Public Education

Importing FDA regulated products requires careful planning before you even start. Registration, product compliance, record and data submission must be exactly correct or your product will be detained. Likewise, the U.S. Customs and Border Protection (CBP) must be precise or your entry is not going anywhere. Some mistakes are common, others reflect a lack of understanding of how FDA and Customs and Border Protection (CBP) operate a joint program.

Most Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records. Additionally, there must be written procedures for a batch record review process that demonstrate compliance. A strong batch record review system is essential in order to properly document all critical processing parameters that go along with the production and manufacture of pharmaceuticals, biologics, medical devices, etc.

This 6-hour virtual seminar includes a presentation of the steps and techniques used to quantify variability in manufacturing processes, and to assure quality products. The concepts and information presented will be mainly concerned with statistical process control: obtaining monitoring information (data) that is objective, unbiased, and useful for decision making. An emphasis will be placed on the set-up and use of control charts.

Overview: This webinar will help you understand the FDA's requirements for good documentation, including how to handle change control and the importance of audit trails. Why should you Attend: This session will address the specific way of documenting your computer system validation work to ensure it meets FDA requirements and can pass an inspection.

Overview: The webinar highlights steps which employers are required to take to protect employees, including assessing workplace exposures, establishing written exposure control plans and providing worker training. Why should you Attend: If employers follow those specifications, they can be sure that they are providing their workers with the required level of protection. That means that employers will have to implement controls and work practices that reduce workers’ exposure to silica dust.

Overview: Environmental Monitoring is utilized for many reasons in the food industry, but primarily to control pathogens in combination with ones' sanitation program to ensure they are robust. FSMA also requires monitoring or an equivalent program or reasoning if not established for RTE foods. The session will describe how to assess risks, tools needed, recommendations on testing, how to test and best practices, validation of your sanitation program, training requirements, mitigation if positives found, documentation requirements and expectations by the FDA for compliance.

Overview One of the most important qualities of a leader is resilience. Today's leaders are getting barraged with roadblocks, let-downs and failed attempts at success. The true grit of a leader is not how they perform during the good times but rather how they display emotional strength, courage and professionalism during the most trying times. Teams rely on me to be strong, composed and to focus on the intended goals. They needed leaders not to reflect any of the negativity that was surrounding them, but to frame the chaos as an opportunity for everyone to grow. Teams need a leader who will support them and listen to their concerns, but not allow them to stray from what we were trying to accomplish.

Overview For as long as can be remembered, financial markets have thrived under the paradigm that if we do not know future prices, then they must be stochastically determined, therefore Gaussian mathematics is the tool to use. In this webinar, we ask: how sure can we be? Are there no other ways? Why should you Attend For people who use directly financial models, or who build or manage them, or for those for whom ideas of stochastic modeling in financial markets percolate into their own work, they probably are accustomed to the good old paradigm. Some even have forgotten to question if anything unknown anything but stochastic.

Overview Selecting the right Negotiations team, Understand the Union Team. Preparation to Negotiate , Learn How to Listen, Understand the Tactics & Techniques of Negotiation, Learn the Do's & Don'ts of Negotiation. Find out What The Union's Priorities Are? Practice how to Cost Out The Labor Agreement. Negotiations. Utilize Effective Clausing , Obligations of the Offer Counteroffer Process? When to use Employer Pressure Tactics, Learn The Ways To Say No, Create Movement At The Table. Develop The Final Package

Overview In this session, industry veteran James G. Zack, Jr., will discuss impact damages and what they may include. You will gain a better understanding of impact damages and the issues surrounding this form of damages. This session will also explore 10 types of impact damage claims. For each of the 10 types of impact damage claims, Zack, Jr. will identify and discuss one or more potential defenses owners may employ to analyze and resolve impact damage issues.

Overview: Does the FDA call in advance or just show up at my door? Where do I let the inspector go? Do I give them a tour? What should I let them see? Who should I let them talk to? Are they ever going to leave? The FDA inspection is the most nerve-wracking event in the life of a regulatory professional - you're in charge of compliance, usually in the background, and NOW you're in the spotlight, and if your performance isn't good, it's not the show that may close, it's YOUR COMPANY! However, adequate planning, training, composure, and understanding should result in many encore presentations!

Overview: This webinar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject. Why should you Attend: It is not possible to present a complete treatment of project management in the span of 60-90 minutes. It is however possible to focus in on those most critical project management aspects that are critical to the success of any project. Without basic tools, it is not possible to effectively manage a project to the pre-determined end-date without turmoil and chaos.

Overview: Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, supervision, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occurrences. To work with these challenges it is really important to understand human behavior and the psychology of error as well as understand exactly where the systems weaknesses are, so they can be improved and/or fixed.

Overview: The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America. Written Regulations vs. Skillful Negotiation will be explained across every critical topic. The importance of local resources, Agency meetings and knowing how to navigate the regulatory landscape will accelerate country establishment and successful product licensing.

Overview: This webinar describes exactly what is required for compliance with Part 11 and the European equivalent Annex 11 for local, SaaS/Cloud hosted applications. It explains how to write a Data Privacy Statement for compliance with EU General Data Protection Regulation (GDPR). What the regulations mean is described for all four primary compliance areas: SOPs, software features, infrastructure qualification, and validation. It gets you on the right track for using electronic records and signatures to greatly increase productivity and ensure compliance.

Overview: This 3-Hour webinar covers the details of the Regulatory Requirements for a wide-range of Life Science products in Japan: Pharmaceuticals, Biologics, Medical Devices and Combination Products. The syllabus also covers the change in Japan caused by the re-write of the Pharmaceutical Affairs Law [PAL] into the Pharmaceuticals & Medical Device Law [PMDL] and the country's latest update to GMP requirements.

Overview: How CAPA's are executed and managed is crucial to maintaining a compliant organization. Inadequate CAPA processes continue to be a major GMP deficiency and consistently make the FDA's top five list for adverse observations. The primary objective of this webinar is to heighten awareness of the importance of the proper execution of the CAPA process to the organization, to the efficacy of the product and to the safety of patients and customers, and to describe the structure and function of an effective CAPA system.

Overview: You will learn the following in this webinar, The quickest and best ways to create PivotTables and Pivot Charts, including these capabilities: The following subjects will be covered in detail: The following subjects will be covered in detail: How to compare two or more fields in a variety of layout styles How to sort and filter results How to perform ad-hoc grouping of information

Overview: Learn how to quickly spot violations in the workplace and how to correct them to OSHA standards by attending this webinar. The attendee will also be made aware of the most frequent violations, compliance strategies and the defense against citation. OSHA has a playbook that is used by each compliance and safety officer; the attendees will learn how to obtain a copy for free and tips for learning the content. Moreover, this webinar will give practical steps to an effective Injury and Illness Prevention Program (I2P2).

Overview: It has often been stated that "FDA inspects for compliance; European inspectors inspect for adequate science". Yet GMPs have been enshrined into law for many countries and a drug/biologic/medical device manufacturer should have a reasonable expectation of all inspections being the same.