Description

Overview: Negative customer feedback about a medical device's performance or safety is a strong indicator of whether a firm's manufacturing process is in control. This feedback is therefore subject to many requirements in both the QSR and ISO 13485. Failure to follow up on complaints about medical devices is among the most frequently cited observations on FDA-483s. This session will include the requirements for defining, documenting, and implementing a complaint-handling system, including the requirements for complaint review, investigation, and corrective action, as well as the ISO-specific implications. This session will discuss the best way to document customer feedback, what constitutes a complaint, and what do with "non-complaint" feedback. Also contained will be a suggested method on including complaint trending into your firm's CAPA program. Additionally, the application of risk management to a complaint handling system will be reviewed, and a specific risk management system explained.

Areas Covered in the Session

- FDA and ISO requirements for complaint handling

- Establishment of complaint handling program

- What constitutes a complaint

- ISO-specific implications of complaint handling

- The roles of investigation and corrective action in complaint handling

- Complaint trending and reporting

- Application of risk management to complaint handling program

Who will benefit: (Titles)

This webinar will provide valuable assistance to all regulated companies, since complaint handling is a regulatory requirement across the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:

· Regulatory Management

· QA Management

· Customer Service Personnel

· Sales Personnel

· Quality System Auditors

· Consultants

About Speaker

Jeff Kasoff, RAC, is the Director of Quality at Byrne Medical, a leading manufacturer of endoscopy products. In this position, Jeff is responsible for supplier management, during which he oversees supplier management, CAPA, and document control. Prior to this, Jeff spent 13 years at Life-Tech as the Director of Regulatory Affairs, where he was responsible for regulatory compliance of all aspects of the quality system. Jeff received his regulatory affairs certification in 1996.

Price List: Live: $189.00 One Dial In - Unlimited attendance $249 Recorded: $289.00, CD: $349.00
For any assistance contact us at support@compliance2go.com or call us at 877.782.4696

Description

The HIPAA rules for Privacy and Security of Protected Health Information are undergiong significant expansion, with new requirements, fines, and penalties, and a new enforcement effort.

Why should you Attend:

The HIPAA privacy and security regulations are changing in ways that affect every health care-related entity, from providers to insurers to business associates, and more. The HIPAA Privacy and Security Regulations have been modified in regulations issued as interim final rules (IFRs) and notices of proposed rule making (NPRMs) by the US Department of Health and Human Services (USDHHS).

• All kinds of covered entities, and now, business associates of covered entities and their subcontractors as well, need to review their HIPAA compliance, policies, and procedures to see if they are prepared to meet the changes in the rules. Some subcontractors of business associates may not even be aware that they handle protected health information and now fall under the regulations.

• A whole range of new regulations around the release and accounting of electronic records have created new burdens that your EHR and your medical records department must deal with.

• Not only are the compliance rules changed, but the enforcement rules have changed, with a new four-tier violation schedule with increased minimum and maximum fines, and mandatory fines for willful neglect of compliance that start at $10,000 even if the problem is corrected within 30 days of discovery. Violations that are not promptly corrected carry mandatory minimum fines starting at $50,000 and can reach $1.5 million for any particular violation. And any reports of willful neglect are required to be investigated under the law. Even violations for a reasonable cause or with reasonable diligence taken are subject to penalty.

• Whereas the former practice of USDHHS has been to audit compliance only in instances where a violation was reported, the law now requires USDHHS to conduct a regular HIPAA compliance audit program, and soon those individuals harmed by a violation will have the right to a share in any settlements or penalty collections. The new audit program is already getting under way.

• With the far reaching changes in the rules and the new enforcement and penalty levels, it’s never been more important to review your HIPAA compliance and meet the new requirements.

Description of the topic:

• New regulations modifying the HIPAA Privacy and Security Regulations have been proposed and/or finalized to meet the privacy and security mandates within the HITECH Act in the American Recovery and Reinvestment Act of 2009. New requirements for business associates of HIPAA covered entities and requirements to notify individuals in the event of a breach are only two of the many areas affected in the new law, including new requirements for restricting and accounting of disclosures and increased enforcement activity.

• All kinds of covered entities, and now, business associates of covered entities and their subcontractors as well, need to review their HIPAA compliance, policies, and procedures to see if they are prepared to meet the changes in the rules. Covered entities that use electronic health records (EHRs) will need to meet new access and disclosure rules and all kinds of business associates and their subcontractors will need to establish compliance programs.

• And the regulations include new requirements for audits by the US Department of Health and Human Services and mandatory penalties in the event of willful neglect of the regulations.

• This teleconference will help health information professionals understand what they have to do, and when, and what to keep in mind as they move forward, in order to be prepared for compliance with the new regulations. It will provide a comprehensive look at the changes in the law and prepare attendees for the process of incorporating the changes into how they do business in their facilities.

• Business associates are now directly covered by the HIPAA privacy, security, and breach notification regulations and are liable for fines and penalties if they do not comply. In addition, there are new kinds of businesses that are considered to be business associates, such as Health Information Exchanges and e-Prescribing Gateways,as well as patient safety organizations and any subcontractors of business associates, putting thousands of businesses under regulation that were not regulated before now. We will explain what a Business Associate needs to do differently under the new regulations, including providing a policy framework for information security.

• Penalties for violations have been increased, including a new, four-tier penalty structure and new mandatory penalties for willful neglect that begin at a minimum of $10,000 and can go up to $1.5 million or more. The definitions of the penalty levels include new definitions for reasonable cause and reasonable diligence, as well as willful neglect, which have a direct impact on the amount of penalty a violation may be subject to.

• Electronic records have new demands placed on them, in both providing access and in accounting for all disclosures of health information – the electronic age in health care brings new obligations to serve individuals as well as manage health information for healthcare professionals. We will discuss how disclosures must be tracked in an EHR and review the various ways patient records can be supplied electronically.

• The new regulations will be reviewed and their effects on usual practices will be discussed, as will what policies need to be changed and how. We will show what policies and evidence you need to produce if you are audited by the HHS Office of Civil Rights. Now that there is a legislative mandate to audit compliance, and a random audit plan under development, you need to be prepared to respond to audit requests.

Areas Covered in the Session:

The new regulations change the way individuals have access to their records, and how much they can find out about who has accessed their records.

Individuals can now request certain restrictions on disclosures that you must honor.

There are new requirements for disclosers of health information to apply “minimum necessary” standards.

Business Associates have new requirements to comply with HIPAA privacy protections and security safeguards and are subject to enforcement and penalties directly by HHS.

Health Information Exchanges, Regional Health Information Exchanges, and e-Prescribing gateways are now considered to be Business Associates

New limitations on marketing and fund-raising may change how entities can reach out to individuals.

New audit and penalty requirements increase the need to make sure you are in compliance before HHS OCR knocks on the door.

o Learn how changes to HIPAA came to pass

o Find out the details of the changes to HIPAA, including new definitions

o Understand how the changes affect your organization

o Plan for implementing new requirements

o Learn how to attain compliance

o Find out about new penalties and enforcement of HIPAA

o Discover the Changes to HIPAA Practices in the areas of:

A. Business Associates

B. Breach Notification

C. Accounting of Disclosures

D. Restriction of Disclosures

E. Enforcement, Audits, and Penalties

Who will benefit

Compliance director

CEO

CFO

Privacy Officer

Security Officer

Information Systems Manager

HIPAA Officer

Chief Information Officer

Health Information Manager

Healthcare Counsel/lawyer

Office Manager

Contracts Manager

About Speaker

Jim Sheldon-Dean is the founder and director of compliance services at Lewis Creek Systems, LLC, a Vermont-based consulting firm founded in 1982, providing information privacy and security regulatory compliance services to a variety of health care providers, businesses, universities, small and large hospitals, urban and rural mental health and social service agencies, health insurance plans, and health care business associates. He serves on the HIMSS Information Systems Security Workgroup, has co-chaired the Workgroup for Electronic Data Interchange Privacy and Security Workgroup, and is a recipient of the 2011 WEDI Award of Merit. He is a frequent speaker regarding HIPAA and information privacy and security compliance issues at seminars and conferences, including speaking engagements at AHIMA national and regional conventions and WEDI national conferences, and before the New York Metropolitan Chapter of the Healthcare Financial Management Association, Health Information Management Associations of Virginia, New York City, New York State, and Vermont, the Connecticut Hospital Association, and the Hospital and Health System Association of Pennsylvania. Sheldon-Dean has nearly 30 years of experience in policy analysis and implementation, business process analysis, information systems and software development. His experience includes leading the development of health care related Web sites; award-winning, best-selling commercial utility software; and mission-critical, fault-tolerant communications satellite control systems. In addition, he has eight years of experience doing hands-on medical work as a Vermont certified volunteer emergency medical technician. Sheldon-Dean received his B.S. degree, summa cum laude, from the University of Vermont and his master’s degree from the Massachusetts Institute of Technology.

Price List: Live: $189.00 One Dial In - Unlimited attendance $249 Recorded: $289.00, CD: $349.00
For any assistance contact us at support@compliance2go.com or call us at 877.782.4696

Description

Since 1984, the FDA has identified lack of design controls as one of the major causes of device recalls.

The SMDA provided the FDA with the authority to add preproduction design controls to the device GMP regulation.

The design control requirements are not intended to apply to development of concepts and feasibility studies.

Preamble #62

FDA will evaluate the process, the methods, and the procedures that a manufacturer has established to implement the requirements for design controls.

The FDA has amended the IDE regulation, reaffirming that an IDE device is exempted from complying with the GMP’s … with the exception of Sec. 820.30 “Design Controls.”FDA will not inspect design controls during bioresearch monitoring inspections.The concept of an environmental management system evolved in the early nineties and its origin can be traced back to 1972, when the United Nations organised a Conference on the Human Environment in Stockholm and the United Nations Environment Programme (UNEP) was launched (Corbett & Kirsch, 2001). These early initiatives led to the establishment of the World Commission on Environment and Development (WCED) and the adoption of the Montreal Protocol and Basel Convention.

In 1992, the first Earth Summit was held in Rio-de-Janeiro (Jiang & Bansal, 2001), which served to generate a global commitment to the environment (RMIT University). In the same year, BSI Group published the world's first environmental management systems standard, BS 7750.[1] This supplied the template for the development of the ISO 14000 series in 1996, by the International Organization for Standardization, which has representation from committees all over the world (ISO) (Clements 1996, Brorson & Larsson, 1999). As of 2010, ISO 14001 is now used by at least 223 149 organizations in 159 countries and economies.

Why should you Attend

In the global economy and supplier partnership, it is critical that every product development process for product, service or logistics, is well design - that the design inputs are well defined, design outputs are documented and auditable as well as design transfers are successful. There are millions of dollars spent on design transfers that are not effective - and instead of creating a benefit and remove liability, they instead increase the liability and risk. They have been number of FDA finds and warning letters issued against the design control processes to all sizes of medical and pharmaceutical manufactures. This topic is becoming ever increasing as we are being pressured to design faster, transfer faster, make faster yet never compromised quality, compliance, risk, or profit.

Areas Covered in the Session:

- Medical Device, FDA & CFR

- Design Control Introduction

- Design & Development Planning

- Design Input

- Design Output

- Design Review

- Design Verification

- Design Validation

- Design Transfer

- Design Changes

- Design History File

Who will benefit:

- Quality Managers

- EHS managers

- Small business owners

- CAPA investigators

- Project managers

- Product development engineers

- Consultants

Free Handouts: Medical Device, FDA & CFR

Meet You Speaker:

Salim Khan: He holds a master degree in Manufacturing Engineering, an MBA and BS in Mechanical Engineering. He is also ASQ certified Six Sigma Black Belt, Certified Reliability Engineer, Certified Quality Engineer. Salim has successfully implemented several design control and risk management processes for medical device companies. He also has extensive experience in developing efficient product development process. He enjoys statistics and has completed several process validations.

About Speaker

Jasmin NUHIC serves a major medical devices OEM as a Sr. Engineer and 21 CFR Part 11 Subject Matter Expert. He also served ASQ section as a chair for two consecutive terms, has taught quality certification exam prep course, completed numerous software validations and obtained over 25 different certifications in leadership, quality, software validations, and more. Jasmin NUHIC has conducted Webinars on this and other topics with high attendance and appreciation. More information about Jasmin NUHIC can be found by visiting his profile on LinkedIn.

Price List: Live: $189.00 One Dial In - Unlimited attendance $249 Recorded: $289.00, CD: $349.00
For any assistance contact us at support@compliance2go.com or call us at 877.782.4696

description

Attendees will receive free document on Review of ISO14001 standard; review of ISO 9001 standard - learn similarities nd differences.

"The ISO 14000 environmental management standards exist to help organizations minimize how their operations (processes etc.) negatively affect the environment (i.e. cause adverse changes to air, water, or land); comply with applicable laws, regulations, and other environmentally oriented requirements, and continually improve in the above.

The concept of an environmental management system evolved in the early nineties and its origin can be traced back to 1972, when the United Nations organised a Conference on the Human Environment in Stockholm and the United Nations Environment Programme (UNEP) was launched (Corbett & Kirsch, 2001). These early initiatives led to the establishment of the World Commission on Environment and Development (WCED) and the adoption of the Montreal Protocol and Basel Convention.

In 1992, the first Earth Summit was held in Rio-de-Janeiro (Jiang & Bansal, 2001), which served to generate a global commitment to the environment (RMIT University). In the same year, BSI Group published the world's first environmental management systems standard, BS 7750.[1] This supplied the template for the development of the ISO 14000 series in 1996, by the International Organization for Standardization, which has representation from committees all over the world (ISO) (Clements 1996, Brorson & Larsson, 1999). As of 2010, ISO 14001 is now used by at least 223 149 organizations in 159 countries and economies

Description of the Topic:

Overview of the regulation, its benefits to organizations, elements of auditing for ISO 14001, training requirements, awareness, and implementation, some of the lessons learned and most commonly asked questions.

Areas Covered in the Session

- Overview of the standard

- Implementation tips and suggestions

- Benefits of implementation and compliance

- Auditing elements related to ISO 14001

- Increasing awareness and communications

- Lessons learned

Who will Benefit

- Quality Managers

- EHS managers

- Small business owners

- CAPA investigators

- Project managers

- Operations managers

- Consultants

- Review of ISO14001 standard; review of ISO 9001 standard - learn similarities and differences

About Speaker

Jasmin NUHIC serves a major medical devices OEM as a Sr. Engineer and 21 CFR Part 11 Subject Matter Expert. He also served ASQ section as a chair for two consecutive terms, has taught quality certification exam prep course, completed numerous software validations and obtained over 25 different certifications in leadership, quality, software validations, and more. Jasmin NUHIC has conducted Webinars on this and other topics with high attendance and appreciation. More information about Jasmin NUHIC can be found by visiting his profile on LinkedIn.

Price List: Live: $189.00 One Dial In - Unlimited attendance $249 Recorded: $289.00, CD: $349.00
For any assistance contact us at support@compliance2go.com or call us at 877.782.4696
https://www.compliance2go.com/index.php?option=com_training&speakerkey=8...

description

Document control can be a time- and paper-consuming process. Even the simplest of changes often requires an inordinate amount of time spent in the preparation, submission, distribution, and implementation of change requests, document modifications, document review meetings, document approvals, and document placement. Many companies can spend MUCH LESS time and prepare MANY LESS documents, and still be in compliance with the regulations. This presentation will review the QSR and ISO requirements for document control, and provide a streamlined process for document control. Records maintenance, distribution, and management can be similarly streamlined by this system.

Areas Covered in the Session

- QSR and ISO 13485 requirements for document control

- Description of typical document control system in use

- Streamlined document control process

- Paper-free document review

- Immediate document distribution

Who will benefit: (Titles)

The employees who will benefit include:

· Executive Management

· Document Control Management

· Document Control Clerks

· Consultants

· Quality system auditors

About Speaker

Jeff Kasoff, RAC, is the Director of Quality at Byrne Medical, a leading manufacturer of endoscopy products. In this position, Jeff is responsible for supplier management, during which he oversees supplier management, CAPA, and document control. Prior to this, Jeff spent 13 years at Life-Tech as the Director of Regulatory Affairs, where he was responsible for regulatory compliance of all aspects of the quality system. Jeff received his regulatory affairs certification in 1996.

Price List: Live: $189.00 One Dial In - Unlimited attendance $249 Recorded: $289.00, CD: $349.00
For any assistance contact us at support@compliance2go.com or call us at 877.782.4696
https://www.compliance2go.com/index.php?option=com_training&speakerkey=8...

Description

Why Should You Attend:

This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Latin America. The primary countries covered will include: Argentina, Brazil and Mexico. Other countries such asChile, Costa Rica, Dominican Republic, Panama, Peru and Venezuela will be discussed. The course will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in Latin America. Content will include descriptions of the methods by which regulators in the corresponding agencies process filings and registrations and what is expected in the authorization and dossier maintenance of licensed products.

The current regulatory climate in Latin America is discussed in detail and several examples will be provided to illustrate effective compliance procedures and techniques. Common issues that have caused difficulties for Life Sciences firms in the region are outlined. Course content will explain how Latin America interacts with and utilizes ICH standards and how they relate with other national regulatory agencies. Additionally, participants will learn how personnel can best address the conflicts, which arise and the best course for resolution.

Agenda: (All time in EST)

1:00 – 2:15 pm Course Delivery

2:15 – 2:30 pm Q&A Session

Areas Covered in the Seminar:

• Glossary of Terms.

• Defining the Opportunity.

• Country Facts: Argentina, Brazil, Mexico.

• Latin America's Regulatory Structure for the Life Science Product Industries

• Mercosur - Southern Common Market.

• Beginning Your Company Involvement in Latin America: Examples of Country Requirements.

• Registration / Required Country Licenses.

• Common Fees.

• Overview of the Rules Governing Medicinal Products & Medical Devices.

o Select Examples of:Clinical Trials, GCP, GMP, Specials, Marketing Authorizations, Product Classifications, Scientific Advice, Generics Pricing, Patents, Labeling, SPC, Variations, Manufacturing Licenses, Renewals, Pharmacovigilance, Orphan Drugs.

• Marketing Authorization Processes - Filings & Registrations.

o Drug vs. Medical Device vs. Biologic vs. Combination Product.

• Drug Master File (DMF) Use in Latin America Registrations.

• Use of Expert Reports.

• Processing Variations on Licensed Products.

o Variations: Changes to Marketed Products.

o Types of Variations.

o Dossier Maintenance Expectations.

o Changes Concerning Manufacturing Aspects (Product & Process).

• Labeling & Packaging Leaflet Requirements.

• Orphan Drugs / Rare Diseases.

• Comparing and Contrasting Latin American Procedures vs. the U.S. FDA.

o Comparison of Processes.

o Agency Interactions.

o Accepted Practices.

• How and When to Influence the Regulatory Process.

o Accepted Country Practices.

o Effective Monitoring Activity.

o Association vs. Individual Company Involvement & Intervention.

• The Regulatory Negotiation Process.

o Effective Approaches.

o The Do's and Don'ts of Regulatory Involvement.

• How to Use Regulations / Regulatory Contacts to Your Advantage.

o Check-in Procedure.

o Agency Interactions.

o Business Impact Within and Outside Latin America.

o Professionalism in Regulatory Lobbying.

• Resources / Helpful Websites

Who Will Benefit:

This course will be beneficial to:

• Regulatory personnel whose responsibilities require knowledge of the Latin American regulatory environment

• Administrative staff responsible for ensuring compliance with regulatory filings and overall regulatory compliance requirements

• QA / QC Personnel

• Global Supply Chain personnel

• Clinical / Pharma & Device personnel

• Manufacturing personnel

• Global Business Development personnel

• Any sales or general management employee requiring an understanding of how regulations and compliance issues impact the organization

About Speaker

Robert J. Russell, is President and CEO of RJR Consulting, Inc, a leading Global Regulatory Consulting firm focusing on assisting the Life Science Industry. Prior to founding the firm in 2000, Mr. Russell had over 27 years of experience in CMC, Global Business Development and Regulatory Compliance for pharmaceuticals, biologist, medical devices and combination products. The company has an office in Brussels, Belgium where they interact with the European Commission and the Competent Authorities across the EU. Country establishment, marketing authorizations, variations and license renewals are core competencies of the course director. Mr. Russell has received a B.S. and M.S.in Chemistry.

Price List: Live: $189.00 One Dial In - Unlimited attendance $249 Recorded: $289.00, CD: $349.00
For any assistance contact us at support@compliance2go.com or call us at 877.782.4696
https://www.compliance2go.com/index.php?option=com_training&speakerkey=8...

Description

This course is designed for all levels of quality experience.

For the beginner, the course provides a logical and graphical perspective, enabling them to understand how the quality principles apply to their role and responsibilities. They will be able to apply these principles to their daily activities In preparation for advancement.

For the intermediate & advanced, they will be able to apply what they have learned to better manage quality, solve problems, improve internal auditing and make quality system improvements

This course brings the complex elements together into a congruent pattern that provides attendees insight to confidently apply these principles to their quality and regulatory environment. This course will explore the similarities and differences between these two guidance documents. First, the current environment that makes up the relationship between industry, regulatory bodies, health care givers, and the patient will be discussed. Next, quality principles will be examined and discussed followed by a review of the regulations based on these quality principles.

This new paradigm forces industry leaders and the FDA to rethink their roles in this dynamic regulatory-business environment. Management must partner with Quality in order to establish, implement, and meet corporate objectives.

It challenges the FDA to focus on the importance of employing practical quality principles that emphasize the importance of designing for user and customer requirements. Management must have a quality process that assures these requirements are translated into a viable process through technology transfer, process validation and a monitoring system that provides data for analysis and evaluation.

This course will explore the similarities and differences between these two guidance documents. First, the current environment that makes up the relationship between industry, regulatory bodies, health care givers, and the patient will be discussed. Next, quality principles will be examined and discussed followed by a review of the regulations based on these quality principles. Next, using a cross-index between the two documents, the key elements of these documents and their relationship will be studied.

Why should you attend :

This will provide considerable insight into how quality systems are constructed and operate to meet customer requirements. From these discussions, you will gain insight about how to actualize product and quality system improvements, as well to develop your own quality system.

Objectives & Overview

Good Manufacturing Practices And Quality Systems.

The Past, the Current, & the Future-The Changing

Defining Quality

Similarities between ICH Q 10 and Quality Systems Approach

Differences between ICH Q 10 and Quality Systems Approach

Quality Assurance and Production Responsibilities

Pharmaceutical Product Lifecycles.

Knowledge Management

Quality Improvement

Who will benefit:

Quality Control Laboratory Manager

Warehousing

Purchasing Managers and Procurement Managers

Laboratory Analyst

Cost Accounting

IT

Documentation Management

About Speaker

Howard T. Cooper enjoys sharing his 30 years plus experience in starting up, developing, implementing, managing, and remediating pharmaceutical and medical device quality systems. He has a BS in Biology/Chemistry and Political Science as well as work toward an MBA.

His ability to quickly learn the technology is demonstrated by his success in applying quality assurance principles to a wide range of pharmaceuticals and medical devices. He is a Certified Biomedical Auditor (CBA), Certified Quality Manager (CQM), and Quality Auditor (CQA). His technical education is further complemented by his Political Science degree helping him understand the regulatory process; his work toward an MBA provides business insight. He is a member of ASQ, PDA, AAMI, RAPS, and SQA. He strongly believes that Quality is very influential in shaping successful operations.

He knows how to use his leadership abilities to build organizational relationships that make systems operate effectively as well as to develop and empower people.

Price List: Live: $189.00 One Dial In - Unlimited attendance $249 Recorded: $289.00, CD: $349.00
For any assistance contact us at support@compliance2go.com or call us at 877.782.4696
https://www.compliance2go.com/index.php?option=com_training&speakerkey=8...

Document control can be a time- and paper-consuming process. Even the simplest of changes often requires an inordinate amount of time spent in the preparation, submission, distribution, and implementation of change requests, document modifications, document review meetings, document approvals, and document placement. Many companies can spend MUCH LESS time and prepare MANY LESS documents, and still be in compliance with the regulations. This presentation will review the QSR and ISO requirements for document control, and provide a streamlined process for document control. Records maintenance, distribution, and management can be similarly streamlined by this system.

Areas Covered in the Session

- QSR and ISO 13485 requirements for document control

- Description of typical document control system in use

- Streamlined document control process

- Paper-free document review

- Immediate document distribution

Who will benefit: (Titles)

The employees who will benefit include:

· Executive Management

· Document Control Management

· Document Control Clerks

· Consultants

· Quality system auditors

About Speaker

Jeff Kasoff, RAC, is the Director of Quality at Byrne Medical, a leading manufacturer of endoscopy products. In this position, Jeff is responsible for supplier management, during which he oversees supplier management, CAPA, and document control. Prior to this, Jeff spent 13 years at Life-Tech as the Director of Regulatory Affairs, where he was responsible for regulatory compliance of all aspects of the quality system. Jeff received his regulatory affairs certification in 1996.

Description

Document control can be a time- and paper-consuming process. Even the simplest of changes often requires an inordinate amount of time spent in the preparation, submission, distribution, and implementation of change requests, document modifications, document review meetings, document approvals, and document placement. Many companies can spend MUCH LESS time and prepare MANY LESS documents, and still be in compliance with the regulations. This presentation will review the QSR and ISO requirements for document control, and provide a streamlined process for document control. Records maintenance, distribution, and management can be similarly streamlined by this system.

Areas Covered in the Session

- QSR and ISO 13485 requirements for document control

- Description of typical document control system in use

- Streamlined document control process

- Paper-free document review

- Immediate document distribution

Who will benefit: (Titles)

The employees who will benefit include:

· Executive Management

· Document Control Management

· Document Control Clerks

· Consultants

· Quality system auditors

About Speaker

Jeff Kasoff, RAC, is the Director of Quality at Byrne Medical, a leading manufacturer of endoscopy products. In this position, Jeff is responsible for supplier management, during which he oversees supplier management, CAPA, and document control. Prior to this, Jeff spent 13 years at Life-Tech as the Director of Regulatory Affairs, where he was responsible for regulatory compliance of all aspects of the quality system. Jeff received his regulatory affairs certification in 1996.

Description

This course is designed for all levels of quality experience.

For the beginner, the course provides a logical and graphical perspective, enabling them to understand how the quality principles apply to their role and responsibilities. They will be able to apply these principles to their daily activities In preparation for advancement.

For the intermediate & advanced, they will be able to apply what they have learned to better manage quality, solve problems, improve internal auditing and make quality system improvements

This course brings the complex elements together into a congruent pattern that provides attendees insight to confidently apply these principles to their quality and regulatory environment. This course will explore the similarities and differences between these two guidance documents. First, the current environment that makes up the relationship between industry, regulatory bodies, health care givers, and the patient will be discussed. Next, quality principles will be examined and discussed followed by a review of the regulations based on these quality principles.

This new paradigm forces industry leaders and the FDA to rethink their roles in this dynamic regulatory-business environment. Management must partner with Quality in order to establish, implement, and meet corporate objectives.

It challenges the FDA to focus on the importance of employing practical quality principles that emphasize the importance of designing for user and customer requirements. Management must have a quality process that assures these requirements are translated into a viable process through technology transfer, process validation and a monitoring system that provides data for analysis and evaluation.

This course will explore the similarities and differences between these two guidance documents. First, the current environment that makes up the relationship between industry, regulatory bodies, health care givers, and the patient will be discussed. Next, quality principles will be examined and discussed followed by a review of the regulations based on these quality principles. Next, using a cross-index between the two documents, the key elements of these documents and their relationship will be studied.

Why should you attend :

This will provide considerable insight into how quality systems are constructed and operate to meet customer requirements. From these discussions, you will gain insight about how to actualize product and quality system improvements, as well to develop your own quality system.

Objectives & Overview

Good Manufacturing Practices And Quality Systems.

The Past, the Current, & the Future-The Changing

Defining Quality

Similarities between ICH Q 10 and Quality Systems Approach

Differences between ICH Q 10 and Quality Systems Approach

Quality Assurance and Production Responsibilities

Pharmaceutical Product Lifecycles.

Knowledge Management

Quality Improvement

Who will benefit:

Quality Control Laboratory Manager

Warehousing

Purchasing Managers and Procurement Managers

Laboratory Analyst

Cost Accounting

IT

Documentation Management

About Speaker

Howard T. Cooper enjoys sharing his 30 years plus experience in starting up, developing, implementing, managing, and remediating pharmaceutical and medical device quality systems. He has a BS in Biology/Chemistry and Political Science as well as work toward an MBA.

His ability to quickly learn the technology is demonstrated by his success in applying quality assurance principles to a wide range of pharmaceuticals and medical devices. He is a Certified Biomedical Auditor (CBA), Certified Quality Manager (CQM), and Quality Auditor (CQA). His technical education is further complemented by his Political Science degree helping him understand the regulatory process; his work toward an MBA provides business insight. He is a member of ASQ, PDA, AAMI, RAPS, and SQA. He strongly believes that Quality is very influential in shaping successful operations.

He knows how to use his leadership abilities to build organizational relationships that make systems operate effectively as well as to develop and empower people.