Analytical Method Validation, Verification and Transfer

Oct 06-07 In this course, general guideline for the determination of the analytical characteristics for different types of validation procedures

Kelly Thomas

$1,495

Quality and GMP Compliance for Virtual Companies (Pharmaceutical and Biologics Industries)

Sept 28-29 In this two day workshop conference you will learn the requirements and expectations of major health care regulators that are applicable to "virtual" companies

Kelly Thomas

$1,495

Writing and Enforcing SOPs for FDA-Regulated Industry: Best Practices to Withstand FDA Expectations

Oct 26-28 This course will address how to write effective Standard Operating Procedures and Work Instructions in support of company activities

Kelly Thomas

$1,495

Basic GMP Training for the QC Laboratory

Oct 27-28 This course will provide participants with an understanding of how to effectively handle out-of-specification

Kelly Thomas

$4,995

Auditing and Qualifying Suppliers and Vendors - An Effective Risk Based Approach

Nov 02-04 This eight-hour vendor qualification audit training will help you improve quality in your facility.

Kelly Thomas

$1,495

Pharmaceutical Document Management Training Course - A Global Regulatory Approach

Nov 16- 17 This course is designed for individuals responsible for documentation writing and management in the pharmaceutical and related industries

Kelly Thomas

$1,495

CROs (Clinical Research Organizations) - Identification, Selection, and Management for Maximum Results & Value

Dec 01-02 This course will provide the attendees with all the specific methodology and management techniques to successfully outsource pharmaceutical programs

Kelly Thomas

$1,495

FDA Compliant Handling of Out-of-Trend Results in Pharmaceutical Quality Control

MP3 Download This webinar will discuss the FDA requirements and guidelines for investigating Out-of-trend (OOT) results in the pharmaceutical laboratory

Kelly Thomas

$229

GMP Auditing for Quality Assurance Training Course for FDA Regulated Industries

MP3 Download GMP Auditing for the Pharmaceutical Industry

Kelly Thomas

$1,495

Lifecycle Management of Analytical Methods and Procedures - according to new FDA and USP guidelines

MP3 Download This 2-day seminar will explain the new Analytical Procedure Lifecycle guidelines and give attendees the knowledge needed to implement recommend

Kelly Thomas

$1,495

FDA Recalls - Before You Start, and After You Finish

MP3 Download this seminar will help you to Understand FDA's recall authority and policy , Learn how to manage recalls under FDA oversight.

Kelly Thomas

$1,495

Implementing a Robust and Compliant Change Control Program

MP3 Download This Change Control training program will discuss regulatory expectations from the FDA, EU and ICH perspective

Kelly Thomas

$229

FDA Recalls - Before You Start, and After You Finish

MP3 Download this seminar will help you to Understand FDA's recall authority and policy , Learn how to manage recalls under FDA oversight.

Kelly Thomas

€1.595

Navigating the Medical Device Post-Market Maze and Challenges during COVID-19 Pandemic - Learn what FDA is really thinking on regulation and guidance documents

MP3 Download this course will explain how to comply with complicated Complaint Handling, MDR and Recall requirements. Earl Bird. Register.

Kelly Thomas

$1,495

Quality Control Laboratory Compliance - cGMPs and GLPs

MP3 Download This course will examine the fundamental requirements for all QC laboratories subject to FDA inspection, recent trends from FDA inspection reports and enforcement actions

Kelly Thomas

$1,495

EU MDR Implementation and Transitioning to the Deadline: Essential Tasks to Complete

MP3 Download This 2-day virtual seminar will go into the specifics of the European Union Medical Device Regulation (EU MDR), provide case studies and share le

Kelly Thomas

$3,999

Analytical Method Validation and Transfer

MP3 Download This course will provide a thorough review of regulatory guidelines on method validation and transfer

Kelly Thomas

$229

Annual Current Good Manufacturing Practices (cGMP) Training

MP3 Download This webinar provides a basic understanding and fundamental principles of Current Good Manufacturing Practices and will fulfill the requirement

Kelly Thomas

$229

3 Hrs Virtual Webinar on Aseptic Processing and Validation

MP3 Download This course will provide an overview of requirements for aseptic and bulk manufacturing operations, including facility design and contamination

Kelly Thomas

$299

What do the FDA, EMA and PMDA Look for When Conducting cGMP Regulatory Inspections

MP3 Download This webinar will cover the key areas of how ICH Q7 was established, it's goals and objectives, expectations of the healthcare authorities

Kelly Thomas

$499

Lifecycle Management of Analytical Methods and Procedures - according to new FDA and USP guidelines

MP3 Download This 2-day seminar will explain the new Analytical Procedure Lifecycle guidelines and give attendees the knowledge needed to implement recommend

Kelly Thomas

€1.295

Establishing a Robust Data Integrity Program

MP3 Download This webinar will detail a data integrity governance program and principles for defining quality and data integrity into processes and systems.

Kelly Thomas

$199

Establishing Appropriate Quality Metrics and Key Performance Indicators (KPIs)

MP3 Download This course will discuss the importance of establishing metrics, how to distinguish Key Performance Indicators (KPIs)

Kelly Thomas

$199

Webinar Analytical Method Validation and Transfer According to the New FDA Guidance

MP3 Download This course will prepare attendees with the knowledge and tools to plan and execute test method validation packages for the NDA

Kelly Thomas

$499

Post-Market Activities in the EU-MDR — A Detailed Analysis

MP3 Download Medical device training will review the new EU-MDR requirements governing Post Market Activities and discuss quality system approaches

Kelly Thomas

$399

Data Integrity Practices for the Laboratory and Beyond

MP3 Download -Duration 90 Minutes

Kelly Thomas

$199

Upgrade Your Medical Device Recall Strategy

MP3 Download Duration 90 Minutes

Kelly Thomas

$199

Meeting Global Unique Device Identification Requirements

MP3 Download Duration 90 Minutes

Kelly Thomas

$199

Pharmaceutical Quality Risk Management

MP3 Download Duration 90 Minutes

Kelly Thomas

$249

Understanding the Drug Supply Chain Security Act: Latest Regulatory Developments and Best Practices

On Demand Webinar Duration 90 minutes

Kelly Thomas

$289