Supply Chain and Manufacturing Regulatory Compliance Training - Live Webinars, Recordings & CDs

This training program will discuss MHRA GMP data integrity definitions and guidance. It will also highlight the difference between intentional and unintentional failures of data integrity and examine how regulatory agencies detect data integrity problems.

This training program will provide tools require to understand what a good Request for Proposal (RFP) looks like, how to write one, and how the job of selecting a vendor becomes easy when these tools are employed.

This training program will provide a review of the current testing requirements and discuss what happened to the old 87/91 LAL Guidance for Industry proposed guidance. The program will also discuss how to transition from one bacterial endotoxin test to another—understanding the RPT (Rabbit Pyrogen Test). Participants will also gain a clearer perspective of the Monocyte Activation Test (MAT).

Attendees will come away from the training program with the tools they need to understand the various types of enclosures and how to select the correct type of enclosure for their process in order to meet regulations, protect the product, and ensure worker safety. The course is apt for personnel in FDA regulated industries who want to learn about what enclosure is best suited for their process and why.

This webinar will discuss in detail key auditing elements of an Active Pharmaceutical Ingredient (API) facility/operation. It will cover selection, designation and documentation of starting materials; qualification of analytical methods; control requirements for multi-product/multi-processing API production facility; QA review and release of API and much more.

This webinar will focus on the current trends in FDA inspections and guidelines that can be implemented to ensure compliance with the latest quality and regulatory requirements. Attendees will learn how to prepare for an FDA inspection to avoid Warning Letters.

This training on auditing of software vendors for FDA compliance will explain the types of audit and its use in qualifying and selecting vendors. It will discuss sample forms and checklists which may be used by the participants for observations, recommendations and remediation.

This webinar discusses methods for estimating process capability for both normal and non-normal data. Methods include estimating the proportion of defective products that may be produced as well as the calculation and use of common process capability indices (e.g. Cpk and Ppk). Process Capability assessments are discussed in the overall context of quality improvement/management.

This webinar will focus on the regulatory and design requirements for an effective change control system in the pharmaceutical industry. Attendees will learn the role and importance of change control system in implementing an effective quality system.

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 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.

This Laboratory compliance training will help to understand and implement the new USP chapter.

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 Webinar covers REMS provision and Impact on Pharmaceutical Marketers.

This program will examine the benefits of outsourcing in China along with the risks and review possible solutions needed to enhance supply chain security while consistently delivering safe products to the consumer/patient.

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.