David Margetts, CEO, Factorytalk.
This webinar demonstrates to how to identify and control common risks to manufacturing DI, by applying the latest risk-based thinking to typical GMP scenarios, and using modern (and considerably cheaper) software tools to control and automate quality work.
This webinar will introduce the revision to the ISPE Baseline Guide Vol 5: Commissioning and Qualification. The guide was first issued in 2001 and reflective of that time.
Jessica Shea & Ramesh Raju
This webinar addresses following with reference polymeric materials used in pharmaceutical manufacturing • Regulatory Requirements including the ICH Q3E • Safety assessment of extractables/leachables • Challenges and pitfalls during E&L studies and how to handle them. • Setting up effective E & L Studies • Extraction and right conditions selection, leachable study monitoring and compounds selection, leachable study design.
New draft Annex 1 provides general guidance that should be used for all sterile medicinal products and sterile actives with respect to using the principles of Quality Risk Management (QRM), to ensure that microbial, particulate and pyrogen contamination associated with microbes is prevented in the final product. This presentation will deal with some of the critical issues of QRM.
Beth Kroeger, Richard Chai and Paul Lopolito
This conference has presentations on "Important Considerations in Cleaning Process Development" and "Biofilm remediation and removal".
Igor Gorsky & Susan B. Cleary
This webinar 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 of health-based Cleaning Validation limits and using them in MAC equations is also included. Additionally recommendations on the compliant and sustainable programs and regulator expectations for these programs is discussed.
This educational Session will address : What is Human error ? How to perform a failure investigation ? What Methodology should be followed to determine a root cause? What documentation is required to support a root cause? What are the risks and their impact on the organization? Can only training be an acceptable CAPA ? What should be the role of Senior management ? Importance of trending Impact of Quality culture Importance of Reward and recognition
Dr Pareshkumar Dave
The webinar will introduce the Indian Patent Act 1970 with brief history of the Indian patent regime.
Pharma companies generate vast amounts of data, but how much of that data is readily available to make decisions when releasing the products to market? This webinar will discuss various aspects of Digitalization of Data.
This webinar will give an introduction to QbD concept and will explain with a case study how this concept could be implemented during freeze-drying cycle development and introduce the latest approach for construction of the process design space. This Educational Session will cover
QTTP , Product Design , Risk Assessment
Overview of QbD Procedures, Heat & Mass Transfer in Freeze drying, Case study with step by step implementation of & online tools for calculation.
This training is intended to provide guidance to the audience on the pharmaceutical use of different grades of water from a European regulation perspective.
Objectives of the Webinar Introduce the participants the data integrity controls based on Recommendation for Key Management, Part 1: General (SP 800-57 Part 1 ). Understand the importance of CSV and data integrity when using a cloud-based infrastructure.
Daniel J. Roberts
This webinar will discuss some best practices in an open forum for responding to Form FDA 483, Inspectional Observations, warning letter responses and other regulatory compliance queries.
Failure mode effect analysis (FMEA) risk priority number (RPN) scores have traditionally been used to quantify risks for users, designs, and processes. An alternative to the RPN is the action priority (AP) table.This webinar will focus on An Alternative to FMEA RPN Scores by introducing the concept and utilization of the action priority (AP) table.
The presentation will work through the critical thinking and understanding of business process, system Lifecycle and data lifecycle needed to successfully validate a system for its intended use.
Dr. Lucia Ceresa
The webinar will cover:
This webinar will set out to investigate the key points for consideration in maintaining a strategic approach to Data Integrity (DI) in the Microbiology Laboratory. With focus on the requirements for compliance, the critical factors that impact DI compliance, electronic data and software compliance, and the impact of the human element on DI compliance.
This webinar will focus on difficulties and hurdles faced during data integrity systems implementation, actions taken and success stories. The focus of the webinar will be Risk management approach to overcome data integrity risks , data governance framework , quality culture of an organisation, regulatory requirements ,citations and how to prevent such observations.
The Webinar will cover the discussion about Barrier Systems like Isolators. Barrier Systems like Isolators are the first choice from the regulatory authorities to prevent the direct access from the operators to the aseptic critical zone. I
This Webinar will provide an overview of microbiology principles in steam sterilization and application, as well as autoclave Performance Qualification, regulatory expectations and cGMPs. The presentation will highlight common questions and hot topics in industry to demonstrate the practical application of understanding steam sterilization.