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

Ref: 29580 Thursday May 23rd, 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 ...

Conference & Seminar: Hospital, Management, Research

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

Ref: 29581 Thursday May 23rd, 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 ...

Conference & Seminar: Management, Research

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

Ref: 29582 Thursday May 23rd, 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,...

Conference & Seminar: Management

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

Ref: 29617 Friday May 24th, 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 ...

Conference & Seminar: Management

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

Ref: 29534 Tuesday May 28th, 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 ...

Conference & Seminar: Management

Supplier and Service Provider Controls: FDA Expectations

Ref: 29615 Wednesday May 29th, 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 ...

Conference & Seminar: Management, Research

How to Conduct Successful Supplier Audits

Ref: 29614 Thursday May 30th, 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 ...

Conference & Seminar: Management

How to Prepare a Standard Operating Procedure (SOP)?

Ref: 29613 Friday May 31st, 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 ...

Conference & Seminar: Management, Research

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

Ref: 29612 Tuesday June 04th, 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 ...

Conference & Seminar: Management

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

Ref: 29607 Wednesday June 05th, 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 ...

Conference & Seminar: Management

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

Ref: 29606 Thursday June 13th, 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 ...

Conference & Seminar: Management

A Bulletproof, Cost-Efficient Supplier Management Program

Ref: 29605 Friday June 14th, 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 ...

Conference & Seminar: Management, Internal medicine

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

Ref: 29616 Wednesday June 19th, 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 ...

Conference & Seminar: Hospital, Management

Pharmaceutical Compressed Air - Quality GMP Standards and Requirements

Ref: 29370 Thursday June 20th, 2019 - Palo Alto US

Editorial This webinar will take you through the primary sources of compressed air contamination. It will also detail GMP standards and requirements pertaining to compressed air quality. Objectives Compressed air is often overlooked as a potential source of clean room and product ...

Conference & Seminar: Hospital

Using Kanban JIT Systems to Run a Startup Plant

Ref: 29620 Thursday June 20th, 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 ...

Conference & Seminar: Management

Streamlining Your Internal Auditing Process

Ref: 29666 Monday June 24th, 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 ...

Conference & Seminar: Management

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

Ref: 29667 Wednesday June 26th, 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, ...

Conference & Seminar: Management

Implementation and Management of GMP Data Integrity

Ref: 29668 Wednesday July 03rd, 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 ...

Conference & Seminar: Management

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

Ref: 29669 Tuesday July 09th, 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 ...

Conference & Seminar: Management

Root Cause Analysis - Starting at the Beginning

Ref: 29673 Wednesday July 10th, 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, ...

Conference & Seminar: Management

Basics of Testing Associated with Sterilization Validation and Routine Processing

Ref: 29671 Tuesday July 16th, 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 ...

Conference & Seminar: Management

Process Validation - Overview of Why and How

Ref: 29672 Wednesday July 24th, 2019 - Palo Alto US

Editorial This webinar will provide understanding of FDA and ISO 13485 requirements for process validation and how to implement them. Objectives Learn why process validation is necessary Understand what process validation is Learn about process validation ...

Conference & Seminar: Management

Good Documentation Practice (GDocP) for FDA Regulated Industry

Ref: 29670 Friday August 09th, 2019 - Palo Alto US

Editorial This good documentation practice webinar will discuss how to secure, manage and govern your documentation in compliance with GxP/GMP requirements and be able to pass quality audit. Also attendees will learn the connection between CxP/GMP and document control, which documents need to ...

Conference & Seminar: Management

Cdisc Mapping 5: Adam Models - Adsl, Bds and Adae

Ref: 29604 Wednesday August 21st, 2019 - Palo Alto US

Editorial This training session 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. The program will provide ...

Conference & Seminar: Hospital, Research