Audits & Inspections Training - Live Webinars, Recordings & CDs

This training covers DEA record-keeping and security topics that a DEA registrant must comply with when handling controlled substances. The focus is elements of what occurs during that unannounced inspection and the auditing methods.

The training program will cover DEA record-keeping requirements and effective security that a DEA registrant must comply with when handling controlled substances. It covers elements of what occurs during an unannounced inspection and the auditing methods.

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.

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 2-hr webinar on DEA Due Diligence will cover several recommendations to improve the Corporate Due Diligence when controlled substances and regulated chemicals are purchased by their customers and the steps that can be taken to detect and prevent the illicit use or diversion of any narcotic drug sold to customers.

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 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 training program will examine the approval process for drugs, biologics and devices and elaborate FDA submission requirements and guidances. It will also discuss electronic regulatory submission and gateway for FDA and FDA eCTD guidance and specifications.

This 2-hr laboratory inspection webinar will discuss strategies to implement before your laboratory is about to undergo a pre-approval inspection or a general GMP inspection. It will help you gain an understanding of the key areas that are likely to be the subject of a laboratory inspection.

This webinar will discuss best practices for preparing for an international announced inspection as well as how to be always prepared for those in the US who may be inspected at any time. It also discusses the various roles of the persons who will be assisting during the inspection and suggests how to organize support personnel to aid in keeping the inspection going smoothly and identify and address issues before FDA sees them.

This webinar on selection and auditing of analytical contract laboratories will guide the participants to understand the process of CRO selection for analytical testing. Attendees will gain knowledge on the basic principles of quality auditing of a CRO; including audit planning, scheduling, conducting an audit, and the audit report process.

This webinar will cover FDA’s current thinking on QRM and Guidance for Industry - Q9 Quality Risk Management, provide information to help understanding of QRM concepts, and applications. In addition, brief review of how ICH Q8, Q9, and Q10 work in coherence throughout product lifecycle.

This webinar covers the excipients and APIs regulatory requirements, audit planning and execution, basic to advanced auditing techniques, with emphasis on advancing the auditor’s people-skills, effectiveness and reporting skills.

This webinar provides an overview on the different types of water systems used in the pharmaceutical industry. Attendees will be provided a comprehensive overview of the different types of water systems, their validation, and handling of excursions.

This webinar will provide an understanding of the organizational hierarchy of FDA and Health Canada, your regulatory and quality compliance obligations and the implications of the interactions between these two agencies on your organization.

The presentation is tailored for those corporate leaders and employees of DEA registered manufacturers responsible for handling Schedules I through V controlled substances and List I regulated chemical products. This training will cover several recommendations to improve your methods of record-keeping required of DEA registrants.

This webinar on biopharmaceutical raw material testing will discuss how to implement processes for the control of microbial contamination, establish microbial limits and mitigate the risk of contamination.

This training program will discuss risk management and outline the requirements for applying risk management to the quality system. It will also discuss how to conduct and implement risk management practices at your firm and review communication techniques to highlight the benefits of risk management.

In this webinar, attendees will learn how lyophilization cycles are developed, how lyophilizers work and how they are controlled and what is important to FDA and other regulatory bodies in the inspection of lyophilizers and in the validation process.