All FDA Regulated Industry
COTS, Cloud, and SaaS Systems and FDA Validation Compliance
“How can we perform an Installation Qualification (IQ) when the server is completely under the control of a vendor?”“How do we know the vendor will be able to manage security, backups, disaster recovery, and other aspects required to ensure data is collected and maintained with integrity?”“What about change control?”“How will we handle compliance with 21 CFR Part 11, FDA’s guidance for electronic records an..
Data Integrity 21 CFR Part 11 Compliance
The importance and amount of data being generated to ensure product quality and patient safety continues to grow, and proper controls around that data continue to be a subject of regulatory scrutiny. Regulatory agencies across the world are repeatedly citing data integrity issues. As a result, industry guidance and enforcement strategies are evolving. Regulatory concerns and warning letters have extended to..
Effective Batch Record Review
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 order to properly document all critical processing parameters that go along with the production an..
Equipment Qualification and Validation of Processes
The course will examine best practices to provide thoughts and ideas to develop or improve the performance of your current system. This course will provide discussion on European and FDA regulations as well as global harmonization and expectations. The course will also cover specific aspects of equipment qualification and process validation, such as protocol writing, methodology and performance, report writ..
Establishing a Robust Supplier Management Program
Regulatory expectations are clear about manufactures responsibility regarding supplier quality oversight. All regulatory agencies agree that pharmaceutical and medical device manufactures are responsible for ensuring their suppliers adhere to quality standards, maintain compliance to regulatory requirements and consistently meet established expectations. Therefore, it is essential pharmaceutical and medical..
Establishing Appropriate Quality Metrics and Key Performance Indicators (KPIs)
Establishing appropriate Quality Assurance metrics is important for several reasons. Metrics not only measure the health of your quality system, they have the ability to change behavior, drive quality culture, and improve both individual and company performance. This course will discuss the importance of establishing metrics, how to distinguish Key Performance Indicators (KPIs), as well as, how to utilize t..
FDA Guidance on the Use of Social Media: Know Your Responsibilities and Potential Liabilities
This webinar will help you understand in detail the application of FDA’s guidance on the use of social media in presenting and promoting information about drug products and medical devices subject to FDA regulation. This is critical in order to develop the appropriate strategy, policies and procedures to ensure compliance.Areas CoveredPros and cons of using social media venuesCompliant use of Social Media i..
FDA/ ICH Guideline Q9 (R1) on Quality Risk Management
The training session aims to provide participants with an understanding of the International Council for Harmonization (ICH) Q9 guideline, with a focus on the revised version, ICH Q9(R1). Participants will learn about the principles, concepts, and application of the risk management approach outlined in the guideline, and how it relates to the pharmaceutical industry. This session will discuss some potential..
Good Documentation Guideline(Chapter <1029> USP)
Good Documentation Practices (GDP) are a critical and essential part of a regulated environment (pharmaceutical and medical device manufacturing, R&D, laboratories, and clinical trials). Compliance with GDP ensures an auditable account of work. It ensures integrity and control of documents and is a key requirement for a developed quality system.This training session will cover the US Pharmacopeia Genera..
Good Documentation Practice and Record Keeping Regulations (FDA and EMA)
Good documentation Practices (GDP) are an essential factor that needs to be closely followed by the personnel in any regulated environment as a process for successful project completion including observations of unanticipated responses that are required to be accurately recorded and verified. This Webinar covers the essentials of GDP, its definition, purpose, and importance. Then expands on general rules an..
How to Write and Manage a Change Control System
This webinar will help attendees understand the fundamental change control steps and processes. It will focus on change proposals, assessments, execution and final implementation. The importance of proper planning, critical thinking skills, and co-ordination of all change activities will also be discussed.Areas CoveredIdentify what constitutes a changeLearn how to properly categorize a changeDemonstrate how..
Implementing a Change Control Quality System Successfully
This course will help attendees understand the fundamental change control steps and processes. It will focus on change proposals, assessments, execution, and final implementation. The importance of proper planning, critical thinking skills, and coordination of all change activities will also be discussed.Learning ObjectiveIdentify what constitutes a changeLearn how to properly categorize a changeDemonstrate..
New FDA Draft Guidance Part 11 Compliance
This webinar describesAs part of the Case for Quality program US FDA noted how an excessive focus by the industry on compliance rather than quality may be diverting resources and management attention toward meeting regulatory compliance requirements vs. adopting best quality practices. There has also been a lower-than-anticipated investment in automation and digital technologies, which could greatly improve..
Pharma 4.0: Next Generation Technology Approach to GxP Products, Systems, Data and FDA Compliance
Computer system validation has been regulated by FDA for more than 40 years, as it relates to systems used in the manufacturing, testing, and distribution of a product in the pharmaceutical, biotechnology, medical device or other FDA-regulated industries. The FDA requirements ensure thorough planning, implementation, integration, testing and management of computer systems used to collect, analyze and/or rep..
Preparing for a FDA Inspection
This webinar will discuss the types of FDA audits and why they occur, the Do's and Don'ts during an FDA inspection, how to properly answer questions from an inspector, the significance of 483s and warning letters, as well as lessons learned from previous FDA inspections. Areas Covered Facilities under the watchful eye of the FDAThe 4 types of FDA inspections and why they occurFDA ExpectationsWhat to do befo..