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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 and Compliant Technical Writing
This webinar will discuss how to write effective, clear and well-organized technical documents. In this webinar, you will learn how to write in the correct person using the most effective and attention-catching words. The attendees will learn how to write comprehensible clear-to-the-point statements. They will also learn the correct ways to formats to use for each type of Technical document. Areas Covered C..
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..
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..
GMP for QC Laboratory Compliance
In the manufacture and quality control of medicinal products, compliance with the GMP rules is the decisive aspect of manufacturing high-quality products. For this reason, every staff member in the pharmaceutical industry has to be familiar with the basic GMP requirements.Learning ObjectivesThe Good Manufacturing Practice Program provides a comprehensive overview of the best practices regarding the manageme..
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..
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..
Monitoring a Quality Laboratory to Prevent Non-Compliance
Everyone in a laboratory under compliance knows about 3-sigma out-of-control issues. Can the operation be monitored to avoid these? How? This webinar will cover the basic statistics of compliance and non-compliance and how to use a statistical approach to monitor the operation to ensure that it is under control and to see when a problem is arising, but before it is outside of 3-sigma.Learning ObjectivesMany..
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..
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..
Preparing for Successful Pre-IND FDA Meeting
FDA and regulatory guidelines allow for formal meetings between the FDA and sponsors or applicants to discuss the development and review of an investigational new drug (IND) application for drugs or biologic products. This meeting, known as a pre-IND meeting, is intended to address specific questions related to the initial US clinical study (also known as a first-in-human [FIH] study for new drugs and biolo..