and approaches to executing these processes in a practical, hands-on learning environment. This training is intended to enable the holders of the  more...

ITIL v3 Release Control and Validation Capability RCV ...ects of the ITIL ® v3 Service Lifecycle and processes associated with the Release, Control and Validation of services and service delivery. The main focus of this course is on the operational-level process activities and supporting methods and approaches to executing these processes in a practical, hands-on learning environment. This training is intended to enable the holders of the  more...

ITIL v3 Service Transition Lifecycle Course ... in the overall concepts, processes, policies and methods associated with the Service Transition phase of the Service Lifecycle. The course covers the management and control of the activities and techniques within the Service Transition stage, but not the detail of each of the supporting processes. This course is designed using an engaging scenario-based approach to learning the core  more...

Power of Persuasive Proposals ...proposals doesna ™t look anything like whata ™s associated with all the negatives of selling: a superficial snow job slathered in adjectives. Ironically, the same people who despise sales, use the techniques that come across as cheesy sales when they start proposals with the tired a We are pleased to submita and continue to beat the chest of the bidder on how they are a world  more...

Early Intervention Field Trauma Training ...dge and skills needed to respond to the emotional trauma associated with natural or human-caused disasters or crisis. Topics include warning signs, recovery stages, fitting interventions to client needs, the new Educate, Assess and Refer (EAR) Field Trauma Response model, Reactions and Response to CBRN Terrorism, steps to lessen crisis impact, utilization of community resources for  more...

RAPS Approved Seminar on Risk Management in Pharmaceutical Industry at Mumbai ...een designed to address the processes, methods, and tools associated with Quality Risk Management. It highlights the disciplined environment that is necessary for proactive decision making to continuously assess what risks a organization is exposed to, which risks are important to deal with and how the implementation of strategies can mitigate risks. Additionally, the course provides trainees  more...

The Drug Development Process - From RD to Commercialization - Webinar By GlobalCompliancePanel In today's fast-paced, highly regulated and risk-aversive environment, functional groups can no longer work in isolation, but must collaborate extensively to design, develop, manufacture, test, validate and commercialize new drugs. Successful commercialization depends on effective processes to bring both the drug supply manufacturing processes and controls as well as the associated data and  more...

Pharmaceutical and Medical Device Validation Guidances - Similarities and Differences - Webinar By GlobalCompliancePanel Overview: This webinar will provide an overview of process validation for devices and pharmaceuticals. While most of the webinar will include FDA compliance requirements, there will be some International Standards Organization (ISO), European, and Canadian regulations included for exploration. After attending this webinar, attendees will have a greater perspective of process validation and its  more...

Auditing an Active Pharmaceutical Ingredient API Contract Manufacturing Organization CMO - Webinar By GlobalCompliancePanel ... that is gained through exposure to the unique attributes associated with API manufacturing. API manufacturing has similar regulatory GMP expectations as drug products, but not identical in is specific requirements and application. The nature of API manufacturing and its usual purification processes all influence how an API process should operate. Knowing what the FDA expects and how these  more...

Internal 21CFR Part 11 Compliance Auditing of Computer Systems - Webinar By GlobalCompliancePanel ...ice, Diagnostic, Pharmaceutical, and Biologics fields and associated vendors such as contract research, manufacturing, testing and systems. This presentation will describe a proven process for preparing a site for inspection of systems. Case studies will be used to illustrate how this process has successfully prepared several pharmaceutical companies to answer this question accurately,  more...

Understanding Attribute Acceptance Sampling including Z14 and c0 Plans -- Webinar By GlobalCompliancePanel ...e it is cost effective. She also knows there is some risk associated with sampling, but she admits she doesna ™t completely understand it. You now have a new assignment; assure your manager that you have good balance between risk and cost. The person who set up the system retired a few years ago and isna ™t available to help. You have also heard about some new methods called c=0 or  more...

FDAs New Process Validation Guidance - Webinar By GlobalCompliancePanel ...gement, statistical controls, and GMP requirements * Associated and predicate testing, qualifications, and vaildations * Analytical and recordkeeping expectations * Opportunity for accelerated release of commercial product * Differences between the old and new standards, and the draft and final Who Will Benefit: * Validation specialist * Validation engineer  more...

Cleanroom HEPA Filter Testing Certification An Owners Guide - Webinar by GlobalCompliancePanel ...ing and discussing testing and certification requirements associated with cleanrooms. The key benefits of this course are: * In-dept understanding of industry standards, processes, and criteria for testing cleanrooms and HEPA filters * Achieve satisfactory inspections more easily * Higher assurance of new medical product approvals * Minimize nonconformances *  more...

Understanding the Technical Requirements of 21 CFR Part 11 - Webinar by GlobalCompliancePanel ... Due to serious inefficiencies and non-conformance issues associated with trying to address Part 11 late in the system lifecycle, it is important to give the technical requirements due consideration early in the process. A good understanding of these technical requirements is paramount to avoiding the syndrome of "testing into compliance" later on. Often, the compliance status of a system can  more...

Preparing for GFSI and other Third Party Audits - Webinar By GlobalCompliancePanel .... Many organizations are new to the process of audits and associated standards. Thus, they are seeking out expensive consultations and/ or are requesting pre-assessments to prepare for audits. In order to work cost effectively, allocating resources and dollars to professional help with developing better systems rather than simply reviewing current programs, the supplier will be given the tools  more...

Operational Risk Management Ensuring Safety for Food Systems - Webinar By GlobalCompliancePanel ...s controls over food safety and security, the liabilities associated with recalls and deaths are creating new approaches to determine and reduce the likelihood of risks associated with contaminated foods. Risk assessment involves determining where and what types of risks are involved throughout any food process, assigning quantitative values to those risks, measuring the processes based on  more...

Analytical Instrument and Equipment Qualification in Quality Laboratories - Webinar By GlobalCompliancePanel Overview: The analytical instruments and equipment used in GXP laboratories must be calibrated and qualified for use in regulated testing. This includes quality control labs attached to cGMP facilities, GLP labs supporting animal toxicology studies and GCP labs supporting clinical trials. Additionally, labs supporting EPA studies are also regulated. This seminar will review the regulations that  more...

Designing and Implementing the Quality System for Combination Products - Webinar By GlobalCompliancePanel .... This course looks at these principles and the processes associated with each principal to design, implement, and maintain a combination system that surpasses compliance requirements. The seminar will focus primarily on the principles embodied in CFR Parts 210-211 and ICH Q7A for pharmaceuticals and Part 820 for medical devices as well as pertinent passages of the International Conference on  more...

How to Prepare and Submit a Bullet Proof 510k and Latest FDA Proposed Changes to the Process - Webinar By GlobalCompliancePanel ...ons * 510(k) Submission Methods * List of forms associated with Premarket Notification 510(k) submissions * Deciding When to Submit a 510(k) for a Change to an Existing Device * What happens if FDA requires additional information and data and your responsibilities Interactive Q&A, Wrap-Up and Adjourn * Q&A with all attendees * Group discussion and review of  more...

Construct and Manage the Technical File and Design Dossier - Webinar By GlobalCompliancePanel ...entry. Whereas the expression "Technical File" is usually associated with Class I, IIa and IIb, and "Design Dossier" for class III products., the files are retained on the premises of the manufacturer or the Authorized Representative for potential review of Competent Authorities and Notified Body. Dossiers have to be submitted to the Notified Body for review prior CE-Marking of your product. It  more...

The Drug Development Path - From RD to Commercialization - Webinar By GlobalCompliancePanel An overview of the drug development process, reviewing key deliverables for each stage of the development path with a special focus on managing the development process when using external resources such as Contract Manufactures, Contract Testing Labs and Contract Research Organizations. In today's fast-paced, highly regulated and risk-aversive environment, functional groups can no longer work  more...

Full Day Virtual Seminar - Designing and Implementing the Quality System for Combination Products - by GlobalCompliancePanel .... This course looks at these principles and the processes associated with each principal to design, implement, and maintain a combination system that surpasses compliance requirements. The seminar will focus primarily on the principles embodied in CFR Parts 210-211 and ICH Q7A for pharmaceuticals and Part 820 for medical devices as well as pertinent passages of the International Conference on  more...

Full Day Virtual Seminar - Reduce Software Validation Costs and Pass the New 21 CFR Part 11 Inspections - Webinar by GlobalCompl ...s interactive one-day seminar details how to reduce costs associated with implementing, using, and maintaining computer systems in regulated environments. Nearly every computerized system used in laboratory, clinical, manufacturing and the quality process has to be validated. Participants will learn the latest techniques for complying with 21 CFR Part 11 that greatly reduce software  more...

ICH Q7 Guidelines and Practical Approaches to Manufacturing APIs - Webinar by GlobalCompliancePanel ...by the ICH Q7 Guidance. The international supply chain associated with API manufacturing was one of the greatest drivers for the development and international adoption of these expectations by regulators world-wide. The growth in the number of FDA inspections of API producers outside of the USA also played a major role in motivating international interest in the development of a "universal"  more...

Using SLAs to Facilitate Enterprise and IT Governance Risk Management and Compliance GRC - Webinar by GlobalCompliancePanel This one-of-kind webinar is intended to provide you with practical guidelines on applying SLA concepts to your organization's GRC program. Organizations that have SLAs for GRC reap these benefits: * Ongoing improvements in their ability to identify, assess and prioritize risks * facilitates business owners involvement in risk management and GRC programs that affect them *  more...

Effective Essential CAPA process to avoid FDA 483 - Webinar by GlobalCompliancePanel ...ne what we mean by risk. We will then explore the factors associated with risk in compliance. We will also explore risk causing events and how to address them. A review of risk severity/ level will then ensue. Upon completion of risk part of the presentation we will define what a CA/ PA system would look like. Finally an overview of a CA/ PA system will be presented and a CA/ PA approach will  more...

Failure Modes and Effects Analysis FMEA - An Effective Tool for Medical Device Risk Management - Compliance Webinar by GlobalCom The presentation will discuss the proper use of FMEA in risk management and how to recognize and avoid the traps associated with this tool in order to have a more efficient risk management process.  more...

ITIL Foundation Bridge Virtual Classroom Take the ITIL ® v3 Foundation Bridge course Virtual Classroom is set up in the same manner as the physical classroom however altered to optimize the virtual learning experience without the hassle of travel. The virtual classroom delivery option is ideal for training geographically dispersed teams. This 2-day course introduces learners to the lifecycle of managing IT services to deliver to  more...

ITIL v3 Foundation Virtual Classroom Take the ITIL ® v3 Foundation course Virtual Classroom is set up in the same manner as the physical classroom however altered to optimize the virtual learning experience without the hassle of travel. The virtual classroom delivery option is ideal for training geographically dispersed teams. This exciting and dynamic 3-day course introduces learners to the lifecycle of managing IT services  more...

Records Management 4 - Records Management Software - On-Demand Webinar ...nd reduce a lot of the more tedious, time consuming tasks associated with managing information. It will also cover the range of software options and how to develop and manage the process for developing system requirements and choosing the right solution. Michael Oa ™Shea has been involved in Records and Information Management consulting for over 20 years. He is one of the most respected  more...

Tax Lien Investing Webinar- Series I Gain a clear understanding of the advantages and risks associated with real estate tax liens and/ or real estate tax deeds with expert help from Howard Liggett during this 90-minute online Webinar training presentation. He will discuss the ins-and outs of tax sale investing, including key differences between tax liens and tax deeds.  more...