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CAPA, Failure Investigation and Root Cause Analysis to Meet FDA Expectations
CAPA, Failure Investigation and Root Cause Analysis to Meet FDA Expectations

$150.00

Overview: Defined Failure Investigation and Root Cause Analysis is a major tool in product complaint, non-conformance, and OOS failure investigations, and ha...

New FDA or EMA and USP Guidelines for Transfer of Analytical Methods
New FDA or EMA and USP Guidelines for Transfer of Analytical Methods

$150.00

Overview: When validated methods are transferred between laboratories and sites, their validated state should be maintained to ensure the same reliable resul...

Medical Device Employee Training -Requirements and Implementation tips
Medical Device Employee Training -Requirements and Implementation tips

$150.00

Overview: This is especially true for start-up and other small medical device companies, or rapidly growing companies. Specific FDA training requirements wil...

Phase I GMPs
Phase I GMPs

$150.00

Overview: Early clinical trials are conducted to establish initial safety of a drug. The studies are generally in small number of healthy subjects and use lo...

FDA Scrutiny of Promotion and Advertising Practices
FDA Scrutiny of Promotion and Advertising Practices

$150.00

Overview: DTC may be deemed as misbranding your product and, therefore, may not be marketed. Firms must be more sophisticated now in designing their advertis...

How FDA Trains its Investigators to Review CAPA and What You Should Do to Prepare
How FDA Trains its Investigators to Review CAPA and What You Should Do to Prepare

$150.00

Overview: In this session will be a section-by-section summary of the CAPA subsection of the QSIT, the document by which FDA inspectors operate during an ins...

Understanding and Implementing a Technology Transfer Process
Understanding and Implementing a Technology Transfer Process

$150.00

Overview: It will cover the concepts associated with transferring the scientific technology needed to manufacture the product, processes to ensure the receiv...

Excel Spreadsheets - Step-By-Step Instructions for Compliance
Excel Spreadsheets - Step-By-Step Instructions for Compliance

$150.00

Overview: This interactive webinar provides explicit details and live demonstration followed by a collaborative workshop that explains how to configure and val...

Understanding International ACH
Understanding International ACH

$150.00

Overview: Instructor will cover customer benefits and value proposition regarding International ACH and why it may be preferred over wire transfers. Why s...

Tools for Human Error Reduction
Tools for Human Error Reduction

$150.00

Overview: Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever ...

Use of Electronic Health Record Data (EHR) in FDA regulated clinical investigations
Use of Electronic Health Record Data (EHR) in FDA regulated clinical investigations

$150.00

Overview: This webinar will discuss FDA's current recommendations on using electronic health records in prospective clinical investigations of human drugs, bio...

Good Deviation Practice What you need to know
Good Deviation Practice What you need to know

$150.00

Overview: This course explores the deviation and CAPA processes and best practices for both. It shows how to avoid pitfalls and minimize regulatory scrutiny by...

Advertising and Promotional material compliance and review process
Advertising and Promotional material compliance and review process

$150.00

Overview: You will hear about the opportunities for input from regulatory agencies at critical stages and on key promotional materials and you will hear strate...

Supplier Evaluation and Assessment How to Meet FDA QSR and ISO 13485 Requirements in a Cost-Effective Manner
Supplier Evaluation and Assessment How to Meet FDA QSR and ISO 13485 Requirements in a Cost-Effective Manner

$150.00

Overview: A lack of adequate control over purchases has resulted in a significant number of recalls due to component failures. Since FDA does not directly regu...

FDA Regulations for Analytical Instrument Qualification and Validation Processes
FDA Regulations for Analytical Instrument Qualification and Validation Processes

$150.00

Overview: In this webinar you will learn the different global agencies expectations of analytical equipment qualification along with the development of a sou...

Implementing Cost Effective Regulatory Compliance
Implementing Cost Effective Regulatory Compliance

$150.00

Overview: This webinar will introduce and overview the concept of containing compliance costs - working smart. The webinar will provide a comprehensive strat...

Theory of Constraints
Theory of Constraints

$150.00

Overview: This applied to his logistics system, which another reference depicted as a "continent spanning conveyor," but continuous flow in his factories ach...

PMBA - Project Management Business Administration
PMBA - Project Management Business Administration

$150.00

Overview: This course begins with general principles of Project Management Business Administration (PMBA) and continues to elaborate on specific topics relev...

ISO 134852016 Utilizing Lean Documents and Lean Configuration
ISO 134852016 Utilizing Lean Documents and Lean Configuration

$150.00

Overview: The webinar will first present the key differences between ISO 13485 2015 versus ISO 13485 2003.Next, the speaker will provide an overview of the u...

Analytical Method Validation
Analytical Method Validation

$150.00

Overview: An analytical method is a process. The FDA process validation guidance applies to test methods, like all other processes in the pharmaceutical indu...

Understanding and Implementing USP 1058 Analytical Instrument Qualification
Understanding and Implementing USP 1058 Analytical Instrument Qualification

$150.00

Overview: Analytical instruments should be qualified to demonstrate suitability for the intended use. Despite the fact that instrument qualification is nothi...

Metrology Statistical Analysis of Measurement Uncertainty
Metrology Statistical Analysis of Measurement Uncertainty

$150.00

Overview: The webinar begins with an examination of the fundamental vocabulary and concepts related to metrology. Topics include: accuracy, precision, calibr...

Packaging and Labelling for Commercial and Clinical Products
Packaging and Labelling for Commercial and Clinical Products

$150.00

Overview: The program will review how to establish an effective artwork change management and approval system, including real-life examples of system success...

Efficient and Effective FDA and ISO Management Reviews
Efficient and Effective FDA and ISO Management Reviews

$150.00

Overview: In this presentation will cover the requirement for management review from FDA cGMP and ISO 13485 and approaches that can make these effective. Man...

How to Conduct a Human Factors - Usability Validation Test following ISO 62366 and the 2016 FDA Guidance
How to Conduct a Human Factors - Usability Validation Test following ISO 62366 and the 2016 FDA Guidance

$150.00

Overview: This webinar will explain the procedure described in ISO62366 and the 2016 FDA Guidance for a compliant human factors/ usability validation. HF/U v...

Design Inputs Design Outputs Traceability Matrix
Design Inputs Design Outputs Traceability Matrix

$150.00

Overview: If your design and manufacturing resources are spending too much time on documentation and not enough time on actual design and manufacturing you as ...

1099-MISCBlock By Block Discussion
1099-MISCBlock By Block Discussion

$150.00

Overview: This course will cover not only these common mistakes but make suggestions regarding the contents of each Block on the Form 1099-MISC. Why shoul...

Managing Client Expectations Without Losing Your Shirt or the Next Job
Managing Client Expectations Without Losing Your Shirt or the Next Job

$150.00

Overview: By learning to present issues in the right framework we decrease adversarial behaviors on the project and increase the likelihood that our proposals ...

Acceptance Sampling by Variables
Acceptance Sampling by Variables

$150.00

Overview: This presentation covers the methods in Z1.9 and shows how to use most common choice, standard deviation unknown. The presentation explains how a sim...

Preparation for GMP Inspections by Regulatory Agencies
Preparation for GMP Inspections by Regulatory Agencies

$150.00

Overview: This webinar will provide practical tips and advice for ensuring that all inspections are conducted in the most effective and efficient way possibl...

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