Compliance Training Webinars for Regulated Industries

This 60-minute session on master verification and validation planning will discuss the major cGMP deficiencies and "must have" elements from the U.S. FDA cGMP, ICH Q9 and ISO 14971 for hazard analysis and product risk management, and show how you can integrate these into a company's quality management system.

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.

We all want to have a great generic portfolio, but all our competitors also want the same thing - so how do you make sure that you get the winners to market before they do? Do you go for supergenerics, OTCs, smaller volume niches that you can exploit at higher prices - or should you stick to higher volume staples even though margins might be tight? The webinar looks at product selection and who else in the organisation you need to involve to ensure that you get there on time – is it regulatory? production planning? purchasing? strategic planners? The answer is – all of them!

Non-conforming material happens. And medical device companies must deal it. This 90-minute webinar will help you to make sense of confusing regulations and effectively deal with non-conforming material. You will learn where non-conforming material can occur and how to identify, segregate, control, and disposition non-conforming material. You will learn about when and how to conduct failure investigations and requirements for correction and corrective action. Join industry expert, Susanne Manz from Manz Consulting to learn the essentials of dealing with non-conforming material and performing effective failure investigations.

Substandard medications, like counterfeit drugs, present a real and increasing danger both to patients and companies. In this webinar, learn how to take a proactive approach to stay ahead of these problems.

In this program we will start by reviewing the current rules for discharge planning. Are you compliant with these rules? The newly enacted rules that are now required under the Medicare program’s conditions of participation will be reviewed as they may have a profound effect on how case management departments organize their work. Family caregivers and physicians are expected to be much more involved than they have in the past. This program will review the current rules and regulations from the Conditions of Participation (CoP) for Discharge Planning.

Be sure you know the old rules and the new rules so that your practice will be current and legal! We will review strategies for integrating these requirements into your daily practice.

This Change Control training program will discuss regulatory expectations from the FDA, EU and ICH perspective, review all the required components of a thorough change control program; as well as, discuss the elements regarding successful management an effective Change Control system.

There are several steps that must be taken to determine if an incident is a breach, and whether or not that breach is reportable. Determining whether to report or not is not necessarily straightforward, but there are guidelines to follow to help at every step of the way. If the evaluation of necessity to report is not done correctly, you may not make the right decisions about reporting and be subject to penalties for non-compliance upon an investigation of a breach by HHS. Penalties for non-compliance can up to millions of dollars in cases of willful negligence, so it is essential to evaluate incidents to see if they are reportable breaches, and act properly on the evaluation.

It is important that the sterile filtration process is fully understood and properly validated for your particular application. The process requirements and validation needs differ based on the filtration requirement. This webinar will offer attendees a comprehensive understanding of the same while emphasizing the different types of sterilizing filtration available and their application to your particular system. For instance, the application of sterile filtration to use-point compressed air will be discussed in detail.

Pivot Tables are one of the most powerful tools in Excel’s arsenal of data analytics. With just a few clicks, and no complicated formulas or macros, you can quickly and easily build incredibly informative reports, charts and dashboards. In this webinar, you’ll learn Pivot Table techniques that will instantly filter, summarize and analyze huge amounts of raw data. You will learn to use advanced Pivot Table techniques to rapidly produce critical information that will highlight the algorithms and trends buried in reams of data.

In this webinar, you will learn why the FDA requires several validation participants from each “distinct user population”. Learn why the FDA requires many validation participants from each "different user demographic" in this webinar. We'll go over how to determine which tests to run and which studies to finish before the actual validation test.

Environmental, Social, and Governance (ESG) has gained increasing attention over the past few years. Today many institutional investors will only invest in those companies that provide ESG performance reporting. ESG provides a set of standards for a company’s operations that today’s socially conscious investors use to screen potential investments in terms of how a company treats the environment, manages social issues (relationships with employees, suppliers, customers, and the communities where it operates), and deals with governance issues.

In this training program, attendees will discover how to create a record of disruptive behavior and the efforts taken by the organization to combat the problem. The webinar will also illustrate why such disruptive behavior can be a continuing problem; and therefore, why appropriate documentation is imperative.

This webinar will provide an insight into the practical aspects of the Process Analytical Technology (PAT) and will be an invaluable source of information on various technologies and approaches that fit the PAT definitions. You will learn about regulatory initiatives to improve the quality of pharmaceutical manufacturing using PAT and validation thereof. No special technical background is required.

This webinar will outline the aspects and uses of "Time," "Information," and "Power" in negotiation, as well as the elements and uses of the different sorts of "Power."

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.

Responding to the public’s ongoing concern about high and rising drug prices, the Biden Administration and 117th Congress with a fragile Democratic majority have unveiled key proposals to lower prescription drug costs.

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.

In this training program attendees will learn how to manage nonresident alien payee' tax issues in compliance with IRS information reporting and backup withholding requirements for NRAs. Also attendees will learn the five variations of forms W-8 including the new W-8BEN-E just released in Q1-2014. It will help attendees establish which W-8 to provide NRAs working for them.

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.