Congrès management - Formation management

Civil Monetary Penalties and Exclusion

Réf: 29371 Mardi 21 Mai 2019 - Palo Alto ^US

Editorial This webinar will explain the Civil Monetary Penalties Law (CMP) and its mandatory and permissive exclusions and penalties. It will also cover obligations under EMTALA, violations of the Anti-Kickback Statute and Stark including amendments under the PPACA. Objectives Why Should ...

Ethylene Oxide (EO) Sterilization Basics for R&D Engineers

Réf: 29576 Mardi 21 Mai 2019 - Palo Alto ^US

Editorial This Sterilization training will provide valuable information to companies that design products for terminal sterilization with ethylene oxide. Objectives R&D Engineers have the responsibility of the development of medical devices or healthcare products that will be sterilized ...

Dietary, Food and Nutrition Services; Meeting the CMS Hospital and CAH CoPs, DNV Healthcare and TJC Requirements

Réf: 29577 Mardi 21 Mai 2019 - Palo Alto ^US

Editorial Learn about the latest CMS hospital CoPs on dietary, food, and nutrition services in this webinar. The program will also discuss the common deficiencies received by hospitals from CMS. Supplementary information about the C&P process for dieticians provided by CMS will be discussed ...

Latin America: Understanding Regulatory Compliance Requirements Across the Life Science Industry

Réf: 29578 Mardi 21 Mai 2019 - Palo Alto ^US

Editorial The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America [Brazil, Mexico, Argentina]. Written Regulations vs. Skillful Negotiation will be explained across ...

Supplier Quality Assurance Agreements: Why a General Supply Agreement May Not Be Enough with Some Suppliers

Réf: 29579 Mercredi 22 Mai 2019 - Palo Alto ^US

Editorial This webinar will provide you the information you need to create supplier quality agreements (QA Agreements) with key suppliers and to understand which of your suppliers should have these agreements to meet expectations of the FDA and ISO 13485 Notified Body ...

Medical Devices: EU Directives, Guidance Documents, CE Marking Process and ISO Certification Programs

Réf: 29580 Jeudi 23 Mai 2019 - Palo Alto ^US

Editorial This Medical device training will be discussing the requirements of the Medical Device Directives, their linkage to the EU Clinical Trial Directive and the requirements of CE Marking and ISO Certification on commercializing products. Objectives This Medical Device training will be ...

New Elemental Impurities Tests for Pharmaceutical Products According to the New ICH Q3D and USP 232/233 Guidelines

Réf: 29581 Jeudi 23 Mai 2019 - Palo Alto ^US

Editorial This webinar will discuss the new elemental impurities test requirements as per the new ICH Q3D and USP 232/233 Guidelines, the testing required to comply with it and how to do proper risk assessment and analytical measurements, which drug products are within the scope, the ...

ICH Q7 FDA Guidance – Its Structure, History, Application and Writer's Intent

Réf: 29582 Jeudi 23 Mai 2019 - Palo Alto ^US

Editorial In this webinar attendees will learn the background of all sections of ICH Q7 guidance, key critical section contents, the authors intent when writing critical parts of this guidance and how to apply Q7 in an Active Pharmaceutical Ingredient (API) facility. Objectives This program,...

GxP/GMP Requirements and its Consequences for Documentation and Information Technology Systems

Réf: 29617 Vendredi 24 Mai 2019 - Palo Alto ^US

Editorial Attend this webinar to learn the connection between GxP/GMP with document control and IT systems. Attendees will learn how to manage control documents to pass quality audit and information technology systems in compliance with GxP/GMP requirements. Objectives Documentation is the ...

Health Canada Regulations on NHP's vs. FDA's Dietary Supplement Regulations

Réf: 29534 Mardi 28 Mai 2019 - Palo Alto ^US

Editorial This online training will offer an overview of what Health Canada considers to be a Natural Health product (NHP) and review Canadian regulatory requirements for Natural Health products. It will compare Canadian requirements with U.S. FDA requirements for marketing and labeling dietary ...

Supplier and Service Provider Controls: FDA Expectations

Réf: 29615 Mercredi 29 Mai 2019 - Palo Alto ^US

Editorial This training program will provide regulatory requirements (US) of 21 CFR Section 820.50 (purchasing control) for the medical device industry and illustrate the same with examples. It will furnish details on what purchasing/supplier control management systems should ...

How to Conduct Successful Supplier Audits

Réf: 29614 Jeudi 30 Mai 2019 - Palo Alto ^US

Editorial This training program will provide participants with a working knowledge of supplier audits. The why, when, who, how, and what of conducting a supplier audit will be reviewed to ensure that your supplier can meet all your expectations. Objectives When contemplating the use of a ...

How to Prepare a Standard Operating Procedure (SOP)?

Réf: 29613 Vendredi 31 Mai 2019 - Palo Alto ^US

Editorial This webinar will detail a step-by-step procedure on how to write a practical, effective and compliant Standard Operating Procedures (SOPs), review and revise SOPs and maintain compliance over the course of the SOP life-time. Objectives This webinar will instruct the participants ...

U.S. Adverse Event Reporting Regulations for Drugs, Dietary Supplements and Cosmetics

Réf: 29612 Mardi 04 Juin 2019 - Palo Alto ^US

Editorial In order to market dietary supplements and OTC drugs in the U.S., reporting serious adverse events is required. It’s essential to understand these important FDA requirements to assure regulatory compliance and avoid an FDA warning letter or 483 audit issues. Objectives This ...

Risk-Based Verification and Validation Planning to Meet US FDA and ISO 13485 Requirements

Réf: 29607 Mercredi 05 Juin 2019 - Palo Alto ^US

Editorial Developing a Master Validation Plan, evaluating its elements against ISO 14971 hazard analysis / risk management for development of meaningful product validations. FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major ...

FDA’s Expectations from Supplier Management for GMP: Quality Agreements and More

Réf: 29606 Jeudi 13 Juin 2019 - Palo Alto ^US

Editorial The FDA requires that manufacturers of pharmaceutical products have a documented process to assess its suppliers and contract manufacturers, that they have implemented that process, and that the process is effective. This training program will explore how having an effective supplier ...

A Bulletproof, Cost-Efficient Supplier Management Program

Réf: 29605 Vendredi 14 Juin 2019 - Palo Alto ^US

Editorial Attend this webinar to learn the QSR and ISO requirements for supplier evaluation, including defining the types of suppliers that require evaluation, including “critical” suppliers and outsourced processes. Also attendees will learn QSR and ISO requirements for supplier assessment and ...

CDISC Mapping 4: SDTMs and ADAMs Examples (80%/20% Mapping Rule)

Réf: 29616 Mercredi 19 Juin 2019 - Palo Alto ^US

Editorial This training program is intended for anyone directly or indirectly responsible for the creation, content or validation of CDISC data sets, tables, and data lists used to support research, drug or medical device efficacy and safety in a regulatory submission. Through case study ...

Using Kanban JIT Systems to Run a Startup Plant

Réf: 29620 Jeudi 20 Juin 2019 - Palo Alto ^US

Editorial Attend this webinar to learn how to set up and use kanbans, JIT, pull system, and drum-buffer-rope in medical device and biotechnology manufacturing start-up operations. Also attendees will learn elements of lean documents and lean configuration, sterilization lot size, MRP II kanban ...

Streamlining Your Internal Auditing Process

Réf: 29666 Lundi 24 Juin 2019 - Palo Alto ^US

Editorial This webinar will cover creating of a value-added internal auditing program that is compliant to FDA cGMP/ Quality System Regulation and ISO 13485. It will include how to set up and manage the auditing system as well as how to conduct an internal audit and document the results and any ...

Nursing: CMS CoP Standards for Hospitals and Proposed Changes: 2019 Update

Réf: 29667 Mercredi 26 Juin 2019 - Palo Alto ^US

Editorial This training program will cover requirements in the CMS hospital CoP manual on nursing section. It will discuss proposed changes in the Hospital Improvement Act including plans of care, staffing, policy changes, documentation, supervision, nursing leadership, verbal orders, ...

Implementation and Management of GMP Data Integrity

Réf: 29668 Mercredi 03 Juillet 2019 - Palo Alto ^US

Editorial Attend this webinar to learn the regulatory expectations for data integrity during CGMP inspections. Also attendees will examples of data integrity pitfalls, • part 11 compliance data integrity issues, FDA citations related to data integrity and how to improve data integrity in a ...

Scale-Up, Cycle Transfer, and Maximum Throughput Capability for Lyophilized Products

Réf: 29669 Mardi 09 Juillet 2019 - Palo Alto ^US

Editorial This training on lyophilization cycles will cover the process of transferring and or scaling-up a lyophilization process to a larger or different freeze-dryer. It will discuss a methodical approach to understand the thermal properties of a product and simplify the scale-up or transfer ...

Root Cause Analysis - Starting at the Beginning

Réf: 29673 Mercredi 10 Juillet 2019 - Palo Alto ^US

Editorial This failure investigation and root cause analysis training will present a repeatable methodology / defined systems, and simple tools that you can use to trace problems to their source and root cause. Attendees will get knowledge on Flow charts, Cause and Effect Diagrams, the 5 Whys, ...

Basics of Testing Associated with Sterilization Validation and Routine Processing

Réf: 29671 Mardi 16 Juillet 2019 - Palo Alto ^US

Editorial This sterilization validation process training webinar will review the FDA or ISO requirements for tests following validation and emphasis is placed on the appropriate tests for validation, the appropriate routine tests and the frequency of testing. Objectives All sterilization ...