Considerations Web-based Seminars

Managing Business Risk ...ourse will help students identify special risk-management considerations for specific types of businesses and industries. It will also help students develop a strategic approach to risk, which, when understood across the organization, with commitment at the very highest level, can enhance a company ' s competitive advantage and contribute to the company ' s value. The open, modular-style manual  more...

Reusable Device Cleaning Disinfection and Sterilization Validations Overview and Key Design Considerations for Device Engineers Validation of reusable medical devices requires that the manufacturer develop methods for cleaning (after use) washing to remove all foreign matter possibly disinfecting and repackaging for the next use. The diversity of medical devices their intended use and classification in accordance with the food and drug administration requires that the manufacturer develop and validate the reprocessing  more...

Dietary Supplement Regulatory Compliance in the United States Labeling Product Claims Updates from the FDA - Webinar By GlobalC ... cover what qualifies a material as a dietary ingredient, considerations for manufacturers and distributors, requirements for compliant labeling and acceptable marketing claims. An update on FDAa ™s draft guidance for New Dietary Ingredients and an overview of the Dietary Supplement Labeling Act (both introduced in 2011) will also be discussed. At the conclusion of this 75 minute  more...

A Simpler Approach to Implementing or Validating CGMPs to 21 CFR 11 Electronic Records Signatures - Webinar By GlobalComplianceP The verification and validation of electronic records and electronic signature software is coming under increased scrutiny by the U. S. FDA. This webinar will address the use of FDA Guidance's, GAMP, 21 CFR Part 11, "Electronic Records" / "Electronic Signatures", and other applicable industry software validation models, coupled with the ISO 14971 / ICH Q9 Product Risk Management models, to  more...

Valuing and Understanding Diversity in the Workplace Today by TrainHR ...cover areas of sensitivity and inclusion as well as legal considerations for protected classes and the business case for diversity. We will explore assumptions, beliefs, generalities, discrimination, prejudice, perception, and stereotypes. We will cover changing demographics and top growth groups, generational diversity, gender differences, and the differences in personality profiles. Our  more...

Bullying in the Workplace by TrainHR ...cover areas of sensitivity and inclusion as well as legal considerations for protected classes and the business case for diversity. We will explore assumptions, beliefs, generalities, discrimination, prejudice, perception, and stereotypes. We will cover changing demographics and top growth groups, generational diversity, gender differences, and the differences in personality profiles. Our  more...

Device Changes and the 510k - Webinar By GlobalCompliancePanel The majority of medical devices are cleared for marketing in the U. S. by the FDA under the 510(k) process. The FDA holds companies responsible for filing new 510(k)s when one change is major enough to impact safety / effectiveness, or when a series of lesser changes finally reach the "tipping point". This is a major headache. How can companies make that determination? How can they trigger such  more...

Develop and Execute the Company Software VV Program - Webinar By GlobalCompliancePanel ...DQ, IQ, OQ, PQ (or their equivalents) * GAMP / Other Considerations * The FDA's 11 Key V&V Documentation Elements * "White Box" and "Black Box" Validations Who will benefit: * Senior management in Drugs, Devices, Biologics, Dietary Supplements * QA * RA * R&D * Engineering * Production * Operations * Consultants; others tasked with  more...

Best Practices for the Implementation and Use of Test Management Tools - Webinar By GlobalCompliancePanel ...ions, System Maintenance, Training and Testing Automation considerations. Why should you attend: This webinar will address the benefits of implementing a Test Management Tool to manage the validation life cycle, considerations for the implementation project of a Test Management Tool, Test Management Tool Operation/ Maintenance requirements and Automated Testing considerations. Areas  more...

Recruiting is Critical to Your Success What is the Secret - Webinar By GlobalCompliancePanel ... regulatory / legal responsibilities and also the ethical considerations in pharmaceutical product (Drug or device) research involving human subjects. Those benefiting the most would be: * Principal Investigators and sub investigators * Clinical Research Scientists (PKs, Biostatisticians, ...) * Safety Nurses * Clinical Research Associates (CRAs) and Coordinators (CRCs)  more...

Understanding the Technical Requirements of 21 CFR Part 11 - Webinar by GlobalCompliancePanel ...his session will provide a focus on understanding the key considerations for the technical requirements of Part 11, to ensure system are compliant from a Part 11 technical perspective and, when coupled with sufficient procedural controls, will result in an overall Part 11 compliant deployment. Why should you attend: With the announcement in 2010 of a new Part 11 Inspection initiative, life  more...

Effective Training Practices for FDA Compliance - Webinar By GlobalCompliancePanel ... system, including types of training planning, will offer considerations to make GMP training more effective. Why you should attend: Regulatory agencies around the world require that training on good manufacturing practices (GMP) be conducted on a regular basis for those who are involved in producing pharmaceutical and biological products. Documentation is also needed as evidence that the  more...

Using Foreign Trial Data in Your NDA Approval Process - Webinar By GlobalCompliancePanel ...nd 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 - mainly in limited therapeutic areas. Given lower costs and shorter recruiting times, the use of foreign sites is appealing  more...

How to Prepare and Submit a Bullet Proof 510k and Latest FDA Proposed Changes to the Process - Webinar By GlobalCompliancePanel ...y * 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 risk device * Understand the potential impact of FDA's proposed changes to the 510(k) process and why manufacturers need to pay attention  more...

Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences - Part I and Part II - Webinar By GlobalCompli ...od Sanitation Council) o Patents and Trademark Considerations * Beginning Your Company Involvement in Japan o Local Office and Personnel Requirement Options o Language Requirements o Possible License Types * Objectives of the Rules Governing Medicinal Procedures o Market Authorization Holder Overview * Life Science  more...

Navigating Pediatric Trials from recruitment to successful on-time completion - Webinar by GlobalCompliancePanel Drug companies face many challenges in pediatric clinical research. Pediatric trials come with a high level of complexity and cost. In order for professionals to carry out a successful pediatric drug development plan, they need the right infrastructure and information to avoid obstacles such as slow recruitment, noncompliance and difficulties in developing the right study criteria and protocol.  more...

Complete Java Training ...ls() and hashCode() o Caching and Efficiency o Design Considerations Spring Framwork Training * Spring Modules Introduction o Web Applications o Persistence Support o Aspect-Oriented Programming o Integrating Other Frameworks * Core Techniques o JavaBeans, o Factory Pattern o Inversion of Control o XML View: Declaring Beans o Singletons and Prototypes o Bean  more...