Quality and Safety Regulatory Compliance Training - Live Webinars, Recordings & CDs

This webinar will help you understand the current quality and regulatory paradigm by comparing and analyzing ICH-Q10 Pharmaceutical Quality System and the FDA’s Quality Systems Approach (FQSA) to Pharmaceutical GMPs.

This webinar will focus on the key attributes of an effective cGMP investigation, the role of management, employing quality control tools, CAPA effectiveness checks and Warning Letters associated with cGMP compliance. Attend this training and learn how you can avoid “Failure to Investigate" Observations by FDA.

This webinar provides details regarding the generation of acceptance sampling plans often used in process validation and production control to ensure quality of final products. By attending this webinar, participants will be able understand the key inputs and issues involved in determining acceptance sampling plans. Sampling plans for attribute data are the primary focus although variable acceptance sampling plans are presented as well.

This Objectionable Microorganism training will explore the most current practices that define an objectionable microorganism and will provide a practical approach to determining just how objectionable it really is.

This JPAL (Japanese Pharmaceutical Affairs Law) training will go into the unique post-market challenge of change management facing the Foreign Manufacturer when dealing with its MAH counterpart in Japan.

This Microbiology training/webinar will provide a new approach in ensuring the Microbiological Integrity of Pharmaceutical and Biopharmaceutical Facilities.

This JPAL training will emphasize on Japanese Pharmaceutical Affairs law with respect to - Classification, device approvals, clinical data, MAH (Marketing Authorization Holder),foreign manufacturer accreditation,QMS,post-market complaints & vigilance

This Pharmaceutical compliance training will provide instruction on how to establish and maintain a Maintenance & Calibration program for pharmaceutical instrumentation & equipment.

This Pharmaceutical compliance training will outline actions to take to ensure the microbiological wellness of your facility and will introduce the concept of "Thinking like a Bug".

This Pharmaceutical training will describe strategies and tactics with concrete examples of how you can set up quality systems that will assure compliance and successful operations and will satisfy the agencies.

This Pharmaceutical compliance training will demonstrate how to implement an effective audit program for both manufacturing and the laboratory and the ability to maintain GMP/GLP/GCP compliance with all suppliers and/or vendors.

In this Cleaning validation training we will discuss preparing the cleaning validation protocol. Important aspects such as how to set acceptance criteria and how to measure cleanliness will then be reviewed.

This CAPA training will focus on defining the specific steps to be taken when implementing a CAPA system and review some of the possible pitfalls one may encounter when implementing a CAPA system. This presentation will begin by defining risk in compliance and the methods, which can be used to mitigate risk. One of the methods defined by the regulators and the industry is “Corrective Action Preventive Action” otherwise referred to CAPA. We will first define what we mean by risk. We will then explore the factors associated with risk in compliance. We will also explore risk causing events and how to address them. A review of risk severity/level will then ensue. Upon completion of risk part of the presentation we will define what a CAPA system would look like.

The presentation will focus on CAPA as it applies to risk mitigation. We will define what we mean by a CAPA system. We will further define the tools CAPA uses during implementation. Finally an overview of a CAPA system will be presented and a CAPA approach will be proposed. The approach will focus on defining the specific steps to be taken when implementing a CAPA system and review some of the possible pitfalls one may encounter when implementing a CAPA system. We will also review some of the benefits which may accrue by having a robust CAPA system in place.

This Pharmaceutical training will utilize the Aseptic Processing Guidance as a centerpiece for conducting MDD investigations and will supplement its proposals with additional industry-standard best practices. The scope of the FDA guidance document on Out-Of-Specification results addresses analytical excursions, not microbiological excursions (Microbiological Data Deviations - MDD), although the approach for correcting them is the same: 1) Determine the root cause 2) Determine a corrective and/or preventative action and 3) Demonstrate that the corrective/preventative action was effective. Recent FDA warning letters cite microbiological excursions and many companies are unsure how to correct them since there are no definitive guidance’s. This webinar will utilize the Aseptic Processing Guidance as a centerpiece for conducting MDD investigations and will supplement its proposals with additional industry-standard best practices.

This ASTM E2500 training will review how these ASTM (American Society for Testing and Materials) and ICH (International Conference on Harmonization) approaches can simplify the qualification process. Regulatory groups have responded by providing guidance documents such as ICH Q9: “Quality Risk Management” which encourages a level of risk appropriate to safety and efficacy and provides a toolbox of risk management methods. ICH Q8: “Pharmaceutical Development” encourages the use of scientific methods to mitigate risk through concepts such as Design Space, Quality by Design (QbD), Process Analytical Technology (PAT) and Continuous Verification.

This pharmaceutical training provides a detail review and evaluation of Regulatory requirements on pharmaceutical packaging materials from US and EU. This pharmaceutical training provides a detail review and evaluation of the regulatory requirements for packaging operations including description, suitability, protection, safety, compatibility, performance, Quality Control, supplier, and stability.

This Contamination-Control training will provide valuable assistance to companies that need to validate their cleaning and disinfection programs.

This CAPA training presentation will review Failure Investigations and CAPAs; it will describe methods for meeting those requirements. Many regulated companies still do not have a robust Failure Investigation and/or CAPA programs. Failure investigations and Corrective and Preventive actions (CAPA) are amongst the most frequently found deviations in FDA warning letters. Companies have procedures but either they are not adequate or are not followed. This CAPA training presentation will review Failure Investigations and CAPAs; it will describe methods for meeting those requirements.

This Biopharmaceutical Compliance training provides guidance on industry trends, regulatory feedback, and designs for an effective validation program. Designing an effective disinfectant validation program to meet FDA and EMEA scrutiny. This webinar provides guidance on industry trends, regulatory feedback, and designs for an effective validation program. Current 483's, Warning Letters, and Field Experiences will be conveyed that allow end users to determine that best methods to validate their products against their isolates.

This webinar in designed to provide the basic knowledge needed to create and operate a sterile manufacturing facility.