Training Courses, Classes, Seminars and Webinars

FDA and the Customs and Border Patrol Service (CBP) have become increasingly sophisticated and equally demanding in the submission of import information and adherence to government procedures. Firms that fail to understand and properly execute an import and export program find their shipments delayed, detained or refused. As of December 2016, FDA and CBP officially implemented the Automated Commercial Environment (ACE) entry filing system. You either meet ACE requirements or face entry refusals and monetary penalties of up to $10,000 per offense. Other factors can derail the expectation of a seamless import entry process. The course covers detailed information about the roles and responsibilities of the various parties involved with an import operation and how to correct the weakest link(s) in the commercial chain. The course will include tips on how to understand FDA's thinking, negotiate with the FDA and offer anecdotal examples of FDA's import program curiosities.

In Guidance for Industry Process Validation: General Principle and Practices, process validation is defined as, ""...the collection and evaluation of data, from the process design stage through commercial production.." The guidance further delineates the 'process design stage through commercial production' into three distinct stages of the product lifecycle: Stage 1: Process Design: The commercial manufacturing process is defined during this stage based on knowledge gained through development and scale-up activities. Stage 2: Process Qualification: During this stage, the process design is evaluated to determine if the process is capable of reproducible commercial manufacturing. Stage 3: Continued Process Verification: Ongoing assurance is gained during routine production that the process remains in a state of control.

An ALL-NEW Program to Build and Fortify Skills that Transcend Teams
THE FIVE BEHAVIORS PERSONAL DEVELOPMENT PROGRAM is an assessment-based learning experience to help individuals learn what it takes to build truly cohesive and effective teams in the most approachable, competent, and effective way possible. It is grounded in the model described in "The Five Dysfunctions of a Team", the internationally best-selling book by Patrick Lencioni. The goal is to completely redefine teamwork and collaboration.

This workshop includes:

• Continental Breakfast
• Personalized Five Behaviors Personal Development Profile
• 2.5 hours of high-quality classroom time

Schedule:

• 8:30 – 9:00 AM Registration, Networking and Continental Breakfast
• 9:00 – 11:30 AM Program

$149 / person

As a professional, how can you consistently deliver a clear message through compelling visuals– and avoid death by Power Point? Both in delivery and design, your goal is to give the client two ways of understanding your approach: first, through the conversation and, second, through the materials. If either one gets neglected, your impact diminishes. That’s why using proven techniques to visualize and clarify your presentations are essential to convey complex ideas. Exec-Comm’s Crafting High-Impact Presentations program teaches you how to develop your ideas and use design concepts to create compelling decks.

As a professional, you are always looking to improve. Firms are too. Now that you’ve mastered your technical skills, others expect you to lead and innovate. What if you had a set of tools to explore new ways of doing things? Opening yourself and your team to a new approach to solving problems can increase your impact as a manager and a leader. Exec-Comm’s Innovative Thinking program helps you leverage recent research on successful innovators in business.

Whether you love it or avoid it, social media plays a huge role in our business relationships and it shouldn’t be ignored. No matter where you are in your career, most new opportunities arise from your network. So, it’s important to reach your online audience and demonstrate your value upfront. You need to strike a balance between being authentic and personable, while making sure what you share is in line with how you want to be viewed. It can be tough to come across as human and individual through someone else’s computer or mobile device. Exec-Comm’s Social Media Tune Up gives you the tools to build and fine-tune your online brand. Crafting an online brand doesn’t just happen overnight, or by accident. It takes time, effort, analysis, and know-how.

When a business crisis occurs, how do you deal with two simultaneous issues: the crisis itself and the public’s perception of the crisis? Exec-Comm’s Crisis Communication for Senior Executives seminar prepares your executives to control and communicate your corporate message during a crisis to the media and to your key targeted audiences.

How can you successfully communicate with community leaders and government representatives? How do you stay on message and propose viable solutions in these high-pressure situations? Exec-Comm’s Community Dialoging program prepares business professionals to communicate more effectively in large group or one-on-one meetings.

Employees whose professional development stagnates often sap enthusiasm and creativity from their peers. If employees feel their development is ignored, they may leave, creating a brain drain for the company. Both situations often lead to higher expenses and lower productivity. Exec-Comm’s Coaching Toward Excellence program helps you coach and train the people on your team to reach their potential and continue to add value to your organization.

While your new employees may have different expectations of learning, that doesn’t mean they don’t want or need training to become more successful professionals. At Exec-Comm, we have designed a program with these differences in mind. Young professionals often need help putting their best foot forward. Exec-Comm’s From Campus to Corporate workshop will help them be aware of the impressions they make, leverage their personal brand, and receive complex assignments confidently. This workshop will help your young professionals to consider how to best meet the needs of those around them. They will learn to ask better questions in meetings and when executing their assignments, and they will deliver their ideas simply and concisely.

Meeting practices and skills frequently emerge from what feels right and from observed behaviors. Is this the way you want to run your practice or business? Exec-Comm’s Dynamic Meeting Skills teaches business professionals and leaders how to run highly productive meetings that translate into business results. Emphasis will be placed on best practices before, during, and after collaborative meetings.

In today’s demanding marketplace, meetings may be on the phone, by video conference, or online. Successful outcomes will depend on the skills your leaders and attendees bring to virtual, meetings. Exec-Comm’s Connecting in a Wireless World workshop prepares your professionals to communicate with ease in any setting, using technology as an advantage, not a limitation.

Distinguish yourself as a high performer. Launch, expand, or revitalize your career with a strong set of foundation skills - from clear messaging to open body language, from effective emails to embracing feedback.

Rethink how you share information to get what you need from a meeting. Learn to put the needs of your listeners first while refining your delivery skills.

Everything DiSC Certification is for coaches and trainers who want to strengthen how they deliver a DiSC Workshop. This workshop covers DiSC Theory and the history of the assessment. Furthermore, it provides an in-depth look into all of the supporting reports and features of the Everything DiSC Workplace assessment. On the second day of the training, participants will take what they learn and present their 'culminating project' and outline how they can enhance a future DiSC Workshop. Trainers can now receive 15 SHRM PDCs when they successful complete this training.

Learning Objectives: Understanding the different requirements for small versus large molecules Mapping appropriate timelines with decision points Designing, developing, optimizing, and validating key methods Potency methods, other release and stability methods Preclinical and clinical methods Use of DOE and statistical analysis Handling of critical materials Process monitoring concepts Assessment of orthogonal methods Assessing readiness for validation Defining the validation protocol with real-time capture of data analysis Maintaining quality through documentation Who will Benefit: Below titles working in biopharmaceuticals, pharmaceuticals, natural products/botanicals will be benefited by attending this seminar: Validation Scientists QA/QC Regulatory Affairs Laboratory Managers Assay Development Specialists Statistician CMC Titles Bio Assay

Risk management is a mandatory and necessary process during the entire device life. Not only will it help to design and maintain devices efficiently, but it also ensures that the device will be as safe as possible and prevents harms to patients, users, and the environment. Like any process that tries to produce repeatable and consistent results, the risk management process must be clearly understood, including the strengths but also the limitations. By attending this seminar you will learn the main elements of ISO 14971, ISO 13485, IEC62304, IEC62366-1/-2, risk management life cycle steps and benefits, and FDA software reviewers' guidance.

It is no surprise to anyone who reviews regulatory citations to notice the number of deficiencies cited that are associated with quality systems. Today, the basis for all FDA audits both within the US and internationally is based on the quality systems approach and the six systems that comprise it. Whether the audit is a full or partial audit, the quality system within a company will always be inspected and this seminar will help review what are the expectations and the common areas to be familiar with. As a basis for regulatory audits, the quality system, its procedures and their implementation are reviewed to help verify the level of effectiveness in assuring consistent control and quality of materials, components and final product.

The FDA and other Health Authorities worldwide have focused their attention on data integrity, considering data integrity to be a significant risk to public safety. This is evident in the number of Warning Letter observations and related Import Alerts issued in the last 5-7 years. Data integrity is not a new topic, however, but is a part of the GMPs. Often, companies attempt to address data integrity issues procedurally and by conducting numerous training programs. These tend to be ineffective as data integrity issues are often rooted in a company's culture and may be very difficult to address.