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Automating Excel - Macros and VBA Fundamentals
Automating Excel - Macros and VBA Fundamentals

$150.00

Overview: VBA is the programming language that is built in to Excel (and the other applications in the MS Office Suite).VBA is used to automate tasks that woul...

The overlap between engineering and psychology
The overlap between engineering and psychology

$150.00

Overview: This course will show how psychological factors enter into the engineering profession. Many aspects of the engineering profession are nontechnical su...

ICH Q11- API Manufacturing
ICH Q11- API Manufacturing

$150.00

Overview: This webinar will address approaches to developing and understanding the manufacturing process for a drug substance. The information obtained will en...

Proper Execution of Annual Product Reviews
Proper Execution of Annual Product Reviews

$150.00

Overview: Annual Product Quality Review (APR) is an evaluation conducted annually to determine if there are any possible changes in the process or manufacturin...

Elements of a CAPA System and Uses of CAPA Data
Elements of a CAPA System and Uses of CAPA Data

$150.00

Overview: FDA offers some relief from the strict requirements if you participate in a voluntary Affirmation of Compliance (AOC). Providing accurate informatio...

Fundamentals of Accounting and Finance for Nonfinancial Professionals
Fundamentals of Accounting and Finance for Nonfinancial Professionals

$150.00

Overview: This program covers a general overview of accounting and financial information and how to interpret reports so that you can make the best decisions i...

Strategies for Billing Medicare For DME-From getting DME PTAN to Full Accreditation
Strategies for Billing Medicare For DME-From getting DME PTAN to Full Accreditation

$150.00

Overview: Learn how to provide your Medicare patients with Durable Medical Equipment to maximize patient clinical outcomes while developing a great revenue str...

Audit - An Essential Tool for Continuous Improvement
Audit - An Essential Tool for Continuous Improvement

$150.00

Overview: This webinar will explore how to improve your internal audit program so it is the efficient and effective tool it is meant to be. Internal Audit is a...

The new EU Clinical Trial regulation
The new EU Clinical Trial regulation

$150.00

Overview: Transition between Directive 2001/20/EC and Regulation EU No 536/2014 Until the Clinical Trials Regulation EU No will become applicable, all clini...

Challenges to relevant Financial Statements and Valuation
Challenges to relevant Financial Statements and Valuation

$150.00

Overview: This course will cover both the telecommunication and technology industries and pinpoint how company operations can be improved. Why should you A...

Software Validation for the New FDA Inspections
Software Validation for the New FDA Inspections

$150.00

Overview: This course will teach how to conduct a software validation program that will satisfy FDA requirements and produce a safe product. Why should you ...

Steam Sterilization Microbiology and Autoclave Performance Qualification
Steam Sterilization Microbiology and Autoclave Performance Qualification

$150.00

Overview: Successful autoclave Performance Qualification starts with a fundamental understanding of steam sterilization microbiology. Why should you Attend:...

SOP Development and Implementation for the Regulated Industry
SOP Development and Implementation for the Regulated Industry

$150.00

Overview: This workshop will explore what SOPs are, what they are used for, when they are required, how to write them effectively for compliance and for implem...

Responding to FDA 483
Responding to FDA 483

$150.00

Overview: FDA policy and goals regarding the 483 response are discussed. Examples of both good and poor responses are given. Warning Letters and responses are...

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...

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