Conferences - Calls for Papers

Listings
  • Internal Auditing to MDSAP: Concepts and Practices in Aligning the Internal Audit Program

    Internal Auditing to MDSAP: Concepts and Practices in Aligning the Internal Audit Program

    Medical Sciences san Jose (california) October 29, 2020 Check with publisher

    This course will give an introduction into the Medical Device Single Audit Program (MDSAP) and how to adjust your internal audit program. The introduction will give an overview about the requirements for the quality management system and how to condu...

  • Attaining Your CE Mark for Your Medical Device in the EU

    Attaining Your CE Mark for Your Medical Device in the EU

    Medical Sciences san Jose (california) October 28, 2020 Check with publisher

    If you manufacture products for the EEA it is imperative that you know and understand the regulations that govern the CE marking process particularly in light of the new EU medical device regulation. Manufacturers, distributors, and importers all hav...

  • Root Cause Analysis - Starting at the Beginning

    Root Cause Analysis - Starting at the Beginning

    Medical Sciences Fremont (California) October 22, 2020 Check with publisher

    Overview: CAPA and the related actions of Failure Investigation and Root Cause Analysis (RCA) is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities. A co...

  • Secrets to Writing Effective SOPs for Medical Device QMS

    Secrets to Writing Effective SOPs for Medical Device QMS

    Medical Sciences Fremont (California) October 22, 2020 Check with publisher

    Overview: Standard Operating Procedures (SOPs) are a critical ingredient in an effective and efficient Quality Management System. SOPs are typically one of the first things an investigator asks for in an inspection. Well written SOPs send a message t...

  • Validation Challenges for Bioassays

    Validation Challenges for Bioassays

    Medical Sciences Fremont (California) October 22, 2020 Check with publisher

    Overview: Validation of test methods is a critical requirement for the drug development process. Bioassays are used to support biologics in the drug development process and in post-market analytical support. Unlike analytical test methods for small m...

  • Design History Files (DHF), Device Master Records (DMR)

    Design History Files (DHF), Device Master Records (DMR)

    Medical Sciences Fremont (California) October 22, 2020 Check with publisher

    Overview: It will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be...

  • Expedite Excel with Hidden Shortcuts

    Expedite Excel with Hidden Shortcuts

    Medical Sciences Fremont (California) October 22, 2020 Check with publisher

    Overview: Excel expert David Ringstrom, CPA is fond of stating "Either you work Excel, or it works you!" In this fast-paced presentation David will share over two dozen ways that you can reclaim part of your day from Excel. You'll uncover mouse techn...

  • Enzyme Activity Measurement

    Enzyme Activity Measurement

    Life Sciences New York (New York) October 19, 2020 Check with publisher

    Creative Enzymes performs the most reliable measurement of enzyme activities for a variety of application purposes. The unique technology platform provides accurate and reproducible results on the activity levels. In addition, our vast library of enz...

  • The Use of Drug Master Files & Quality Agreements

    The Use of Drug Master Files & Quality Agreements

    Medical Sciences Fremont (California) October 14, 2020 Check with publisher

    This combined DMF (Drug Master Files) and Quality Agreement training will discuss the advantages for suppliers and drug product manufacturers in developing these arrangements together. Over time, there have been several misunderstandings between supp...

  • eCTD Submissions of IND/NDA to the US FDA, EU and Canada

    eCTD Submissions of IND/NDA to the US FDA, EU and Canada

    Medical Sciences Fremont (California) October 14, 2020 Check with publisher

    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 globa...

  • 6-Hour Virtual Seminar on Applying ISO14971 and IEC62304

    6-Hour Virtual Seminar on Applying ISO14971 and IEC62304

    Medical Sciences Fremont (California) October 14, 2020 Check with publisher

    Gaps, incorrect or incomplete implementation of safety functionality can delay or make the certification/approval of medical products impossible. Most activities cannot be retroactively performed since they are closely linked into the development lif...

  • Drafting and Negotiating Physician Employment Contracts

    Drafting and Negotiating Physician Employment Contracts

    Medical Sciences Fremont (California) October 14, 2020 Check with publisher

    Overview: In this session Mr. Wolfe will provide practical guidance regarding physician employment contracts,including key regulatory requirements, key provisions and common compensation and common compensation models. Why you should Attend: Today th...