Tri50 – COVID-19 Response Manufacturing Support

The most recent challenges for the economy for the Coronavirus are devastating to the entire US business sector and all private households. Many wonder how this can happen. Markets and supply chains will change. Also, customer behavior and consumption patterns will change for both individuals and businesses. There is risk in following old patterns – there is opportunity in re-thinking plans and updating business models.

This 5-part course covers the following topics:

1. Understanding the new normal and taking advantage of available resources (4 hours)
2. Assessing your current business situation and envisioning the future (4 hours)
3. Analyzing market opportunities for revenue growth (4 hours)
4. Optimizing your business model to improve profitability (4 hours)
5. Developing your strategic plan and coaching for asuccessful implementation (4 hours)

Participants in this training will:

• Understand the resources available for businesses
  impacted by the crisis
• Better understand the current market environment and its
  impact on businesses
• Develop a plan and strategies for coming out of the
  corona virus crisis successfully

Based on this knowledge it will be easier to:

• Identify opportunities and challenges for your business
  going forward
• Grow revenue, increase profit, and obtain financing
• Recover quickly and emerge from the crisis stronger

The new nature of work has impacted employee morale and safety. Learn organizational strategies for maximizing productivity and retention in the COVID-19 work environment, and practical steps to help employees regain focus and connection

Companies can select up to 8 topics of discussion and recommendations from the below options:

• Workplace Safety (ie. employee health screening, PPE, visitor protocols, etc)
• Sustaining a remote work force
• Recall procedures of employees returning to work
• Employee Benefits (revised eligibility requirements, paid leave, etc.)
• Employee retention and engagement
• Soft skills to manage emotional sensitivity and awareness of staff
• Assess current talent needs (review job descriptions, assess internal weakness when it comes to staff/upgrading talent, and succession planning)
• Communication plan to employees and customers
• Hiring process (What this should look like Post COVID-19, including automating the pre-hire and remote onboarding process, as well as I9s – employment eligibility confirmation)
• Automation of business tools for payroll, applicant tracking, performance reviews, etc.

In a post-COVID-19 world, your digital marketing is more important than ever before. In these lessons we’ll educate manufacturers on how to maximize their existing digital marketing efforts and introduce some new, powerful marketing tools.

SESSION ONE: Your Website and Search Engine Optimization, Content Management Systems (4 hour course)

An in-depth look at how to make the most of your website. Your site shouldn’t just sit there. It should be working to bring in leads, educate potential customers and convert visitors. We’ll talk about why it’s critical to have a website that features a Content Management System that allows almost any employee to edit the site quickly and easily to get important information online quickly. You’ll learn how to set your site to funnel visitors to the information they are looking for in as few clicks a possible. You’ll learn what your site needs to convert visitors to customers and the importance of using Google’s best practices when setting up your site’s back-end to make sure you get found.

• BENEFITS: Getting found on the web represents a significant challenge in a highly competitive marketplace. We’ll make sure that your site is set up according to Google’s Best Practices. This gives you an edge over your competition by ranking your page as high as possible in search results. More traffic equals more business. We’ll also teach you how to set your site up in a way that allows you to make changes quickly and easily, without additional cost or delays.

SESSION TWO: Automated Marketing (Hubspot, Salesforce, Act-On) (4 hour course)

Automated marketing helps sales operate more efficiently by monitoring how potential customers are engaging with your marketing efforts (or not) and takes action. From Lead Scoring to Landing Pages, these tools act as force multipliers to give your sales and marketing efforts a vitally guaranteed boost. We’ll look at each platform, discuss strengths and weaknesses and determine which is right for you.

• BENEFITS: Automated Marketing gives your sales a boost by not only monitoring how your existing customers are engaging with your marketing, but it also identifies behaviors and patterns that spotlight potential new clients that might otherwise have been missed. By using Automated Marketing you’ll be able to engage with your audience on a one-to-one basis with minimal effort and be able to see real, actionable results.

SESSION THREE: Brand Strategy (4 hour course)

A consistent, strategic message is the single most important part of any marketing campaign. You’ll learn how to refine and control your brand image and message. We‘ll teach you how to create ads and ad messages that accurately communicate with potential customers and how to tailor that message to different market segments without losing your brand identity. This session will also cover how to A/B test your marketing and how to calculate ROI for all of your marketing efforts. As a bonus, we’ll teach you how to see what your competition is doing, their digital strategy, what they spend on some portions of their marketing and how to gain a strategic advantage. In this lesson we’ll also cover content marketing, Remarketing, Pay Per Click, Display Ads and more.

• BENEFITS: We’ll look at your business from the inside out and work with you to effectively communicate your organization’s value to customers. We’ll build a model of your ideal customers, then use our skills to get your message in front of them. Better exposure of an effective brand message converts potential clients to paying customers.

SESSION FOUR: Social Media (4 hour course)

The single most powerful marketing tool ever created can be a benefit or a burden – it’s up to you. Taking control of your social presence can give you insight into existing and potential clients, help you engage with your audience and improve your brand perception. We’ll look at which platforms you should use and how to use them effectively

• BENEFITS: Social media marketing puts the power of Artificial Intelligence and audience engagement to work for your business. You’ll get to know your audience like never before. You’ll learn to nurture and solidify existing relationships while identifying and reaching out to new business.

SESSION FIVE: Other Media – Podcasts, Blogging, Apps and Video (4 hour course)

Manufacturers tend to stick to more traditional means when it comes to marketing. We’ll take a look at some marketing techniques and platforms that can have a tremendous impact on sales. We’ll teach you how to easily create a podcast, a video channel on YouTube, or a company blog. We’ll also look at developing your own app.

• BENEFITS: Traditional advertising in 2020 is anything but traditional. Utilizing alternate platforms like podcasts, blogs and video will present your business to potential new clients in a way that feels less intrusive and blurs the line between marketing and entertainment. This grows your reach and delivers your brand message in a more personal way.

We all face risks and vulnerabilities. Not every risk can be eliminated. While some risks can be mitigated, disasters and crises will happen. Establishing a clear crisis management plan with identified leadership authority positions an organization to manage a crisis effectively. Identifying what needs to be monitored with predetermined triggers for actions empowers people to act immediately. Having predetermined roles and responsibilities positions leadership to implement actions consistent with strategy and brand. The middle of a crisis is not the time to start trying to figure who the players are and what the game plan is.

Mapping the right route to any destination requires some missioncritical facts: Starting point. Distance. Best and Alternate routes. Without this information, the map is unlikely to guide you or your organization to the right outcome in an efficient manner.

NJMEP’s Emergency Communications & Managing Risk Workshop is designed to identify your preparedness needs, design the plans, policies and procedures that will empower you to make the decisions you need to make before during, and after a crisis.

Topics include:

• PANDEMIC / COMMUNICABLE ILLNESS PLANNING
• EMERGENCY RESPONSE PLAN
• BUSINESS CONTINUITY PLANS
• CRISIS MANAGEMENT AND CRISIS COMMUNICATION PROGRAM
• IT-DISASTER RECOVERY PLAN
• WORKPLACE VIOLENCE PREVENTION PROGRAM

PANDEMIC / COMMUNICABLE ILLNESS PLANNING (4-hours)

As we have learned, unlike other threats and disasters, a pandemic will affect everyone, everywhere. Covid-19 has had a devastating impact on the global business and investment community and has threatened the very survival and recovery of every organization.

Using our methodology, NJMEP will work with the client to deliver the Communicable Illness Planning ToolKit™. The ToolKit is presented in an actionable format, ready for immediate implementation and provides the processes, forms and supporting documents to help a client develop a customized action plan for managing communicable illness outbreaks.

EMERGENCY RESPONSE PLAN (4-hours)

Using the methodology NJMEP will guide the client through the design of an emergency response plan (ERP). The approach will include an ERP digital master that will be created based on the clients’ site-specific physical structure and environment.

Implementing an emergency response plan (ERP) enables a timely response to an emergency event, with the objective of protecting people and property and satisfying stakeholder expectations. NJMEP will prepare a custom emergency response plan (ERP) for the site that will meet and, in most cases, exceed any applicable state laws or licensing regulations.

BUSINESS CONTINUITY PLANS (4-hours)

Business continuity plan development includes not only preparing for, and the mitigation of, major disasters (e.g. total loss of a building), but also routine interruptions to service and daily operations. It puts business disruption planning in perspective and makes it more likely the impacts from such disruptions are lessoned, due to predetermined response and recovery actions.

Whether the term “Business Continuity” or “Continuity of Operations” is used to define the preparedness program, plans must be put in place to mitigate or eliminate as many exposures as possible. Strategies must be developed to take advantage of opportunities. For institutions with a drive to excel, the responsibility to ensure the continuity of operations, security, and safety of the organization, its people, and stakeholders requires regular attention.

CRISIS MANAGEMENT AND CRISIS COMMUNICATION PROGRAM (4-hours)

The fundamental objective of crisis management planning is to establish a process for employees to detect, quickly address, and escalate an incident to the crisis team before it significantly impacts the company. Crisis management planning positions senior leadership to address all types of crises that, if materialize, will require unique response strategies, actions, and supporting communications.

An actionable crisis management plan (CMP) is instrumental to the management of, and response to, any crisis event. The crisis management plan represents the core crisis management doctrine and explains the organizational approach to managing a critical incident. It constitutes the strategic level plan for management of a crisis event and allows for a coordinated response with internal operations and to impacted stakeholders.

IT-DISASTER RECOVERY PLAN (4-hours)

Information Technology-Disaster Recovery (IT-DR) plans are a critical component that intersects with business recovery because there is an inherent relationship between IT systems and the business functions they support. Therefore, when an organization is implementing an IT-DR strategy, that strategy and the people and processes needed for recovery, needs to be well documented in an IT-DR plan.

NJMEP’s process is designed to ensure that an organization’s IT-DR planning capabilities support critical operations in the event of a disruption. NJMEP’s customized IT-DR Plans are written in coordination with an organization’s other existing plans.

WORKPLACE VIOLENCE PREVENTION PROGRAM (4-hours)

A NJMEP, Workplace Violence Program provides clients a framework specific steps for prevention of – and response to threats or incidents of workplace violence. Working with NJMEP, clients will help develop documentation, create the procedures for safeguarding employees and property against workplace violence incidents such as theft, sabotage, vandalism, and acts of terror.

The NJMEP Workplace Violence Program provides a systematic approach to engage senior leadership, conduct analysis of hazards and risks, design policies & procedures, and manage potential and realized threats of violence.

EMPLOYEE HANDBOOK (4 hours)

Did COVID-19 uncover gaps in your employee handbook? Have you now recognized the need to publish an employee handbook for your company? For those with an employee handbook, this session will give you the opportunity to review your handbook against best practice standards and identify areas missing or needing enhancement, including a telecommuting policy. For those considering creating an employee handbook, this course will give you a roadmap on how to get started.

EMPLOYER/EMPLOYEE POLICY (4 hours)

Families First Coronavirus Response Act (FFCRA or Act) was signed into law on March 18, 2020. It requires certain employers to provide their employees with paid sick leave or expanded family and medical leave for specified reasons related to COVID-19. These provisions will apply through December 31, 2020. This session will give you an opportunity to learn answers to some of the most common FFCRA questions related to businesses.

SUPERVISORY SKILLS TRAINING (12 hours)

COVID-19 highlights the need to rapidly adapt to change. This 12-hour program, delivered in 4 hour segments, is designed to provide managers and supervisors with the necessary knowledge to respond to the changing demands and uncertainties presented by COVID-19.

Session One
• The Impact of COVID-19 on Work: Communication Strategies to Stay Connected

Session Two
• Establishing Performance Expectations and Providing Feedback for On-Site and Remote Workers

Session Three
• Building Resilience and Managing Stress for You and Your Team

Safe, Sanitary, Online *LIVE* Food Safety Training!

Keep your food manufacturing team upskilled and business compliant during the COVID-19 pandemic. Critical food safety training and business growth options for food manufacturers are now available online. Maintain social distancing while continuing to offer professional development opportunities.

Virtual training programs for food manufacturers – Keep employees healthy and your business in compliance.

Please select 5 of the 8 offereings to equal 20 hours of total virutal training

Here’s a list of all the food courses being offered virtually:

• FSMA Readiness Review
• COVID-19 Sanitation & Hygiene Review
• GMP Internal Auditing Overview
• Food Safety Overview for Executive Management
• FDA Labeling Overview
• Pivoting Channels during COVID-19
• Fortifying Supply Chain during COVID-19
• Are you ready for GFSI?

FSMA READINESS REVIEW (4-hours)

Overview of Food Safety Modernization Act (FSMA) Regulations. FSMA covers seven regulations that have been waved in for various compliance since 2015. The most recent being IAVA Food Defense. This course covers the seven regulations, the enforcement timelines, and the action steps that are necessary if you aren’t meeting federal regulations.

COVID-19 SANITATION & HYGIENE REVIEW (4-hours)

Times have been uncertain during COVID 19. This course covers how to review your Health & Hygiene Policy and Sanitiation practices during the pandemic and make potenital improvements based on federal and supply chain food safety guidelines.

GMP INTERNAL AUDITING OVERVIEW (4-hours)

How do you prepare for your upcoming GMP audit? What are the differences between cGMP and GMPs? Are they the same for all food, beverages, dietary supplements? This will be covered as well as the basic checklist on how to ensure you have the right internal checks and balances in place based on processes, inspections, and personnel to better prepare for your 3rd party audit.

FOOD SAFETY OVERVIEW FOR EXECUTIVE MANAGEMENT (4-hours)

As a business owner or C suite professional this course covers the following areas that are essential for running a food and/or beverage manufacturing facility: key regulatory and supply chain terminology and phrasing to be aware of, required training, federal ramifications from a regulatory perspective if there are non compliances found from an FDA Inspection, and how to improve your food safety culture at your organization.

FDA LABELING OVERVIEW (4-hours)

The FDA has issued new labeling guidelines to be enforced by Jan 1st, 2021. This course will cover the basics for paneling requirements, nutrition facts, and display ratios for the finished principle display panel(s). The course will also highlight ingredient statements and specific review of allergen declarations..

PIVOTING CHANNELS DURING COVID-19 (4-hours)

Are you looking to be more nimble during COVID 19? Are you looking to diversify your customers, expand your offerings? Maybe you have previously only sold to restuarants or food service establishments and now you are looking to penetrate retailers or ecommerce sectors? This course will cover the different regulatory scope of each of these options so you can compare and contrast and make an informed business decesion.

FORTIFYING SUPPLY CHAIN DURING COVID-19 (4-hours)

During COVID 19 there has been a shift from international to domestic suppliers based on supply and demand. As a food manufacturer how do you make this transition with primary and secondar suppliers? What are the risks, what are the benefits? How does your Food Safety Supply Chain program shift? Details for PCHF and FSVP will be reviewed.

ARE YOU READY FOR GFSI? (4-hours)

What are your next steps for your company? Are you looking to grow the business based on the marketplace depands? Customer requirements? Look no further, this course will cover a comparison of international food safety management systems (FSMS) SQF, BRC, and FSSC 2200 so you can make an informed decesion about what model is best for your company at this time.

The goal of this course is to provide students with an understanding of concepts of processes within an organization and the role of internal auditing in promoting process improvement and risk management. Students will gain an understanding of the use of process metrics as a tool for process improvement.

Students will also gain an understanding of different types of internal auditing and how effective auditing can lead to process improvement. We will cover different types of auditing, including the use of virtual audits during lockdown and organizational recovery. We will cover techniques in auditing and the students will participate in simulated virtual audits both as internal auditors and as auditees.

This training will be useful for students interested in supporting eventual certification for their organizations and students focused on efficient management during recovery.

Risk Based thinking, Risk Management, and Risk Mitigation

Internal Audit Techniques:

• Internal Audit Results to Improve Process
• Effectiveness and Risk Mitigation.
• Virtual Audit: Techniques and Conduct
• Part 1: Audit Simulations

RISK BASED THINKING, RISK MANAGEMENT, AND RISK MITIGATION (4-hours)

• Enhanced management
• Process improvement
• Due diligence as part of organization transfer
• Supply chain management
• Organization certification effort

INTERNAL AUDIT TECHNIQUES (4-hours)

• Setting goals for the internal audit
• Audit planning
• Audit scheduling
• Selection and training of internal auditors
• Types of internal audit
• Internal auditor preparation
• Conducting the internal audit
• Presenting and managing non-conformances
• Documenting the internal audit
• Reporting results of the internal audit

INTERNAL AUDIT RESULTS TO IMPROVE PROCESS EFFECTIVENESS AND RISK MITIGATION. (4-hours)

VIRTUAL AUDIT (4-hours)

• Techniques and Conduct
• risks to the organization performing the audit
• risks to the organization being audited
• advantages and disadvantages of virtual audits
• the role of virtual audits in supply chain
  management

PART 1: AUDIT SIMULATIONS (4-hours)

Trainees will have the opportunity to perform an internal audit. They will be given simulated case studies for use during these audits. A post audit Analysis will be given.

Introduction/Objectives

ISO 9001:2015 is an international standard primarily meant to streamline processes, improve product/ service quality with an aim to enhance customer satisfaction

The modules in this training program (details are on next page) is structured so as to allow:

• Students/businesses to get a basic understanding of the intent and benefits of implementing the ISO standards
• Align key business processes with the requirements of the standard that will ultimately help in process definition, implementation, and measurement of key process metrics
• Risk identification/assessments — methods to mitigate risks
• Increase profitability by eliminating waste, reducing cost and an increase in margins

Module 1 : Awareness Session/Overview (4 hours)

• Background/Context: Relevance of ISO 9001:2015 to small/mid sized companies
• Alignment of the standard with the business model of the company
• Implementing ISO 9001 – Impact to the business, bottom line improvements, Benefits
• Concept of PDCA Differences with ISO 9001:2008 – Terminology ,new clauses etc
• Certification to ISO 9001 – The Process, role of Certification Bodies etc

Module 2 : Gap Analysis (4 hours)

• Understanding the requirements/clauses in the ISO standard
• First cut view of the gaps relative to implementing the standard
• Identification of key processes, process owners, metrics etc
• Leverage any existing work already done ie Documents, Training etc
• Resource Estimation: Time /Effort requirements to fix the gaps, High level Project PlanLeadership Commitment, Core team etc

Module 3 : Identification of key business processes aligned with the business model of the company (4 hours)

• Interaction of Process Flow chart: Development,Alignment, Approvals
• Process Definition
• Input/Output Diagrams with corresponding metrics
• Documentation structure: Typical Four layer structure,focus on “lean” documentation
• QMS Map : Map of processes with different levels of documentation as applicable

Module 4 : Quality Policy/Quality Objectives(4 hrs)

• Quality Policy: Development, Agreement, Approvals, Alignment with the strategy of the company
• Quality Objectives: First cut view of Non Financial Metrics
• Balanced Score card
• Financial vs Non Financial Metrics
• Defining Targets/Goals for each objective: Past performance, Customer needs etc
• Competitive analysis

Module 5 : Risk Analysis/Assessments (4 hrs)

• Concept of Business Risk vs Process Risk
• SWOT analysis
• Context of the Organization log (COTO log): Identification of issues/concerns/risks for key stakeholders
• Use of Risk Assessment Tools: FMEA, FTA etc
• Documentation, Communication, Training to all process owners on risks to the business/process , mitigation strategies

Introduction/Objectives

ISO 13485:2016 is an international standard primarily meant to streamline processes, improve product/ service quality with an aim to enhance customer satisfaction fundamentally in the medical industry

The modules in this training program (details are below) are structured so as to allow:

• Students/businesses to get a basic understanding of the intent and benefits of implementing the ISO standards
• Align key business processes with the requirements of the standard that will ultimately help in process definition, implementation, and measurement of key process metricsRisk identification/assessments — methods to mitigate risks
• Focus on specific requirements from the Regulatory bodies
• Increase profitability by eliminating waste, reducing cost and an increase in margins

Module 1 : Awareness Session/Overview (4 hours)

• Background/Context: Relevance of ISO 13485:2016 to small/mid sized companies
• Alignment of the standard with the business model of the company
• Implementing ISO 13485 – Impact to the business, bottom line improvements, Benefits
• Concept of PDCA
• Differences with ISO 13485:2003 – Terminology, new clauses etc
• Certification to ISO 13485 – The Process, role of Certification Bodies etc
• Regulatory Bodies (FDA) – Roles, Understanding FDA Requirements etc

Module 2 : Gap Analysis (4 hours)

• Understanding the requirements/clauses in the ISO 13485standard
• First cut view of the gaps relative to implementing the standard
• Identification of key processes, process owners, metrics etc
• Leverage any existing work already done for ISO 9001 ie Documentation, Training etc
• Resource Estimation : Time/Effort requirements to fix the gaps, High level Project Plan
• Leadership Commitment, Core team etc

Module 3 : Identification of key business processes aligned with the business model of the company (4 hours)

• Interaction of Process Flow chart: Development, Alignment, Approvals…Tweak Existing IOP if available
• Process Definition,
• Input/ Output Diagrams with corresponding metrics
• Documentation structure: Typical Four layer structure, focus on “lean” documentation – Modify/Tweak as needed to align with 13485
• QMS Map : Map of processes with different levels of documentation as applicable

Module 4 : Quality Policy/Quality Objectives(4 hrs)

• Quality Policy: Development, Agreement, Approvals, Alignment with the strategy of the company, Tweak as needed
• Quality Objectives: First cut view of Non Financial Metrics Balanced Score card
• Financial vs Non Financial Metrics
• Defining Targets/Goals for each objective: Past performance, Customer needs etc – leverage from ISO 9001 work already done
• Competitive analysis

Module 5 : Risk Analysis/Assessments (4 hrs)

• Concept of Business Risk vs Process Risk
• Use of Risk Assessment Tools : FMEA, FTA etc – only as needed
• Documentation, Communication, Training to all process owners on risks to the business/process , mitigation strategies
• Alignment with any FDA regulated risks and risk treatment methods

Management will continue to face unique challenges in a post COVID-19 world. These five (5) management skills will be put to the test, Leadership; Change & Upheaval; Engaging Employees; Communication; Delegating & Coaching Employees.

Modified training format to address business needs in a COVID-19 environment.

Leadership in the COVID-19 Crisis (4-hours)

Ensure leaders are prepared to handle the challenges a post-COVID business environment will present.

Change and Upheaval as It Relates to the COVID-19 Crisis (4-hours)

Providing the skills that leaders need to remain empathetic during these chaotic times for employees while also remaining a productive manager.

Engaging Employees in a Crisis (4-hours)

Train leadership to successfully engage employees and inspire the workforce to contribute to an organization’s goals.

Communicating in the COVID-19 Workplace (4-hours)

Educating leadership about communication in a COVID-19 environment. Find out what needs to improve or change and how to accomplish this goal.

Delegating and Coaching Employees During the COVID-19 Crisis (4-hours)

See how to help employees reach their full potential. This training will help management create an agile and flexible working environment.

LEADERSHIP IN THE COVID-19 CRISIS (4-hours)

With all uncertainty that exists due to the aftermath of the Coronavirus, we as Leaders need to be prepared to handle challenges that will impact our business. These challenges will include how to deal with new procedures, suppliers, changing shifts and in some cases, creating new products. During this four-hour webinar, we will discuss what Leadership will look like going forward in a post COVID-19 environment.

CHANGE AND UPHEAVAL AS IT RELATES TO THE COVID-19 CRISIS (4-hours)

Employees are dealing with so much chaos as it relates to the COVID-19 crisis. Leaders need to keep in mind that employees are also dealing with struggles at home. From schooling their children, to loss of jobs of their family members, shopping for essentials and keeping their families healthy. Being empathetic is critical but we also need to remind them that change is necessary for us to go forward in both our work and personal lives. When employees begin to understand that we all are experiencing this, they tend to be not as anxious. We all must understand also, that while some people respond negatively to change others feel a positive excitement. Those are the individuals who can help us bring along the others.

ENGAGING EMPLOYEES IN A CRISIS (4-hours)

Employee engagement is what makes employees want to contribute to the organization’s goals. Employee engagement is why companies are successful, because their people feel connected to the organization and are happy to be apart of it. There are those companies that were not strong in this area before the crisis. While there is no miracle to fix it overnight, this could be a time of opportunity to grow in this area. In order to do this and move toward an environment that promotes employee engagement, companies need to enhance their communication strategy. They need to show the employees that their health and safety is the top priority of the organization. Now is the time more than ever to listen to the employees and allow them to voice not just their concerns but also their ideas. Studies have proven that when individuals are allowed to give an opinion (even if their opinion is not used but given consideration) they are most likely be committed to the task at hand. Employees feel much more respected and valued when they are able to have a voice.

COMMUNICATING IN THE COVID-19 WORKPLACE (4-hours)

There is no such thing as overcommunicating in a COVID-19 environment. With change and updates coming at a rapid pace communication critically matters. Leaders need to keep in mind that how they communicate, where they communicate, and their communication vehicle is just as important in how they deliver the message. Speaking assertively, choosing the proper words, tone and body language is so important during this time. Especially since so many individuals have so much anxiety and fear in this situation. Where the communication is carried out is also important. Does the message need to be delivered in a small setting or is the large venue more effective? As far as delivering the message, one needs to understand that email may not always be the proper vehicle and at times face to face conversation is more appropriate.

DELEGATING AND COACHING EMPLOYEES DURING THE COVID-19 CRISIS (4-hours)

Helping employees reach their full potential is important for employee engagement. Now is not the time to let that take a backseat. During a crisis time companies need to shift their way of doing business as usual. Now is the time we need for our employees to be agile and embrace new ways of doing things. At times they will feel they are not ready, which is why a Leader must take the proper approach. At this time a leader must step into and not away from the development of their people. This is a time to teach new skills for everyone including the Leader. The Leader must delegate and coach their people so that the Leader themselves may learn and grow into new responsibilities and opportunities. This program will teach why it will be important to delegate tasks but also how to set one up for success in the situation. Coaching is also discussed to correct mistakes and to encourage the employee to be accountable for themselves.

Past experience has demonstrated that the Sales and Business Management approach is most successful when all key leaders and functional heads from the client organization are in attendance and engaged for the full duration of all five 4-hour sessions. There will also be advanced preparation and follow-ups required of many of the participants in order to ensure success of the program.

In 2018 the FDA announced its intentions to harmonize the FDA Quality System Regulation [QSR] Title 21 CFR Part 820 with ISO 13485:2016. This supports their participation in the global program Medical Device Single Audit Program [MDSAP]. This session reviews the differences between QSR and ISO and how the MDSAP will become more critical and cost effective in the future.

BIOMATERIAL AND BIOPHARMACEUTICAL OVERVIEW OF MANUFACTURING 4.0 [4 Hours]

These next generation of therapies and devices will be discussed and how New Jersey plays a critical part in these cutting-edge technologies. This session will cover the some of the developments in both areas and differences between them and current pharmaceuticals and devices. There will also be a discussion on how Manufacturing 4.0 will play a vital role in the growth of these technologies.

INTERNAL AUDITING AS THE KEY TO REGULATORY COMPLIANCE [4 Hours]

Regardless of quality management system followed, the internal auditing program of the processes and procedures used in the manufacturing operation is critical for compliance. This session will discuss the various internal auditing requirements of cGMP regulations and ISO standards and give examples of compliant and non- compliant programs.