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Approval Training Seminars and Classes

From GlobalCompliancePanel

Importing and Exporting Medical Devices A Primer on Regulatory Strategy and Requirements - Webinar GlobalCompliancePanel Overview: Any medical device that is legally in the U. S. may be exported anywhere in the world without prior FDA notification or approval. The export provisions under section 802 of the FD&C Act only applies to unapproved devices. Devices that have not been approved or cleared in the U. S. must follow the export provisions of the FD&C Act. Thursday, May 17, 2012 10: 00 AM PDT | 01: 00 PM more...

Writing and Maintaining Quality Standard Operating Procedures SOPs to Guarantee FDA Compliance - Webinar By GlobalCompliancePane A cogent understanding and thorough knowledge of the regulations for SOPs is a necessity for product development and clinical testing organizations with the goal of agency approval, and product commercialization. Thursday, March 15, 2012 10: 00 AM PST | 01: 00 PM EST more...

Importing and Exporting Medical Devices A Primer on Regulatory Strategy and Requirements - Webinar By GlobalCompliancePanel Any medical device that is legally in the U. S. may be exported anywhere in the world without prior FDA notification or approval. The export provisions under section 802 of the FD&C Act only applies to unapproved devices. Thursday, March 8, 2012 10: 00 AM PST | 01: 00 PM EST more...

Change Control Management From Design to Commercialization - Webinar By GlobalCompliancePanel There is a need to implement an adequate formal level of change control during engineering projects (referred to as an Engineering Change Control) after the approval of the equipment/ systems specifications in addition to the more formal change control after the qualification of these systems. Thursday, January 12, 2012 10: 00 AM PST | 01: 00 PM EST more...

Master Production Record Requirement - Webinar By GlobalCompliancePanel This program will address the 21CFR and Eudralex Volume 4 requirements and interpretation, as well as FDA Guidance regarding the creation, review and approval, and control of Master Production Records. Tuesday, December 20, 2011 10: 00 AM PST | 01: 00 PM EST more...

New Amendments of Critical Parameters in Canadian Clinical Trials - Webinar By GlobalCompliancePanel ...the ethics process and how to get more quicker the ethics approval. Also after the presentation the participant will understand how to apply the last changes in ethics regulation in the day-to-day work. Every member of the study team and site staff participating in the clinical trial plays an important key role. Knowledge of ethics regulations will ensure quicker ethics approval, no audit more...

Document Approval Control and Distribution How to Meet FDA QSR and ISO 13485 Requirements in a Cost Effective Manner - Webinar B This webinar will provide valuable assistance to all regulated companies, since a CAPA program is a requirement across the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. more...

Designing Drafting Writing and Implementing The Quality Manual his webinar will begin with a brief discussion about quality then begin to explore how quality manuals have evolved into a communications device that assists all functions to reach their goals and objectives. It will demonstrate that the quality manual represents system for working together to achieve the organization's goals. You'll be shown that a quality system exceeds compliance more...

Requirements of validation and control of EO Sterilization - Webinar by global compliance panel Sterilization validation is a topic that results in many audit observations from the FDA and international regulatory bodies. more...

Validating Radiation Sterilization for Medical Device Industries by gcp Gamma and E-Beam radiation has used for sterilization of medical devices for over 50 years. Both methods are validated following the same principles and standards. This webinar will provide an overview of the requirements to validate medical devices for both Gamma and E-Beam sterilization. Validation is based on the international standard ISO 11137-1: 2006 and ISO 11137-2: 2006. In this one more...

Importing and Exporting Medical Devices A Primer on Regulatory Strategy and Requirements by GCP Any medical device that is legally in the U. S. may be exported anywhere in the world without prior FDA notification or approval. The export provisions under section 802 of the FD&C Act only applies to unapproved devices more...

Master Production Record Requirements - Webinar By GlobalCompliancePanel ...s well as FDA Guidance regarding the creation, review and approval, and control of Master Production Records. The material will enable attendees to establish a consistent approach to the design of MPR, including cover page content, instructions, processing requirements and limits, and signature expectations. (There will also be a note on Device Master Record.) In addition to learning what more...

Pharmaceutical and Medical Device Validation Guidances - Similarities and Differences - Webinar By GlobalCompliancePanel ...rences-Supplier and Component Consistency * Protocol Approval Process for Installation & Operational Qualification and Process Validation * Executing the Protocols * Reviewing the Issue Protocols, Taking Appropriate Actions, and Writing the Report * Revalidation Who Will Benefit: * Quality, quality control, regulatory, engineering, and manufacturing and IT staff more...

21 CFR Part 11 How to Successfully Prepare for and Host an FDA Inspection - Webinar By GlobalCompliancePanel ...ore needed and desired in each organization. In addition, approval of documents and records in a timely fashion is absolutely needed at all times, and being able to do just that via an electronic media is understood. For both, electronic signatures and electronic records, the organization shall comply with the Part 11 regulation. Areas Covered in the Session: * Short and quick more...

Requirements of the Master Production Record - Webinar By GlobalCompliancePanel ...s well as FDA Guidance regarding the creation, review and approval, and control of Master Production Records. The material will enable attendees to establish a consistent approach to the design of MPR, including cover page content, instructions, processing requirements and limits, and signature expectations. (There will also be a note on Device Master Record.) In addition to learning what is more...

Best Practices for the Implementation and Use of Test Management Tools - Webinar By GlobalCompliancePanel ...nically (in multiple systems) during development, review, approval and manually once the validation project is concluded. This practice lends itself to possible non-compliance due to human error, procedures not being properly followed and corruption of hard copy validation evidence. These issues are prompting life-science companies to search for ways to streamline and centralize their more...

A Comparison of the Pharmaceutical and Medical Device Good Manufacturing Practices - A Study of Similarities and Differences - W Overview: As a quality professional, you desire to have the very best quality system that operates effectively, efficiently and conforms to the appropriate quality standards to meet customer and user needs. You are also aware that there is a paradigm shift from an emphasis on compliance to an emphasis on quality based systems. An understanding of this paradigm shift can be gained by comparing more...

Elements of the Lot Disposition Process - Webinar By GlobalCompliancePanel ...rse will look at the creation of disposition packages for approval and rejection of materials, and cover changes in disposition status. The course will not cover the disposition of raw materials, third party (CMO) manufacturing, or validation lots. Why should you attend: The process for the disposition of product lots can be tedious and overwhelming. The requirements for intermediates, more...

Preparing for Pre-approval Inspections - Webinar By GlobalCompliancePanel ... at the end of the webinar. Why you should attend: Pre-approval inspections provides a relatively narrow window of time during which the NDA/ BLA/ ANDA holder can demonstrate to the FDA that the quality systems at the site are in compliance with the GMPs and that appropriate facilities are available to support manufacture of the product. It is therefore important to present the organization more...

Developing and Using the Product Risk Management FileReport - Webinar By GlobalCompliancePanel ...e FDA, to "toughen" its approach to product clearance and approval, while reducing liability issues. Why you should attend: The U. S. FDA has stated that the use of a medical device or pharmaceuticals entails some degree of risk. In fact, any medical procedure / intervention does. A manufacturer is responsible to identify those risks, and take reasonable steps to mitigate them as far as more...

Using Foreign Trial Data in Your NDA Approval Process - Webinar By GlobalCompliancePanel ...Approval Process training Webinar learn the guidance and regulations governing FDAa ™s acceptance of foreign trial data and know how FDA implementing these rule along with design considerations and requirements for foreign trials. Why you should attend: While the law allows 100 percent of pivotal data to come from foreign trials, there have been very few such submissions accepted by FDA more...

How to Prepare and Submit a Bullet Proof 510k and Latest FDA Proposed Changes to the Process - Webinar By GlobalCompliancePanel ... submit the 510(k) and what to expect with the review and approval process * When it is and is not required if you are a device company * Exemptions to the submission process and special considerations * How to locate a "predicate" device and go through the content and format of the 510(k) * Understand the De Novo process and the expectations for possibly marketing a low more...

FDAs Update on Medical Device Labeling Changes - Webinar by GlobalCompliancePanel ...ctions of labeling via a PMA supplement without prior FDA approval only when such modifications are based on newly acquired information and evidence of a causal association between the product and a safety signal is present. The rule also provides clarification as to what the Agency considers to be new information to be incorporated into a label change. Specifically, new information "must more...

Document Approval Control and Distribution How to Meet FDA QSR and ISO 13485 Requirements in a Cost Effective Manner - Webinar b Document control can be a time- and paper-consuming process. Even the simplest of changes often requires an inordinate amount of time spent in the preparation, submission, distribution, and implementation of change requests, document modifications, document review meetings, document approvals, and document placement. Many companies can spend MUCH LESS time and prepare MANY LESS documents, and more...

Secrets of an Effective CMC Regulatory Strategy for Biopharmaceuticals Part 1 - Cell Banking - Webinar by GlobalCompliancePanel Cell banking assures that an adequate supply of equivalent well-characterized cells exist for production over the expected lifetime of the biopharmaceutical. Cell line development followed by preparation of the master/ working cell banks is an expensive process and needs to be done right the first time. Cell banks acceptable for early clinical trial material production have been found not to more...

Managing the IDE Investigational Device Exemption Submission for Compliance Success - Webinar by GlobalCompliancePanel ...ty and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to FDA. Clinical studies are most often conducted to support a PMA. Only a small percentage of 510(k)'s require clinical data to support the application. Investigational use also includes clinical evaluation of certain modifications or new intended uses of more...

Importing and Exporting Medical Devices A Primer on Regulatory Strategy and Requirements ...d anywhere in the world without prior FDA notification or approval. The export provisions under section 802 of the FD&C Act only applies to unapproved devices. Devices that have not been approved or cleared in the U. S. must follow the export provisions of the FD&C Act. Foreign firms that manufacture medical devices and/ or products that emit radiation that are imported into the United States more...

From McCord and Associates

Creating a Career Changing Personal Marketing Plan Workshop Series

A true career changing marketing plan is a document that sets out in detail exactly the marketing channels that will be attacked and marketing methods that will be used; creates each marketing piece; identifies exact past history production percentages and ratios; makes projections based on past history; identifies problem areas and sets out a detailed plan to correct them; establishes objective more...

From Procept Associates Limited

PRINCE2 Foundation and Practitioner

...e role of a Project Board, and end-of-phase reporting and approval. It is not at all contrary to the processes described in the PMBOK ® Guide of the Project Management Institute. We recommend that organizations consider this approach to projects. As PRINCE2 ® is a very successful project management qualification, a large number of people and organisations have used and implemented more...

From Keen Info Solution

Oracle Financial R12 Online Training ...s (MRC) o Financial Statement Generator (FSG) o Journal Approval Process o Summary Accounts o Rollup Groups Budgets in General Ledger o What is Budget o Types of Budget o Setup Budget Controls o Setup Planning Budget o Setup Funding Budget o Apply Actual against Budget available o Apply Encumbrance against Budget available o Maintain Mass Budget o Apply Mass Allocation more...

Online Training for Oracle SCM R12 with 6y Real Time Expert ...eduling and Requests Defining Recounts, Adjustments, and Approvals Topics Covered During Session Overview of Oracle E-Business Suit process ORACLE AIM (Application Implementation Methodology) Overview of Documentations in Real-time Projects Over view of other Service Oriented modules Integrations ORACLE ORDER MANAGEMENT Order to Cash Lifecycle Ordering and Scheduling Process more...

Online Training for Oracle Financial R12 with 6y Real Time Expert

...s (MRC) o Financial Statement Generator (FSG) o Journal Approval Process o Summary Accounts o Rollup Groups Budgets in General Ledger o What is Budget o Types of Budget o Setup Budget Controls o Setup Planning Budget o Setup Funding Budget o Apply Actual against Budget available o Apply Encumbrance against Budget available o Maintain Mass Budget o Apply Mass more...

From Business Expert Webinars

Dogs are born to hunt. Is your sales staff born to sell? ...Some examples include - no fear of rejection, no need for approval, money motivated, positive outlook and many others. When a new hire lacks these traits, many frustrating hours of coaching and training will be wasted. The average cost of a hiring mistake in sales is over $100K; that includes hiring, training, management training not to mention lost sales and customers. This webinar defines more...