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

This training program will discuss designing an effective cleanroom facility validation protocol and report, when and how to transition into the routine environmental monitoring processes, how to maintain a state of control within the cleanroom, and the routine environmental monitoring and excursion investigation processes.

This webinar training will cover various topics on Scale-Up and Post-Approval Changes (SUPAC). Participants will learn how to properly scale-up or scale-down pharmaceutical batch process and learn the standard set of documentation to successfully support post-approval changes.

This webinar will help the attendee gain an understanding of the appropriate way to design the processing of all cGMP Controlled raw materials that are used for the manufacturing of drug product. The scope of this webinar applies to all cGMP controlled raw materials that are received, requiring testing, release and issuance of specifications. It also applies to the processing of changes and retiring of previously issued controlled raw materials specification within the product manufacturing process. cGMP Raw materials that are used for product manufacturing has to be released for use in the production process. Guidance will be given as to the steps that every drug product manufacturer should follow in order to process all incoming cGMP controlled raw materials which includes the release for use in the manufacturing of products.

The FDA requires that manufacturers of pharmaceutical products have a documented process to assess its suppliers and contract manufacturers, that they have implemented that process, and that the process is effective. This training program will explore how having an effective supplier relationship management program will result in streamlining the supply chain, ensuring a more consistent level of quality components, materials and components, and be more cost effective to the manufacturer.

This webinar will discuss federal laws on administering and dispensing veterinary medicine, penalties for non-compliance, DEA required records and effective methods to prevent unauthorized use of controlled substances.

This training program will provide participants with a working knowledge of supplier audits. The why, when, who, how, and what of conducting a supplier audit will be reviewed to ensure that your supplier can meet all your expectations.

This webinar will review the regulatory requirements for investigating an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed. A detailed flow chart will be used to help the attendees clearly understand the steps and the order in which they are to be performed. The structure of an Investigation report which properly documents the investigation will be discussed.

This training will cover several recommendations to improve the hospital’s due diligence when administering and dispensing narcotic drugs in a hospital setting and what steps to take to detect and prevent the illicit use or diversion.

This life science product stability testing webinar will explain, in detail, the requirements of the FDA’s drug stability guidelines that are stipulated for drug products and how to design a product stability testing plan that can be applied to new or modified products in the pharmaceutical, biotechnology and medical device industries.

This webinar will give a brief overview of the general procedure for the preparation and documentation of the Annual Product Quality Review and also focuses on the regulations and the regulatory requirements as per US and Europe.

Attend this webinar to learn the regulatory expectations for data integrity during CGMP inspections. The course will review examples of data integrity pitfalls, part 11 compliance data integrity issues, FDA citations related to data integrity. It will teach you how to improve data integrity in a laboratory environment.

This training program will provide the regulatory requirements (US) for complaint handling in the medical device and pharmaceutical industries. The course will touch on complaint sources, and details will be furnished on the interrelationships regarding complaint handling/change control/adverse event reporting/and recalls. The course will also include timeline requirements associated to adverse event reporting, which reporting formats to use, when to recall and types of recalls.

This training program will cover in detail the key elements of HPLC and UPLC method validation to ensure compliance with FDA GLP and ISO 17025 requirements.

This webinar will discuss in detail the methods of sterilization to be used on medical devices and pharmaceutical products including advantages and disadvantages of each method. Also attendees will understand the regulations pertaining to sterilization of products that will help to decide with method to use for their product. Validation of each sterilization method will be discussed and how best to prove to a regulatory body the products being treated are considered sterile.

This webinar will discuss the steps to guide the technology transfer for the successful implementation, ensures that products of the highest quality are delivered to the patients along with meeting the business demands of the company.

This webinar will discuss the regulations pertaining to objectionable microorganisms, agency expectations, methods to identify objectionable microorganisms, interpreting results, and controls to put into place.

This training program will highlight mistakes often made when corrective and preventative actions are not clearly identified and applied during a manufactured product sterility test failure investigation because an ineffective investigational procedure and tool was used to conduct a sterility test failure investigation. The webinar will also illustrate how avoiding such common mistakes will ensure that these types of products meet the sterility requirements USP <71> and other regulatory guidelines applicable to finished products, bulk drug substance, raw materials or excipients.

This laboratory compliance training will teach you how to validate an analytical method under the GLP requirements. It will cover in detail the criteria for the validation of an analytical method including statistical and documentation requirements.

This webinar will help you understand Quality by Design (QbD) principles used in pharmaceutical product manufacturing, outline the key steps to implement a QbD program and discuss the tools used to implement a QbD approach.

This webinar on automating laboratory assays will teach you how to translate an assay that is performed manually to one that is fully automated, with high quality and with proper validation and quality assurance for regulatory purposes.