Leadership Management Academy 201-202: Rising Through the Management Ranks 2017

 

Overview:

Why Should You Attend?

By attending, you will take advantage of a great opportunity to advance as a manager to the next level!

Too often, we focus on getting things done and results and miss working on our self-development. Let’s face it: this is how we get paid yet this is also how we keep falling behind when it comes to our careers. It’s time to get ahead! Don’t miss an opportunity to advance as a manager again!

We’ll take you through peer discussions addressing leading and managing, integrating finance and quality, managing your time effectively, managing performance and managing up.

Join us as we help you report back to your manager that “I’m ready to take the next step in advancing my management career!”

 

Why should you attend :

By attending, you will understand how to even more effectively:

  • Lead and manage
  • Integrate finance and quality in your organization
  • Manage your time, including prioritizing
  • Manage performance
  • Understand behavioral styles, so you can manage more effectively
  • Handle performance conversations, especially difficult conversations
  • Coach with purpose and focus
  • Manage to Action Plans, both by your team members and yourself
  • Build teams
  • Integrate performance improvement and quality improvement
  • Manage your manager, manage up

Are you concerned about getting ahead, taking the next step in your management career, yet you never seem to have the time?

Would you like to get a better handle on those difficult “performance conversations” you have to have?

Would it make a difference if you could coach more effectively with purpose and focus?

Would you like to improve your management skills to the point where everyone on your team is taking action to achieve results every day?

If you answered “yes” to any of these questions, then come laugh, listen and learn as Chris DeVany leads us all through these important topics, key questions and answers we all need to be able to address effectively to improve our team members’ and team’s performance, all of which helps us manage even more affectively and rise up the corporate ladder!

Areas Covered in the Session:

Leading and Managing

    • Coping with new roles as leaders
    • The differences between leading and managing
    • Leading effectively – best practices
    • Managing effectively – best practices

Integrating Finance and Quality in Our Organization

    • Quality Management
      • How are we managing quality in our organization?
      • Best practices
      • Improving quality and quality management
    • Quality and Cost – Drive down labor and supply costs while improving the quality of products and service provided
    • Management Integration – Find the right structure, align incentives, and engage managers in business and process improvements.
    • Revenue Cycle – Implement the cultural, process, technology, and talent strategies that will get better results with limited resources.
    • Budgeting — Planning, Implementing and Evaluating

Managing Time Effectively / Prioritizing

    • How we can be more efficient and effective
    • Determining priorities and focusing on the important (time management/delegation)
    • LEM goals
    • Managing increasingly multiple priorities and working relationships

Managing Performance

    • Understanding Behavior, Managing Performance Within a Behavioral Context
      • Behavioral styles – how can we quantify behavior interactions with customers and with co-workers
      • Evaluating behavior
        • Understanding behavioral tendencies (DiSC – Dominant, Influencing, Steady and Cautious) and addressing when reviewing performance
    • Performance Conversations, Difficult Conversations
    • How to have those conversations with employees (crucial performance conversations)
    • Coaching and mentoring – especially with those who are under-performing
      • Why might people not be performing well – understanding and addressing
      • Integrating coaching with performance conversations.
    • Action Planning
    • Follow-up to those conversations
      • Monitoring the Action Plan
      • Modeling the behavior we expect
      • Monitoring and reviewing of Action Plans
    • Performance Reviews
      • Working with HR for conducting performance reviews objectively
      • Managing and implementing Professional Development Plans (PDPs)
      • The importance of documenting performance
      • Letting someone go legally and professionally while protecting yourself at the same time
    • Integrating Performance Improvement and Quality Improvement
      • Taking this to the next level – follow-through – continuing that improvement
    • Team-Building
      • Keeping the environment positive while effectively managing performance
      • Supporting employee morale and job satisfaction – tips and techniques we can use
      • Building/sustaining a cohesive team – accountability
  • Managing Up
    • Managing your manager
    • Dealing with senior management
    • Managing new and evolving working relationships – how do you push back without pushing back
    • Persuasion influencing, (up) and negotiating up

 

Who will benefit:

  • CEO
  • Senior Vice President
  • Vice President
  • Executive Director
  • Managing Director
  • Regional Vice President
  • Area Supervisor
  • Manager

 

 

 

Agenda:

Lecture 1: Leading and Managing

Lecture 2: Integrating Finance and Quality – Part 1

Lecture 3: Integrating Finance and Quality – Part 2

Lecture 4: Managing Time Effectively – Part 1

 

Day 2 Schedule

Lecture 1: Managing Time Effectively – Part 2

Lecture 2: Managing Performance – Part 1

Lecture 3: Managing Performance – Part 2

Lecture 4: Managing Your Manager, Managing Up

 

 

Speaker:

Chris DeVany,

Founder and President, Pinnacle Performance Improvement Worldwide,

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 global organizations such as Visa International, Cadence Design Systems, Coca Cola, Sprint, Microsoft, Aviva Insurance, Schlumberger and over 500 other organizations in 22 countries. He also has consulted to government agencies from the United States, the Royal Government of Saudi Arabia, Canada, Cayman Islands and the United Kingdom.

He has published numerous articles in the fields of surviving mergers and acquisitions, surviving change, 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 book, “90 Days to a High-Performance Team“, published by McGraw Hill and often accompanied by in-person, facilitated instruction, has helped and continues to help thousands of executives, managers and team leaders improve performance.

He has appeared hundreds of times on radio and television interview programs to discuss mergers and acquisitions (how to manage and survive them), 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 the International Association of Facilitators, 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 multiple corporations as manager and trainer of sales, operations, project management, IT, 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 mergers and acquisitions, facilitating post-merger and acquisition integration, 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.

 

 

Location: Raleigh, NC Date: April 27th & 28th, 2017 and Time: 8:30 AM to 5:30 PM

 

 

Venue: Courtyard Raleigh-Durham Airport

Address:  Courtyard Raleigh-Durham Airport   2001 Hospitality Ct, Morrisville, NC 27560, United States

 

Price:

 

Register now and save $200. (Early Bird)

 

Price: $1,195.00 (Seminar Fee for One Delegate)

 

Until March 15, Early Bird Price: $1,195.00 From March 16 to April 25, Regular Price: $1,395.00

 

Register for 5 attendees   Price: $3,585.00 $5,975.00 You Save: $2,390.00 (40%)*

 

Quick Contact:

NetZealous DBA as GlobalCompliancePanel

161 Mission Falls Lane, Suite 216, Fremont,CA 94539, USA

Phone: 1-800-447-9407

Fax: 302-288-6884

Email: support@globalcompliancepanel.com

Website: http://www.globalcompliancepanel.com

Registration Link – http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900866SEMINAR?wordpress-SEO

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GlobalCompliancePanel announces Seasonal offers for Professionals with Flat 50% OFF on all Seminars

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Do celebrations need a cause and a reason? Yes, and GlobalCompliancePanel, a leading provider of professional trainings for the regulatory compliance areas, is having a solid cause and reason for doing so. It is celebrating the many years of its relationship with its customers spread all over the world by offering its trainings at a massive 50% discount!

Yes, that is right. GlobalCompliancePanel’s seminars will be available for a huge 50% discount till April 30. Regulatory professionals who want to augment their knowledge of regulatory compliance can now do so by paying just half the price of these trainings from GlobalCompliancePanel. All that is needed to do walk away with a rare offer such as this is to visit https://www.globalcompliancepanel.com/seminar?wordpress_SEO and use MGCP50 Promo Code.

This offer is valid till April 30, 2017. Regulatory professionals who want to take any of GlobalCompliancePanel’s trainings can book their trainings for an area of their interest by this date. From April 1 onwards, this offer will cease, meaning that the original price will apply from then.

So, why is GlobalCompliancePanel offering this discount? It is for a simple, but profound reason: It wants to thank its huge customer base for the support they have been extending to this company over the many years for which it has been in business. During the course of the 10 years for which GlobalCompliancePanel has been in business, it has trained thousands of regulatory compliance professionals from around the world.

These professionals, belonging to such varied geographies as the US and Japan and India and Canada, have been able to meet their regulatory compliance challenges on account of these trainings. These trainings are relevant, focused and valuable, and are from some of the best known regulatory compliance Experts found anywhere on this planet.

It is these trainings that have been hoping these professionals in the regulatory compliance arena gain more insights into regulations from the FDA, the EMA and other such bodies around the world. These trainings have been consistently helping them to meet these challenges, as they give them a better and sharper understanding of the implementing these requirements.

These regulatory requirements can pose hurdles to the most experienced and brightest of regulatory compliance professionals in the medical devices, pharmaceutical, life sciences and food and biologicals areas, but not to those who undertake professional trainings from GlobalCompliancePanel. GlobalCompliancePanel’s panel of experts is here to help them overcome these challenges and hurdles.

This trend has been being witnessed from the time GlobalCompliancePanel entered the line of professional trainings. Any wonder then, that no fewer than 50,000 professionals have benefited from these trainings? What could be a better way of thanking such a huge base of customers than with this offer? GlobalCompliancePanel believes that a celebration should also be useful, and this is that this offer is!

Hurry up and enroll today. Happy learning!

 

 

Management systems should be built on expansiveness and versatility

Management systems should be built on expansiveness and versatility. Only such a system delivers results for an organization. First of all, let us get a basic understanding of a management system: It is a system that helps smoothens and streamlines an organization functioning, enabling it to go on without hiccups.

The purpose of a management system is to put the organization on the road to the destination it has chosen for itself. This is done by instilling a system in which there are a defined set of prescriptive and hierarchical documents, and are well-defined. A prudent management system is one that enables the organization to carry out a host of dispersed functions and activities, so that time and resources are spared.

What an organization’s management system should address is an important question. Ideally, it should consist of a set of standards and practices that addresses all the aspects of the organization’s safety, health and environment management. Such a management system greases the whole process and brings efficiency, consistency, cost-effectiveness and timeliness into it.

A pivot for health and environment management systems

Businesses that use their assets for setting up and creating inputs for the various standards around the functions are effective ones. This is a proven and effective method of optimizing the efficiency of management systems, and becomes the foundation on which decisions concerning the way resources are spent within the Safety, Health & Environment (SH&E) scope of business are made. That is, a management system that becomes a hinge around which an array of functions can be performed is an efficient and effective one.

A proper management system has safety, health and environment at its core. The key to build an SH&E system that is designed along these lines is being able to first thoroughly evaluate their requirements. Organizations also need to have the farsightedness to anticipate the likely changes that could go into these functions over time. The management systems they build must have the strength, resilience and flexibility to absorb these changes. An organization that builds an SH&E system that fails to take these into account is doomed to failure and is sure to be a huge financial burden.

What can a management system that takes SH&E into consideration achieve?

The benefits of building an SH&E-accommodated management system are many. It can be used to or helps in:

o  Identifying everything that has to be managed within the function

o  Constructing a mechanism, tool, or process that manages each of those things identified. These are normally a set of standards, practices and programs that are built specifically for a particular function

o  Building the standard, practice or program so that it can be adjusted according to results

o  Building a measuring metric, benchmark or scorecard with both lagging and leading indicators

o  Building the management system in a way that is hierarchal in structure within the organization – (corporate sets and standards and the business unit builds the practice around the standard)

More on how to build a sound SH&E management

GlobalCompliancePanel, a leading provider of professional trainings for the regulatory compliance areas, will organize a two-day seminar in which the principles to adapt and the thinking needed to cultivate the outlook for building such a management system will be imparted.

The Director of this seminar is James J. Thatcher, President and Owner, Global Safety Solutions LLC., who is listed as an expert witness for operational, as well as safety, health, environmental, training and security issues in the Oil and Gas industry and the mining, minerals and chemical industry. Please register for this seminar by visiting http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900844SEMINAR?linkedin_SEO .

This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

In-depth exploration of SH&E management systems

At this seminar, James will make an in-depth exploration of management systems in the health and environmental areas. A complete understanding of SH&E, plus Training and Security (TS), which are the functions around which standards and practices are built, will be offered. He will also offer a description of the 16 functions that cover the SHE & TS world in detail. This learning is important in helping participants understand ways by which to build a standard and practice around all these 16 functions.

The 16 functions that will have a standard and practice specific to the function are:

o  Hazard identification & control

o  Occupational health & industrial hygiene

o  Incident management

o  Emergency preparedness

o  Environmental

o  Regulatory compliance

o  Reporting performance

o  Managing risk

o  Managing safety

o  Management security

o  Verification & audits

o  Document & record management

o  Contractor & service provider management

o  Competency management (training)

o  Commitment, communication and implementation

o  Managing change

In addition, in order to enable clear understanding of the topics, James will also describe the role of supporting documents, associated programs, procedures or Standard Operating Procedures (SOP) that are a part of the particular function being managed,.

GlobalCompliancePanel Professional Training and Development Courses with Flat 50% OFF on all Seminars

Do celebrations need a cause and a reason? Yes, and GlobalCompliancePanel, a leading provider of professional trainings for the regulatory compliance areas, is having a solid cause and reason for doing so. It is celebrating the many years of its relationship with its customers spread all over the world by offering its trainings at a massive 50% discount!

Yes, that is right. GlobalCompliancePanel’s seminars will be available for a huge 50% discount till March 31. Regulatory professionals who want to augment their knowledge of regulatory compliance can now do so by paying just half the price of these trainings from GlobalCompliancePanel. All that is needed to do walk away with a rare offer such as this is to visit http://www.globalcompliancepanel.com/ and use MGCP50 Promo Code.

This offer is valid till March 31, 2017. Regulatory professionals who want to take any of GlobalCompliancePanel’s trainings can book their trainings for an area of their interest by this date. From April 1 onwards, this offer will cease, meaning that the original price will apply from then.

So, why is GlobalCompliancePanel offering this discount? It is for a simple, but profound reason: It wants to thank its huge customer base for the support they have been extending to this company over the many years for which it has been in business. During the course of the 10 years for which GlobalCompliancePanel has been in business, it has trained thousands of regulatory compliance professionals from around the world.

These professionals, belonging to such varied geographies as the US and Japan and India and Canada, have been able to meet their regulatory compliance challenges on account of these trainings. These trainings are relevant, focused and valuable, and are from some of the best known regulatory compliance Experts found anywhere on this planet.

It is these trainings that have been hoping these professionals in the regulatory compliance arena gain more insights into regulations from the FDA, the EMA and other such bodies around the world. These trainings have been consistently helping them to meet these challenges, as they give them a better and sharper understanding of the implementing these requirements.

These regulatory requirements can pose hurdles to the most experienced and brightest of regulatory compliance professionals in the medical devices, pharmaceutical, life sciences and food and biologicals areas, but not to those who undertake professional trainings from GlobalCompliancePanel. GlobalCompliancePanel’s panel of experts is here to help them overcome these challenges and hurdles.

This trend has been being witnessed from the time GlobalCompliancePanel entered the line of professional trainings. Any wonder then, that no fewer than 50,000 professionals have benefited from these trainings? What could be a better way of thanking such a huge base of customers than with this offer? GlobalCompliancePanel believes that a celebration should also be useful, and this is that this offer is!

Hurry up and enroll today. Happy learning!

GMPs for API Bulk Manufacturers

Till recently, till 2001 that is, Good Manufacturing Practices for Active Pharmaceutical Ingredients (APIs) bulk manufacturers was carrying a bulky load on its shoulders, so to speak. GMP for active pharmaceutical ingredients (APIs) per se had no independent guidelines. The GMPs that they were to follow and implement were bunched with those of APIs for bulk manufacturers. So, GMPs for API bulk manufacturers consisted of GMPs for both APIs and API bulk manufacturer.

All that changed, however, in 2001, with the FDA’s issuance of a draft guideline called Q7A, which was meant separately and exclusively for APIs alone. This draft guideline was meant solely for APIs, and GMPs for API bulk manufacturers were exempt from the provisions of the new guideline.

No clear guideline yetThat said, while the FDA draft guidance of 2001 merely separated GMPs for APIs; it did not make any changes to the existing GMPs for API bulk manufacturers, which continued to remain the same and continued to suffer the same insufficiency. The major deficit that plagued GMPs for API bulk manufacturers continued to do so. As in the past, there was no guideline on GMPs for API bulk manufacturers at all. Instead, all that was required was that bulk manufacturers go by their heart. In other words, the onus of maintaining GMPs for API bulk manufacturers was left to them, based on their unique individual needs and situations.

Leaves it to the individual pharma organizationThe FDA and other regulatory bodies merely require that established practices be followed as GMPs for API bulk manufacturers. This, as noted, leaves the task of ensuring that conception and implementation of all-round GMPs for API bulk manufacturers to the individual organization, based on its discretion and assessment of what it deems as appropriate. The following are the areas into which pharmaceutical organizations may take steps at implementing GMPs for API bulk manufacturers:

  • Manufacturing equipment
  • Components that go into the materials and packaging
  • Requirements relating to record-keeping
  • Facilities and buildings
  • Personnel
  • Process controls
  • Laboratory controls

Learn more on this topic for your reference: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900964SEMINAR?Linkedin-SEO

Validation of Pharmaceutical Water Systems

validation-of-pharmaceutical-water-systems1

Thorough and proper validation of pharmaceutical water systems is highly essential for ensuring that the pharmaceutical unit uses the right quality of water. This is very important, because water is not only the source of life for humans; it enjoys the same importance in pharmaceuticals.

A very important reason for which validation of pharmaceutical water systems is necessary is that water is not only the most widely used raw material or substance in pharmaceuticals; it is also put to a number of uses in the pharmaceutical industry, such as Quality Control, process, production and formulation. Further, water comes with its own set of unique chemical properties that are obtained because of the hydrogen bonds present in it and its polarity. This makes water versatile, since it allows the dissolution, absorption, adsorption or suspension of various different compounds.

Process for pharmaceutical water systems validationvalidation-of-pharmaceutical-water-systems

Validation of pharmaceutical water systems is carried out in three phases:

Phase I, which is the investigational phase

Phase II, the short term control phase, and

Phase III, which is the long-term control phase

Pharmaceutical water systems are validated through these three steps or stages to demonstrate and ensure that the facility using pharmaceutical water systems has water under its control and is on the right track for production of the right quality and quantity of water in the short, medium and long terms.

Validation through commissioning and qualificationPharmaceutical water systems validation is carried out through two important steps, namely commissioning and qualification. Commissioning is about putting the validation of pharmaceutical water systems through the required phases using the prerequisite methods of documentation. This documentation is a core part of pharmaceutical water systems validation because it allows for different personnel in the organization to not only keep track of the processes involved, but also make changes when necessary.

Qualification as part of pharmaceutical water systems validationQualification is the next important stage of pharmaceutical water systems validation. Here, before a pharmaceutical water systems validation process is started, the pharmaceutical facility should implement the following important steps:

  • Design qualification (DQ)
  • Installation qualification (IQ) and
  • Operational qualification (OQ)

Phase I:In Phase I, the pharmaceuticals facility samples and tests water sampling for anywhere between two and four weeks for monitoring the water system. If the water system is free of failure during this phase, it is considered a successful phase of pharmaceutical water systems validation.

Phase II:In this phase of pharmaceutical water systems validation too, the water system sample is tested intensively for two to four weeks, during which the water sample should show that it is producing the right quantity of water under conditions of stated SOP.

Phase III:Phase III of pharmaceutical water systems validation is the longest and most arduous period, running to one year after completion of Phase I and Phase II. When the water sample passes through this phase, it is said to have completed the process of pharmaceutical water systems validation and is considered fit for pharmaceutical use.

Learn more on this topic by visiting : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900882SEMINAR?wordpress-SEO

Supplier Management Conference for Medical Device Manufacturing in HONG KONG

 

Overview:

Supplier selection and management is one of the critical issues for medical device manufacturers. Suppliers provide materials and services to the device manufacturer, which means that they can be critical to performance and delivery of your device. Neither the FDA nor your notified body regulates your suppliers (with a few exceptions). They expect you to have an effective process to ensure your suppliers perform in the regulatory environment.

How well do you understand the requirements for supplier management?

Could you pass a regulatory audit or inspection without any issues?

This course delivers the tools, templates, and methods to help participants implement an effective and efficient supplier management program.

This two-day hands-on course provides a clear understanding of the underlying principles of supplier management. The course uses exercises to solidify understanding. In addition, the course uses FDA Warning Letters to illustrate the points and help you learn from others. As part of the practical implementation, the course includes receiving acceptance activities, outsourced processes, process validation at the suppliers’ location, supplier auditing techniques, and supplier issues in management review.

The course uses the Global Harmonization Task Force (GHTF) framework, but expands it to cover other issues and techniques important in effective implementation.

Why should you attend:

Since FDA regulations do not allow them to audit your suppliers unless they make finished medical devices, they require that you have sufficient control over them. But from time to time the FDA makes a reinterpretation of what this means. This happened within the last f 5 years, so if you supplier management program is older than that, you need to make major changes in you supplier management program. This is why the Good Manufacturing Practice (aka Quality System Regulations) is called cGMP. The C stands for current, meaning what the FDA considers the current state of the art in the areas they regulate. Also European Notified Bodies also periodically update their expectations, and for suppliers this happened with the publication of a guidance document by the Notified Body Operations Group (NBOG).

This seminar will go into the details of the NBOG supplier guidance document and a GHTF (Global Harmonization Task Force) guidance that describes the current FDA expectation on supplier management.

One of the major things introduced in these guidance document, is the concept of Risk, and the use of identified risks as part of the evaluation and monitoring of suppliers.

This seminar will review requirements and expectation of the FDA and European Notified Bodies for supplier management, and then how to incorporate these into your own supplier management process.

Areas Covered in the Session:

  • Understand FDA QSR and ISO 13485 requirements for supplier management
  • Creating a Risk-based Multi-tier supplier classification system
  • Understand when suppliers have to register and list with the FDA
  • Defining and using supplier Metrics
  • Explain the link between design control and purchasing data
  • Develop an risk-based supplier management process
    • Incorporating supplier regulatory and safety risk
    • Incorporating supplier business risk
  • Create supplier measurement and monitoring systems
  • Understand the how to develop and implement supplier controls
  • Create a risk based Value-added system for supplier audits
  • How to prepare yourself and your contract manufacturer for unannounced audits from your Notified body
  • Creating acceptance criteria and understand how that fits into your supplier control process

Who will benefit:

  • Quality Managers
  • Quality Engineers
  • Audit Managers
  • Supplier Engineers
  • Internal quality auditors
  • Supplier auditors
  • Quality associates
  • Quality Specialists
  • Regulatory Compliance Managers

Agenda:

Day 1 Schedule

Lecture 1:

Introductions

Lecture 2:

Fundamentals Regulatory Requirements

  • FDA Requirements
  • ISO 13485 requirements
  • Understanding the role of the Global Harmonization Task Force Guideline
  • Understanding NBOC Guideline and why it should be used

Lecture 3:

Planning the Supplier Management Program

  • Supplier Classification
  • Supplier QA agreements what are they and why are then

Day 2 Schedule

Lecture 1:

Planning Supplier Selection

Lecture 2:

Potential Suppliers

Lecture 3:

Supplier Selection

Lecture 4:

Implementing Supplier Controls

Lecture 5:

Monitoring, Measuring, and Evaluation

  • Periodic Monitoring
  • Re-evaluations

Lecture 6:

Supplier Audits – where do they add value

  • Planning your supplier audit schedule
  • How Notified Body unannounced audits affect your contract manufacturer
  • What you should do to prepare yourself and your contract manufacturer for unannounced Notified body audits

Lecture 7:

Feedback and Communication

  • Supplier meetings: Partnering with Key suppliers
  • Supplier Corrective Actions

Lecture 8:

Evaluating your current program to see how it measures up to regulatory Expectations

Speaker:

Betty Lane,

Founder and President, Be Quality Associates, LLC

Betty Lane has over 30 years’ experience in Medical Device quality assurance and regulatory affairs. She is the founder and President of Be Quality Associates, LLC, a consulting company helping small and medium sized medical device and diagnostic companies implement and improve their quality systems. Her work enables companies to manage their business in compliance with FDA and ISO 13485 requirements, as well for quality system requirements for other geographic area such as Europe and Canada. Her background in digital systems engineering enables her to facilitate quality system processes for design controls and software validation. Her areas of expertise include training, auditing, supplier management, document and records management, design controls, and software validation.

Betty’s training experience includes over 25 years of training on all aspects of ISO 13485, the ISO standard for Medical Device – Quality Management Systems – System Requirements for regulatory purposes, and FDA Quality System Regulation – Medical Devices; Good Manufacturing Practice (cGMP), in companies where she worked as manager or director, and for AAMI, ASQ biomedical division, and ASQ sections. She has taught courses in medical device and biotechnology quality and regulatory affairs as an Adjunct at Northeastern University, Boston, MA. Betty is active in her local section of the American Society for Quality and is also a member of the Association for the Advancement of Medical Instrumentation (AAMI), The Society of Women Engineers and the IEEE. Betty has degrees in engineering from Rensselaer Polytechnic Institute (RPI), and an MBA from Northeastern University.

Location: Hong Kong Date: April 6th & 7th, 2017 and Time: 9:00 AM to 6:00 PM

 

Venue: INTERCONTINENTAL HONG KONG

Address: 18 Salisbury Road, Kowloon, Hong Kong

 

Price:

 

Price: $1,695.00 (Seminar Fee for One Delegate)

 

Until February 28, Early Bird Price: $1,695.00 from March 01 to April 04, Regular Price: $1,895.00

 

Register for 5 attendees   Price: $5,085.00 $8,475.00 You Save: $3,390.00 (40%)*

 

Quick Contact:

NetZealous DBA as GlobalCompliancePanel

 

Phone: 1-800-447-9407

Fax: 302-288-6884

Email: support@globalcompliancepanel.com

Website: http://www.globalcompliancepanel.com

Registration Link – http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900878SEMINAR?channel=mailer&camp=seminar&AdGroup=wordpress_April_2017_SEO

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