Creating High-Performing Teams: Leadership and Team Development. -By AtoZ Compliance

Key Take Away:

This advanced management program webinar will enhance your leadership and corporate strategic planning skills to inspire and influence your team members to achieve your goals as a team.

Overview:

Inspire and influence your team members to achieve your goals as a team!

Managers who will be promoted are the ones who not only manage efficiently but also lead their teams effectively. Learn how to work in a horizontal mode of operation…apply a consistent theory in leading your team…and teach critical leadership development skills to members of your team, so each one of them can lead the team in your absence.

Why Should You Attend:

Know when to use organizational strategic planning and when to lead your team
Project management training and reality based leadership to clearly visualize your goals and communicate them to your team
Identify your market’s needs to better target your team’s efforts through strategic business planning process
Help your team find creative solutions to workplace challenges
Develop a high-performance team
Use effective communication to motivate and coach
Areas Covered In This Webinar:

Would you like to learn more about the differences between leading and managing?

What about understanding how to more clearly visualize your goals and communicate them to your team?

How about being able to better target your team’s efforts?

Would you like your team to improve performance?

If you answered “yes” to any of these questions, then come laugh, listen and learn as Chris DeVany leads usall through those important topics, key questions and answers we all need to be able to address effectively to improve our team members’ and team’s performance.

 

Learning Objectives:

Understanding leadership style and the situation
Integrating your leadership and managerial roles
Examining the leader’s role as motivator and coach and in high-performance teams
Distinguishing the three team types
Exploring the principles that make teams work
Differentiating team content and process
Diagnosing work-teams: a work-team simulation

Who Will Benefit:

CEOs
Executives
Senior Managers
Managers

For more information, please visit : http://bit.ly/2lRlGhG
Email: support@atozcompliance.com
Toll Free: +1- 844-414-1400
Tel: +1-516-900-5509

Speakers Profile:

Chris DeVany
Chris DeVany is the founder and president of Pinnacle Performance Improvement Worldwide, a firm which focuses on management and organization development. Pinnacle’s clients include such organizations as Microsoft, Visa International, the Society for Human Resource Management (SHRM), U.S. Department of Housing and Urban Development, Sprint, American Counseling Association, Aviva Insurance, U.S. Patent and Trademark Office, Big Brothers and Big Sisters, Hospital Corporation of America, Schlumberger, Morgan Stanley, Boston Scientific, US HealthCare and over 500 other organizations in 22 countries.

He has published numerous articles in the fields of project management, management, sales, team-building, leadership, ethics, customer service, diversity and work-life balance, in publications ranging from ASTD/Performance In Practice to Customer Service Management. His McGraw-Hill book, “90 Days to a High-Performance Team”, is replete with hands-on tools, templates and checklists which managers use effectively everyday to improve performance.

He has appeared hundreds of times on radio and television interview programs to discuss project management, sales, customer service, effective workplace communication, management, handling rapid personal and organizational change and other topical business issues. He has served or is currently serving as a board member of Sales and Marketing Executives International, American Management Association, American Society of Training and Development, Institute of Management Consultants, American Society of Association Executives, Meeting Professionals International and National Speakers Association. Chris is an award-winning Toastmaster’s International Competition speaker. He recently participated in the Fortune 500 Annual Management Forum as a speaker, panelist and seminar leader.

Chris has distinguished himself professionally by serving Corporate America as manager and trainer of project management, IT, sales, customer service and marketing professionals. Included among those business leaders are Prudential Insurance, Sprint, BayBank (now part of Bank of America), US Health Care and Marriott Corporation. He has assisted these organizations in developing project management, sales, customer service and marketing strategies, organizing inbound and outbound call center programs, training and development of management and new hires, and fostering corporate growth through creative change and innovation initiatives.

Chris holds degrees in management studies and organizational behavior from Boston University. He has traveled to 22 countries and 47 states in the course of his career.

 

Understanding and Implementing a Technology Transfer Process – By AtoZ Compliance

Key Take Away:

This course is designed for people tasked with developing, filing, and manufacturing pharmaceutical products especially small molecule oral dosage forms. This includes individuals that have responsibilities for formulation development, scale-up, filing, and commercial manufacture of dosage forms as well as maintaining the high quality of those products.

Overview:

Successful transfer of pharmaceutical products and their processes is critical to the successful launch. Its success ensures that products of the highest quality are delivered to the patients along with meeting the business demands of the company. However, execution of that transfer is complex involving the interactions of many disciplines across an organization. It depends both on the careful development, management, and transfer of technical and business knowledge along with the development of steps to define the formal transfer of that knowledge from R&D documents and systems to commercial manufacturing documents and systems.

Why Should You Attend:

This technology transfer training will introduce the concepts associated with implementing a carefully defined technical and business governance programs along with clearly defined R&D to site transfer steps for successful implementation.

Areas Covered In This Webinar:

Technology Transfer principles discussed include

The importance of technology transfer
The use of a technical review system to update and review technology knowledge obtained during drug product development
The use of a Product Strategy Review system to review important business aspects in preparation for transfer
Tools and Templates used for technology transfer

Learning Objectives:

The purpose of this training is to provide you with an overview of the Technology Transfer

At the end of the session, you should be able to:
Define technology transfer
Identify elements of the business process framework for managing technology transfers
Identify New Product transfer process
Explain benefits of technology transfer
Determine elements of a successful technology transfer

Who Will Benefit:

Following personnel will benefit from the course:

Senior quality managers
Quality professionals
Regulatory professionals
Compliance professionals
Production supervisors
Manufacturing engineers
Production engineers
Process owners
Quality engineers
Quality auditors
Development professionals
Senior development managers

For more information, please visit : http://bit.ly/2qeYZpX
Email: support@atozcompliance.com
Toll Free: +1- 844-414-1400
Tel: +1-516-900-5509

Speakers Profile:

Steven Laurenz
Steven Laurenz– Chemical Engineering M.S. – Michigan State University

Expertise: Over 25 years of technical leadership experience in product development, process development, technology transfer, and process optimization. Skilled in taking new products from early laboratory stage to successful manufacturing launch. Expert in integrating Quality by Design and risk management into product development. Experience in establishing a Quality System for a R&D Quality Assurance organization.

Experience: Headed product development departments at Abbott Laboratories and AbbVie Inc. Leadership positions in numerous technical consortiums.

Other: Black Belt certified in Business Excellence and Master Certificate in Applied Statistics

Lessons Learned in Computer System Validation: A Project Manager’s Perspective -By AtoZ Compliance

Key Take Away:

This pharmaceutical validation training reviews the requirements for computer validation, including the industry-accepted collection of documentation which constitutes a validation package.

Overview:

Computer system validation (sometimes called computer validation or CSV) is the process of documenting that a computer system meets a set of defined system requirements. Validation of computer systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records is a critical requirement of electronic record compliance, as described in the FDA 21 CFR 11.10(a) and EMA Annex 11, Section 4.

The webinar will discuss user requirements, functional specifications and design specifications, requirement traceability, risk assessment, creating appropriate testing protocols, summary reports, and how to maintain your validated systems, skewed towards the information a Project Manager needs to develop an executable project plan.

Why Should You Attend:

Every pharmaceutical manufacturing facility utilizes Computer Systems, and for a Project Manager, these systems may be foreign to them. Even though there is a saturation of training on what Computer System Validation is, there is little training for a Project Manager to discover what the key elements of a project plan MUST be to support a successful project completion. Countless hours are wasted explaining PLC and HMI and how procedural controls are important to their use, as well as software and hardware requirements. The lessons learned in this webinar are intended to help a Project Manager (or anyone involved with capital projects) to recognize, address and mitigate those real risks associated with computer system validation, the NUMBER ONE cause of schedule slippage on many projects.

Areas Covered In This Webinar:

Project Initiation and Planning

Project Management
Software Development Life Cycle (SDLC) Process Definition
Gap Assessments
Risk Assessments
Validation Master Planning (VMP)
System Requirements and Design

User Requirements Specifications (URS)
Functional Specifications (FS)
Design Specifications (DS)
Design Review
Supplier/Vendor Audits
System Development and Verification

Leveraging of Vendor Documentation
Unit Testing
Integration Testing
System Testing
Factory Acceptance Testing (FAT)
Site Acceptance Testing (SAT)
Installation Qualification (IQ)
Operational Qualification (OQ)
Performance Qualification (PQ)
Requirements Traceability
System Operation

Backup and Recovery
Data Archiving
Continuity Planning
Disaster Recovery
Change and Configuration Management
Incident and Problem Management
Periodic System Reviews
Best Practices Training
FDA 21 CFR 11.10(a) and EMA Annex 11, Section 4
GAMP 5
Risks to project scope, schedule and budget
Computer System Validation basics
Critical issues related to CSV on large capital projects
Finally, REAL WORLD lessons learned from a half dozen installation will be presented. For each of these, the presentation will discuss cause and effect.
Learning Objectives:

Computer System Validation is an area foreign to most capital projects Project Managers. This webinar will present REAL WORLD lessons learned from the management of dozens of projects in the area of Pharmaceutical Manufacturing Facility construction.

A detailed description of typical requirements will be presented, but more importantly, this webinar will address what that means to a Project Manager and the Project Team. It will give introduction to critical issues and discuss and present case study lessons learned.
Who Will Benefit:

Quality Assurance

Engineering

Operations

Manufacturing

Validation

Project Management

Maintenance

For more information, please visit :  http://bit.ly/2rPaoOj
Email: support@atozcompliance.com
Toll Free: +1- 844-414-1400
Tel: +1-516-900-5509
Speakers Profile:

Keith Gibbs
Mr. Gibbs is a highly motivated leader with a proven project management track record. Able to interface with and motivate people at all levels of an organization or project and across all business units, he works diligently on the application of best practices. He possesses an extensive experience organizing and supervising the business activities of project teams, within budget and to tight timetables. An innovative thought leader who is well respected by industry peers for creative and applicable solutions to complex problems, he has proven planning and brainstorming expertise that has established a framework for successful projects and business practices.

Mr. Gibbs is a sought after trainer and educator who has a gift for motivating fellow professionals to reach their peak performance. Through many years of in the field experience, he possesses a full and applied understanding of the business of consultancy support to industry.

As the owner of Ninja Project Management, Mr. Gibbs relies on his eighteen years of experience in Project Management, Engineering, Construction Management, Commissioning & Qualification (Verification), Validation, Quality Assurance, and Pre-Operations Management Support for the pharmaceutical, biotechnology, semiconductor and utility generation and transmission industries, to help clients succeed. Typically, responsible for the management of cGMP or specialty projects that involve start-up, commissioning, qualification and validation, he is best utilized for short-term, fast track, complex projects. His greatest strength is applying his expertise to projects that need to be brought back on track, and he is a recognized leader for project salvage and restoration planning. To support these tasks, he is involved in the preliminary design review, constructability review and master planning activities to ensure the integration of all phases of a project in the support of turnover, start-up, Quality Assurance and Validation requirements.

In his career, he has managed the design, installation, start-up and qualification of utility, facility, control and process systems for laboratories and pharmaceutical manufacturing facilities. A leader in the integrated approach to commissioning and qualification, he has extensive experience in authoring and executing test plans and protocols. A unique specialty is the development of leveraged Factory Acceptance Test (FAT) and Site Acceptance Test (SAT) plans as part of integrated Commissioning/Validation efforts. Another hard earned specialty is the extensive experience in deviation resolution.

Mr. Gibbs has managed teams from 2 to 40 direct reports on projects from $50,000 to $50,000,000. He has supported innovative projects with full life-cycle involvement, as well as task focused short cycle assignments.

In his free time, he runs a small business, Raleigh Llama Salvage and Restoration, where he seeks out and restores items and artefacts of interest to him. He is an avid disc golfer and enjoys time with his family.

Criminal Background Checks in the Hiring Process-By AtoZ Compliance

Key Take Away:

You can do your due diligence and conduct legally compliant criminal background checks, and if you attend this webinar, you will learn how to do both.

Overview:

This webinar will help you understand and appreciate the legal issues you must be aware of and discuss some Best Practices so that you can increase your protection – on all fronts!

Why Should You Attend:

Most of your employees are likely to be honest, reliable employees. At the same time, hiring employees always involves at least some risk. Are they honest? Are they reliable? Are you, your employees and the public safe if you hire them? Hopefully your worst hire was simply someone who underperformed or wasn’t a match for your company. What if it’s worse, though? What if an employee unfortunately becomes violent with co-workers or unsuspecting members of the public, or steals from you or others? You can then be liable for negligent hiring or retention of those employees if a criminal background check would have revealed this information. On the other hand, the federal Equal Employment Opportunity Commission and Consumer Financial Protection Bureau and many of their state and local counterparts are scrutinizing if, how and when you may conduct and use information you obtain from criminal background checks in the hiring process.

Government agencies concerned about equal employment opportunity for ex-offenders and for minorities have moved to restrict how and when employers may conduct and use information obtained background checks from a criminal background check when they are looking to hire employees. The federal Consumer Financial Protection Bureau and some of their state counterparts also have something to say about how and when you can conduct criminal background checks as part of your hiring process. Used properly, a criminal background check can be an invaluable tool in your decision-making process. If you do not make sure your background checks are legally compliant, however, you could find yourself facing a lawsuit or an investigation from a federal or state government agency. If you do not conduct a background check at all, you could be exposing yourself to liability for negligent hiring/retention. These do not have to be your choices! You can conduct a background check that protects you from negligent hiring liability and keeps you under government radar

Areas Covered In This Webinar:

Why You Should Conduct Criminal Background Checks.

What is Negligent Hiring/Retention, Cases of Negligent Hiring/Retention
What is the Fair Credit Reporting Act (FCRA)?

How do you comply with the FCRA?
Cases involving the FCRA

Fair and Accurate Credit Transactions Act (FACTA)

Equal Employment Opportunity Commission’s (EEOC) position on criminal background checks

EEOC’s pre-2012 guidelines

EEOC’s 2012 Enforcement Guidance

EEOC Cases

“Ban the Box” Laws

Other considerations (workplace safety/violence issues, workers’ comp).
Learning Objectives:

You will learn how to conduct criminal background checks that comply with the Fair Credit Reporting Act and EEOC guidelines. You will also learn, generally, how to be compliant with “Ban the Box” laws.
Who Will Benefit:

CEO’s, Hiring Managers, Recruiters, H.R. Directors, H.R. Managers, Senior Management, people in the background screening industry.
For more information, please visit : http://bit.ly/2p65E5n
Email: support@atozcompliance.com
Toll Free: +1- 844-414-1400
Tel: +1-516-900-5509

Speakers Profile:

Janette Levey Frisch
Janette Levey Frisch, Founder of The EmpLAWyerologist Firm, has over 20 years of legal experience, more than 10 of which she has spent in Employment Law. It was during her tenure as sole in-house counsel for a mid-size staffing company headquartered in Central New Jersey, with operations all over the continental US, that she truly developed her passion for Employment Law.

Janette and The EmpLAWyerologist Firm operate under this core belief: It is possible, and it is in an employer’s best interest, to proactively solve workforce challenges before they become problems, before they result in lawsuits or steep fines caused by government audits.

Janette works with employers on most employment law issues, acting as the Employer’s Legal Wellness Professional — to ensure that employers are in the best position possible to avoid litigation, audits, employee relations problems, and the attendant, often exorbitant costs.

Janette authors the firm’s weekly blog, where you can read each week, in plain English (not legalese) about issues impacting employers today. Janette has written articles on many different employment law issues for many publications, including EEO Insight, Staffing Industry Review, @Law, and Chief Legal Officer.

Janette is a member of the Workplace Violence Prevention Institute.

Janette has also spoken and trained on topics, such as Criminal Background Checks in the Hiring Process, Joint Employment, Severance Arrangements, Pre-Employment Screening among many, many others.

Operational Audit – The Basics-By AtoZ Compliance

Key Take Away:

Internal Audit has the responsibility to evaluate those controls through the operational auditing process to determine if they are adequate and effective.

Overview:

This class is designed to give you the basics for doing an operational audit. We will discuss management and audit concepts to help you understand how the process works. We will also do some exercises to further strengthen your knowledge.

Why Should You Attend:

Every organization has a primary business objective, the reason for its existence. Whether it is a “for-profit” organization or a “not-for-profit” organization, there is always a primary business objective. And each organization is set up to accomplish that primary business objective.

The primary business objective is the life blood of the organization. And management has the responsibility to set up an operational structure and processes to ensure that the primary business objective is accomplished. However, to do that, there are so many other secondary objectives that have to be achieved. For example, management has to establish various departments like an:

HR Department– to hire/train personnel
Procurement Department – to purchase material/goods
Accounting Department – to pay vendors and employees
IT Department – to leverage technology
Maintenance Department – to care for equipment/infrastructure
There are numerous other possible departments depending on the company and its primary business objective. And every department has its own departmental objectives to directly or indirectly support the primary business objective. And management has the responsibility to establish controls to ensure that these objectives are achieved.

Areas Covered In This Webinar:

Definitions

IIA internal audit
Operational audit
The three primary types of audits

Financial
Compliance
Operational
Management’s responsibilities

Plan, organize, lead, and control
Establish an organizational structure
Establish objectives that directly or indirectly support the primary mission
Assess the risk of not achieving the objectives
Establish controls to ensure that the objectives are achieved
Gain an understanding of the operational audit process which includes

Develop an annual audit plan
Conduct a preliminary survey of the selected area
Determine the audit objectives
Determine the audit scope
Conduct an entrance conference
Conduct the field work
Conduct exit conference
Communicate the Results to Management
Follow up on audit findings
Key IIA Standards relative to operational audits

2010 – Planning
2201 – Planning Considerations
2220 – Engagement Scope
2240 – Engagement Work Program
2300 – Performing the Engagement
2400 – Communicating Results
2500 – Monitoring Progress

Learning Objectives:

Operational auditing plays an important role in helping management achieve its primary business objective.
Who Will Benefit:

Audit Managers
Staff Auditors
Government Auditors
Compliance Auditors
Internal Control Specialists
Public Accountants
Accounting Analysts
Business Analysts
Quality Control Specialists

For more information, please visit : http://bit.ly/2orlCZF
Email: support@atozcompliance.com
Toll Free: +1- 844-414-1400
Tel: +1-516-900-5509

Speakers Profile:

Jonnie Keith
Jonnie Keith has been in auditing for over 40 years. He retired in 2012 as the assistant general manager (AGM) of internal audit with the Metropolitan Atlanta Rapid Transit Authority (MARTA) in Atlanta, GA. He served in that capacity for over 10 years and was responsible for administering their overall audit activities. He was also responsible for the review and approval of all internal audit correspondence including audit reports, executive summaries, internal and external correspondence, etc.

Prior to that, he worked at MARTA as the operational audit manager and senior contract compliance auditor. He also worked at Norfolk Southern Railway (Southern Railway) as a senior operational auditor and started his career at the Federal Reserve Bank of Atlanta as a bank examiner.

Mr. Keith received a BA degree in economics from Clark Atlanta University (formerly Clark College). His certifications include: Certified Internal Auditor (CIA), Certified Fraud Examiner (CFE), Certified Government Auditing Professional (CGAP), and Certified Internal Control Auditor (CICA).

He has been a volunteer seminar instructor for the National Office of the Institute of Internal Auditors for several years and has taught numerous classes including: audit report writing, communication skills for auditors, advanced operational auditing, leadership skills for auditors, CIA review course, and more.

Fair Housing: What Everyone Should Know. -By AtoZ Compliance

Key Take Away:

This fair housing act training webinar will give you the tools needed so that you may be in compliance and not be subject to the ramifications of a fair housing investigation by HUD.

Overview:

The entire fair housing training webinar will be covering all aspects of fair housing. The goal is for the attendee to learn all about fair housing so that they will be completely informed on all the housing discrimination laws, rules, regulations and penalties involved so they may be in compliance. This will include the “basics” as well as delve into the various specialized topics that come up.

Why Should You Attend:

Fair housing violations can cost upwards of $100,000. We will give you the tools needed so that you may be in compliance and not be subject to the ramifications of a fair housing investigation by HUD.

Areas Covered In This Webinar:

Basic Fair Housing training for owner, managers, and the public
Fair Housing for maintenance staff
Reasonable accommodation
Recent cases
Assistance animals
Latest rulings from HUD concerning:
VAWA
Criminal background check
Limited English proficiency
Harassment
Non-smoking

Learning Objectives:

Learn all about Fair Housing
Be completely informed on all the rules, regulations and penalties involved
How to be in compliance

Who Will Benefit:

Property Managers
Property owners
Maintenance Staff
Leasing consultants
Housing Authority Staff
Auditors
Attorneys
Law Enforcement
Tenant Associations
Board of director members of condo association boards
For more information, please visit : http://bit.ly/2lf1KZR
Email: support@atozcompliance.com
Toll Free: +1- 844-414-1400
Tel: +1-516-900-5509

Speakers Profile:

Paul Flogstad
Paul Flogstad has been involved in the real estate industry for over 38 years, including sales, construction, project management, appraisal, property management, consulting, and training.

Through his consulting company, Property Management Solutions, Paul provides training and consulting services nationwide to owners, management companies, multi-housing associations, as well as state and federal agencies.

Paul specializes in fair housing issues and has developed fair housing and outreach programs for governmental agencies and seminars that he presents to property management companies, apartment associations, and the general public nationwide. As a consultant to the State of South Dakota, Paul developed a ground-breaking fair housing awareness program that makes use of an ombudsman concept, which has proven effective in dealing with discrimination and landlord/tenant issues.

Paul holds numerous professional property management designations and currently holds the prestigious RHM designation from the National Center for Housing Management.

Paul was previously Vice President of the South Dakota Multi-Housing Association, Vice Chairman of the Minnehaha County Housing and Redevelopment Commission, and Chairman of the Sioux Falls Property Appeals Board.

In 2009, he received the Outstanding Educator of the Year award from the South Dakota Multi-Housing Association.

Supply Chain and Product Compliance Using RoHS, REACH, and Conflict Minerals -By AtoZ Compliance

Date: June 15th Thursday
Time: 01:00 PM EDT | 10:00 AM PDT
Duration: 60 Minutes
Product Code: 300287
Level: Intermediate

 

Key Take Away:

This Supply Chain Compliance program will offer an in-depth look at three important product regulations focused on materials compliance and ethical sourcing, along with the tools and policies needed to implement them.

Overview:

Today’s corporations are faced with many challenges when it comes to designing, manufacturing, and distributing their products around the world. With over 10,300 environmental regulations globally, limited budget and resources, companies need to focus on the regulations that cover the broadest territory and encompass the strictest standards. In order to prevent stop shipments, fines, and fees, companies must align key regulatory requirements with programs throughout the supply chain.

Why Should You Attend:

The European Union and the United States are leading the world in product regulations focused on environmental compliance and ethical sourcing. Compliance is mandatory in order to continue manufacturing, shipping, and selling products in Europe and the U.S. It is required that companies comply with the use laws and limits for each material, along with documenting the appropriate due diligence, and completing the mandatory government reporting requirements.

Areas Covered In This Webinar:

Overview of three of the most important materials regulations, the processes, and the programs needed
RoHS 1 and 2 Compliance
REACH Compliance
US Dodd-Frank Conflict Minerals Reporting
Improving data collection by using Jig 101, IEC 62474, IPC 1752
Managing suppliers with procurement contracts
Effectively using technology for tracking and managing compliance

Learning Objectives:

This webinar will illustrate why, as the number of monitored substances continues to rise, it is important for companies to develop the programs, processes, and tools that will help prevent future enforcement actions.
Who Will Benefit:

This webinar will provide valuable assistance to all personnel in:

Product design
Supply chain compliance
Responsible sourcing
Supply chain risk management
Environmental compliance
Social compliance and auditing
Corporate social responsibility

Level:
Intermediate

For more information, please visit :  http://bit.ly/2qO1fXH
Email: support@atozcompliance.com
Toll Free: +1- 844-414-1400
Tel: +1-516-900-5509
Speakers Profile:

Kelly Eisenhardt
Kelly Eisenhardt is Co-Founder and Managing Director of BlueCircle Advisors responsible for business development, consulting, and training services focused on environmental compliance and corporate social responsibility.

Her experience working in technology and sustainability roles for companies such as EMC, PTC, and Fair Factories Clearinghouse have given her a strong foundation to create compliance programs, build sustainability and reporting programs, implement data collection technologies, and manage initiatives that identify CSR risk in facilities, products, and supply chains. She is a writer for industry trade publications such as EnvironmentEnergyPro, CSRwire, CSR@Risk, and an invited guest blogger at Triple Pundit on trends in compliance, supply chain, and sustainable product development.

BlueCircle Advisors is a social good consultancy in CSR Risk Management focused on helping companies make environmentally safe products, reducing carbon footprint by using less energy, and instituting fair working conditions in global supply chains.