All FDA Regulated Industry

$200.00
Allergen Cleaning, Validation & Preventative Risk Management

 Recorded Webinar
 60 Minutes
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Allergen Cleaning, Validation & Preventative Risk Management

Allergens are now a Class I Recall by the FDA (Food & Drug Administration), considered an adulterant in foods. It is the largest area for recalls in the US and growing at a staggering rate. Anyone wanting to know how to approach, improve or review their Allergen Management Program should participant to understand the latest information for Best Practice preventative controls. Important elements will inc..

$200.00
An OSHA Inspection in the Laboratory

 Recorded Webinar
 60 Minutes
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An OSHA Inspection in the Laboratory

Do you know why OSHA would come to your lab? Do you know how to respond to an OSHA complaint or allegation? Join Dan the Lab safety Man as he discusses the steps to prepare your lab for an OSHA visit and how to properly respond when it actually happens.Areas CoveredReview the steps in OSHA’s inspection processDiscuss areas in the laboratory where potential OSHA violations are likelyCalculate possible fines ..

$200.00
Answering and Replying to an FDA 483

 Recorded Webinar
 60 Minutes
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Answering and Replying to an FDA 483

A brief introduction into the FDA 483 and its use. Responding and responding appropriately is extremely important. This is not an advanced course on 483 response but a recommended approach to best position your company to prevent even worse FDA regulatory measures. All pharmaceutical and medical device facilities who need to know how to react to FDA 483s. Properly responding to FDA observations will make or..

$200.00
Are You Ready for FDA FSMA Preventive Controls Audit?

 Recorded Webinar
 60 Minutes
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Are You Ready for FDA FSMA Preventive Controls Audit?

Highlights will include an intro to what to do on an audit, how to be ready, what is fair game for review, critical documents required, vital Food Safety Plan, focus on hazards or Hazard Analysis Risk Preventative Controls (HARPC), Supply chain Preventative Controls and importance of managing the audit, sampling, swabbing, warnings and wrap up meeting.Key FSMA Audit takeaway points would include: New FSMA r..

$200.00
Are You Ready for New FDA FSMA (Food Safety Modernization Act) Audit?

 Recorded Webinar
 60 Minutes
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Are You Ready for New FDA FSMA (Food Safety Modernization Act) Audit?

FDA implemented the new Food Safety Modernization Act (FSMA), including the hazard analysis and risk-based preventive in 2016 to help industry manage potential hazards in producing safe food products. FSMA places primary responsibility on the owners and operators of food facilities to identify and control hazard risks, and intentionally grants facilities considerable flexibility in desig..

$200.00
Aseptic Processing Overview and Validation

 Recorded Webinar
 90 Minutes
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Aseptic Processing Overview and Validation

This course will provide an overview of the requirements for aseptic and bulk manufacturing operations, including facility design, contamination controls, and acceptable personnel behaviors.Cleanroom classifications and the techniques for proper cleaning and disinfection are presented; along with a high-level overview of microbiology in regards to cleanroom environmental monitoring and the associated impact..

$200.00
Audit Trail Generation and Review

 Recorded Webinar
 90 Minutes
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Audit Trail Generation and Review

Computerized systems are used throughout the life sciences industry to support various regulated activities, which in turn generate many types of electronic records. These electronic records must be maintained according to regulatory requirements contained within FDA’s 21 CFR Part 11 for US jurisdictions and Eudralex Volume 4 Annex 11 for EU jurisdictions.One of the requirements for such compliance is the g..

$200.00
Auditing Basics and Fundamentals for Medical Devices and Drugs

 Recorded Webinar
 100 Minutes
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Auditing Basics and Fundamentals for Medical Devices and Drugs

Internal audits are not just an important requirement for effective corporate governance – they are intended to show compliance with various domestic and international laws and regulations. Audits are also a fundamental tool of risk management. The auditor assures alignment with prescribed practices and is at the front line in evaluating control systems, testing, measurement and more. Auditors asses the acc..

$200.00
Auditing Quality Suppliers and Vendors

 Recorded Webinar
 90 Minutes
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Auditing Quality Suppliers and Vendors

The various regulatory agencies have expectations that pharmaceutical manufacturers will demonstrate control over their manufacturing processes, validations, and documentation. Quality auditing is the process of checking whether these organizations have implemented what they have stated in written procedures and whether their people are doing what the organizations procedures state they will do.Learning Obj..

$200.00
Automating Assays for Clinical Diagnostics

 Recorded Webinar
 60 Minutes
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Automating Assays for Clinical Diagnostics

Laboratories need to transition technologies all of the time. From new ways to perform assays to outdated technology, to new equipment pushes to the various needs of end-users, assays need to switch between technologies on a regular basis. One needs to be able to easily and robustly transition assays from one technology to another. With this seminar, you will be able to fully understand how your essay is cu..

$200.00
Batch Record Review and Product Release

 Recorded Webinar
 60 Minutes
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Batch Record Review and Product Release

This webinar will analyze each of these necessary elements of the batch record review process.Most Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records. Additionally, there must be written procedures for a batch record review process that demonstrate compliance. A strong batch record review system is essential in ord..

$200.00
Best Practice for Complaint Handling to Assure Customer Retention

 Recorded Webinar
 60 Minutes
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Best Practice for Complaint Handling to Assure Customer Retention

Complaint handling is likely one of the more cross-functional parts of your quality system: Customer Service may receive your customer complaints, Sales and Marketing may need to reach out to the customer for additional information, Regulatory Affairs may determine whether the complaint is reportable, QA may perform the root cause investigation, R&D or Manufacturing Engineering may need to be involved i..

$200.00
Best Practices for a Compliant, Lean Supplier Management Program

 Recorded Webinar
 60 Minutes
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Best Practices for a Compliant, Lean Supplier Management Program

Notified bodies and the FDA cannot require your suppliers to meet the quality system regulations, so they must make sure you are exercising sufficient control over those suppliers. You must make sure your supplier management and system meet all required regulations, especially for critical suppliers. Sure, you depend on your suppliers to provide you with goods and services, but can your system prove that yo..

$200.00
Best Practices for Implementing an Effective Cleaning Validation (using principles of upcoming ASTM E3106)

 Recorded Webinar
 90 Minutes
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Best Practices for Implementing an Effective Cleaning Validation (using principles of upcoming ASTM E3106)

This webinar discusses the implementation of Cleaning Validation programs based on global Cleaning Validation Guidelines as they are currently available for pharmaceutical and biopharmaceutical industries. What makes this webinar special and unique is a very rare glimpse into upcoming ASTM E3106 for Cleaning Validation. This is a Risk-Based Science-Based Lifecycle approach guidance document that was fully v..

$200.00
Best Practices for Investigating Deviations

 Recorded Webinar
 60 Minutes
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Best Practices for Investigating Deviations

One of the most common FDA 483 and Warning Letter citations continues to be inadequate investigations. The FDA uses the investigation reports and investigation trends to identify potential quality problems in all areas of the company. Ultimately, inadequate investigations can lead to 483 citations, Warning Letters, a release of the sub-standard product, or product recall. Furthermore, costly and time-consum..

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