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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New FDA Draft Guidance Part 11 Compliance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..
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..
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..
Sampling Plans for Verification, Validation and Production
This presentation shall describe how to create Sampling Plans for verification and validation, production process validation and production control. The webinar will include the theoretical background of sampling, several examples and formulas for easy construction of sampling plans.Areas CoveredBasic Statistics The main parameters that should be considered Formulas related to SamplingSampling StandardsCour..
Software development for Medical Devices under IEC 62304
IEC 62304 is both a recognized consensus standard by the FDA and a harmonized standard in the EU; therefore, being compliant with the standard is the most expedient path forward for medical device products that are or contain software. IEC 62304 is also called out as a standard under the IEC 60601-1 umbrella and thus compliance to 62304 is also the best path through product safety testing (if applicable to ..
Stability Studies And Estimating Shelf Life With Regression Models
Participants will be able to plan/conduct a stability study and then analyze the results to predict shelf life. They will also be able to explain the results from a statistical perspective. They will learn different approaches for estimating shelf life and will be in a position to select an appropriate method given the situation and constraints. Participants will learn how to appropriately model the data en..
Stability Testing Of Pharmaceutical Products From Regulatory Perspective
This webinar gives a fundamental knowledge of stability testing requirements for establishing storage conditions and expiration of pharmaceutical products.Stability data form an important element of pharmaceutical regulatory submissions. This webinar will provide participants with the necessary knowledge to design and conduct stability studies that meet regulatory requirements. Also, they will be able to de..
Standards – Fact, Fiction or Fad?
This event will help you to learn what the value of standards are including how and when to engage in the development and use of the standards. You will hear some examples of best practices as well as Faux pas’s. You will learn about the various types of standards and what being involved brings you. You will hear about potential tools and the value of relationships and communications in the standards ..
The FDA Inspection: Best Practices for Preparation, Behavior, and Response
This session will discuss how to prepare for the inspection, what to do during the inspection and the close-out interview, and how to respond to the inspection. Also contained in this session will be the limits of the FDA's scope during an inspection, including what documents you are not required to show them, and the permissibility of photographs and affidavits.Areas CoveredTypes of InspectionsPreparation&..
The Use of Statistical Process Control (SPC) Using Control Charts to Maintain Compliance in the Laboratory
Compliance under GLP can be difficult. The setting up of a system to monitor the performance of methods and instruments can lessen this. Statistical Process Control (SPC) uses control charts and statistical guidelines to monitor a wide variety of things in the compliant laboratory. These generate a proactive system to assess problems early on and quickly to be handled by adjustments rather than ..