All Conferences

Overview: The focus will be on drugs, biologics and medical devices, We will also be providing an overview of how the regulatory landscape is currently evolving for most efficient strategic planning. Why should you Attend: This webinar will give you a snap shot of what is current, what is coming and what this means to anyone who is currently developing Drugs and other Health Products for the Canadian market. The focus will be on drugs, biologics and medical devices. Areas Covered in the Session: Current regulatory & submission requirements for drugs, biologics and medical devices as required by Canada's Regulatory…

Overview: These may be used for GxP regulated activities, and they present particular compliance challenges, as Excel and other spreadsheets are not originally designed for the regulated environment. Why should you Attend: Part 11 / Annex 11 Computer Systems Validation (CSV) is to be implemented in order to increase the integrity, accountability and security of the spreadsheets and achieve GxP Compliance. Areas Covered in the Session: Types and Uses of Excel Spreadsheets Computer Systems Validation for Excel Examples of Typical Approaches for Excel Validation Who Will Benefit: Validation Specialists Database Administrators System Administrators Document Managers Training Managers Regulators Speaker Profile:…

Overview: Sponsors or consultants auditing labs on behalf of a pharmaceutical or biopharmaceutical company need strong tools for preparing and conducting audits.Careful consideration of the work that will be performed at the laboratory provides a working framework for the content of the audit. Why should you Attend: Auditing vendors is an essential function for quality and scientific personnel. Training and clarification of the process necessary for good audits is important for Sponsors gathering the necessary information to qualify a vendor laboratory or to document that procedures are following standard expectations of GMP and GLP. Areas Covered in the Session: Assessments…

Overview: How does the new standard impact laboratories that are already accredited and how do you ensure staff adherence and ongoing compliance to minimize corrective actions arising from accreditation audits? Why should you Attend: What are the changes to the technical and management requirements and how should these be addressed? This webinar will discuss the old as well as the new changes in the standard and their impact on your QMS. Areas Covered in the Session: Handling of customer items Technical records Evaluation of uncertainty of measurement Validity of results Reporting of results Who Will Benefit: Laboratory Managers QA Managers…

Overview: FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based company-wide V&V planning. Why should you Attend: Verification and validation requirements have always been part of the US FDA's GMPs.However, with increasing technology, both industry and regulatory agencies expectations have increased. Areas Covered in the Session: The 11 key documents for software validation Incorporating 21 CFR Part 11 requirements Suggested "test case" formats Who Will Benefit: Supplements QA RA R&D Engineering Production Operations Speaker Profile: John E. Lincoln is a medical device and regulatory affairs…

Overview: This course will outline the issues that need to be considered in the preparing to respond to disasters, and will suggest ways to minimize impact to the business and to maintain consumer safety. Why should you Attend: Consumer Safety is paramount in the food industry, which an industry that is heavily regulated by domestic and international authorities such as the FDA, EPA etc. Areas Covered in the Session: Discuss the different types of Disasters Understand the important aspects of recovering from a disaster Understand the important aspects of business continuity Who Will Benefit: Manufacture Retail Operations Export / Import…

Overview: Grab a cup of coffee and join us to learn how to analyze the numbers, and use this intel to juice up virtually every facet of your organization's operations from marketing, to finance, to HR, to customer service and sales. Why should you Attend: Accounting and finance is supposed to be the international language of business. If so, then why do we struggle so much to make sense of the numbers? Areas Covered in the Session: Use the annual report to perform a fundamental financial analysis Learn the various types of financial analysis and their purpose Learn the key…

Overview: Yet GMPs have been enshrined into law for many countries and a drug/biologic/medical device manufacturer should have a reasonable expectation of all inspections being the same. Why should you Attend: This webinar will cover the key areas of how ICH Q7 was established, it's goals and objectives, expectations of the healthcare authorities involved and practical differences that you will experience in a GMP inspection of a facility by FDA, an EU Competent Authority or PMDA. Areas Covered in the Session: Where Inconsistencies Become a Problem: WHO, ICH, Countries Discrepancies in global expectations Alignment issues Key Chapter Reviews ICH GMP…

OVERVIEW HIPAA webinars, discussions, and presentations are usually addressed from the perspective of what the HIPAA regulations entail, the necessity of compliance with the regulations, and the consequences of HIPAA violations, willful neglect or non-compliance. This presentation addresses HIPAA regulations from a different perspective — from a personal perspective — from the perspective of the person in charge of moving an organization or facility toward full compliance with HIPAA. The by-product of this presentation will be both an understanding of, and a detailed job description for, a position mandated in the regulations — the HIPAA Security/Privacy Officer. WHY SHOULD YOU…

Overview: Biologics, as well as small molecule pharmaceutical products, require expiry dating.The complex structure of large molecules presents greater opportunities for degradation. Biologics may lose identity by cleavage ultimately resulting in loss of potency. Why should you Attend: To collect data that supports expiry dating, the drug substance and the drug product must be thoroughly tested in stability indicating methods. Understanding the importance of these methods and the analysis and interpretation of the data is necessary for personnel involved in product development, product testing, and product release. Areas Covered in the Session: Testing CQAs Stability Indicating Methods Test conditions, including…

“Advances in collaborative research for public health, medical and medicine sciences for better healthcare services to society” The conference will cover vital issues in medical, medicine and health sciences under multiple sub-themes. The aim of our conference is to support, encourage and provide a platform for networking, sharing, publishing and nurturing the potential growth of individual scholars across the globe.

“Advances in collaborative research for public health, medical and medicine sciences for better healthcare services to society” The conference will cover vital issues in medical, medicine and health sciences under multiple sub-themes. The aim of our conference is to support, encourage and provide a platform for networking, sharing, publishing and nurturing the potential growth of individual scholars across the globe.

“Advances in collaborative research for public health, medical and medicine sciences for better healthcare services to society” The conference will cover vital issues in medical, medicine and health sciences under multiple sub-themes. The aim of our conference is to support, encourage and provide a platform for networking, sharing, publishing and nurturing the potential growth of individual scholars across the globe.

“Advances in collaborative research for public health, medical and medicine sciences for better healthcare services to society” The conference will cover vital issues in medical, medicine and health sciences under multiple sub-themes. The aim of our conference is to support, encourage and provide a platform for networking, sharing, publishing and nurturing the potential growth of individual scholars across the globe.

Advance Technology & Engineering Network (ATEN) aims to bring together leading academician scientists, researchers and research scholars to exchange and share their experiences and research findings about various aspects of Engineering and applied Sciences. It also provides the premier interdisciplinary forum for scientists, engineers, and practitioners to present their latest research results, ideas, developments, and applications in all areas of Engineering and Natural Sciences.

ATEN as a scientific institution aims to focus on current advances in the research, production and use of Engineering and applied Sciences with particular focus on their role in maintaining academic excellence in Engineering and Applied Sciences.

Advance Technology & Engineering Network (ATEN) aims to bring together leading academician scientists, researchers and research scholars to exchange and share their experiences and research findings about various aspects of Engineering and applied Sciences. It also provides the premier interdisciplinary forum for scientists, engineers, and practitioners to present their latest research results, ideas, developments, and applications in all areas of Engineering and Natural Sciences.

Advance Technology & Engineering Network (ATEN) aims to bring together leading academician scientists, researchers and research scholars to exchange and share their experiences and research findings about various aspects of Engineering and applied Sciences. It also provides the premier interdisciplinary forum for scientists, engineers, and practitioners to present their latest research results, ideas, developments, and applications in all areas of Engineering and Natural Sciences.

International Conference on recent Trends in Engineering , Network, Communication, and Applied Sciences provides lots of networking opportunities to scholars professors and Practitioners for corporate and development sectors. The scope of this conference is broad and covers many aspects of international technology perspectives. This conference aims to provide scholarly platform to participants to share their valuable knowledge and current information with others.

International Conference on recent Trends in Engineering , Network, Communication, and Applied Sciences provides lots of networking opportunities to scholars professors and Practitioners for corporate and development sectors. The scope of this conference is broad and covers many aspects of international technology perspectives. This conference aims to provide scholarly platform to participants to share their valuable knowledge and current information with others.