Food and Dietary Supplements
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..
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..
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..
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..
Best Practices for Managing an FDA Inspection
Although an effective Quality System should always be inspection-ready, many medical device companies make basic mistakes during inspections leading to 483s and even warning letters. This webinar can help you prepare for and manage inspections efficiently and effectively. A professional, polished, responsive approach sets a good tone for an inspection. You will learn how to present information about your qu..
Building a Compliant Laboratory – From Foundation to Business Excellence
Compliance in laboratory settings has been a topic for the FDA and other regulators for decades. With the increased focus on data integrity and continued focus on laboratory investigations, it is critical more than ever to ensure you have designed your laboratory operations system to meet the compliance needs of your business. In this presentation, I will define compliance, provide a translation of regulati..
CAPA, Failure Investigation and Root Cause Analysis to Meet FDA Expectations
Analysis of investigation reports reveals that human error is one of the top root causes for deviations, discrepancies and quality incidents in pharmaceutical manufacturing. And when you examine the CAPA's that are developed from these, retraining and rewrite of SOP is top the list. Yet on further re-examination, you find that these problems keep resurfacing again and again. Put in another way, the CAPA's a..
Cleaning Validation
This webinar discusses global Cleaning Validation as it is implemented in the pharmaceutical and biopharmaceutical industries. In addition, it describes the use of QRM (quality risk management) in Cleaning Validation and the growing trend of applying this approach to the lifecycle of the product manufacturing process. Establishing health-based Cleaning Validation limits also discussed in this session. Addit..
Comparability Protocols for approved drugs
This webinar will address approaches to developing comparability protocols, including primary content considerations and timing of submission. The information obtained will enable the completion of appropriate testing to make changes to the drug substance or drug product formulation, manufacturing facility, and container closure which can be designed to save time and money in the future.Learning ObjectivesA..
Complaint Handling and Adverse Event Reporting, CAPA, Recalls, and Product Life Cycle Management
Complaint handling is essentially the beginning of the process if not one crucial aspect of the process of collecting data concerning the product that is in the marketplace. It is your first “tip-off” that something might not be going as intended. Complaints are ignored at your peril and ignoring them results in a significant risk to the organization and to the patients that use your products.Complaint hand..
Complaint Management: Best Practices to Assure Compliance and 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..
Cosmetic Micro Standards, How to Stay in Compliance
What are cosmetics? Paraphrasing the FD&C Act (The Act), Cosmetics are personal care products applied to the human body for the intention of cleansing, beautifying, promoting attractiveness, or altering the appearance. The operative word here is “intent”. If your products go beyond cosmetic intentions they may also be drugs as defined under the Act: "articles intended for use in the diagnosis, cure, mit..
Critical Planning for Exporting Devices to the EU
Exporting devices to the EU has new EU legal requirements. A device must have a valid CE mark. You must renew your CE mark certification every three years. If you do not, your products cannot be marketed legally in the EU. If your product is not marketed in the U.S. Many U.S. devices are legally marketed in the EU, not the U.S., renewing your CE certification takes planning, a lot of planning. It is n..
Data Governance for Computer Systems Regulated by FDA
Effective and compliant computer system data management is critical to organizations in the pharmaceutical, biologics, vaccines, tobacco, animal health, medical device or other FDA-regulated industry. During the past 30 years, best practices have been developed to ensure computer systems used in these environments can be cost-effectively managed while meeting all aspects of FDA compliance. To take this a st..
De Novo Classification Process
Unlike other countries in the world, the US uses a predicate-based system to classify its medical devices. For devices that have a predicate device in the marketplace, the classification process is quite straightforward. A predicate device is a legally marketed device, called a preamendments device, that was legally marketed prior to May 28, 1976, a device that has been reclassified from Class III to Class ..