DATA INTEGRITY FINDINGS,
483 & WARNING LETTERS -
WHAT IS THE FDA LOOKING FOR?

On December 2018, the FDA published the Final Guide for Data Integrity in the regulated industry. But even before that, the FDA has been pounding the industry with findings related to Data Integrity. All FDA-regulated companies are currently working on Data Integrity and everybody is talking about the topic. Are we really focusing on the facts we should be focusing? Which observations the FDA has been finding on the audits?

This webinar is set to present and discuss between 12-15 different observations from the FDA to different companies. The idea is to raise the level of awareness so you can help your sites to be in compliance.

Part I – Concepts around Data Integrity Guideline

What’s ALCOA and what’s ALCOA+
Is Data Integrity something really new in the industry

Part 2 – Findings, Observations, FD-483, Warning Letters

Discussions of different Data Integrity Findings
Why are those findings related to Data Integrity

Learning Goals

Understanding FDA expectations related to Data Integrity
To have a flavor of the type of observations that the FDA has been finding during the audits

Top Reasons to Attend:

You will be able to identify the requirements presented in the new FDA Guideline on Data Integrity and how they related to the findings.
The attendees should leave with a better understanding of the FDA expectations on the guideline.
You will be able to understand how the human factor might affect Data Integrity
Attendees will receive information related to FDA Findings on Data Integrity that will be able to use to prevent situations on their respective companies.
The people in the conference will be able to understand the basics findings that should be avoided in order to develop a robust Data Integrity Program
The attendees will be able to take in consideration the human factor when developing their Data Integrity Programs.
To identify some tools for Data and Report Management.
To understand the role of the Senior Management in Data Integrity
To understand the role of each one of us in our sites concerning Data Integrity
To learn how to deal with Data Integrity findings

SPEAKERS

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Chinmoy Roy

Senior Industry Consultant, VALGENESIS

Chinmoy Roy is an experienced biopharmaceutical consultant with subject matter expertise in CSV, Data Integrity, CFR 21 Part 11, Annex 11 and manufacturing process automation systems. He is a member of ISPE’s Data Integrity Special Interest Group (S.I.G). His presentations blend his field experience to highlight the intricacies of implementing regulations. Chinmoy has a bachelor’s degree in Electrical Engineer and a Master’s degree in Computer Science. [/av_textblock] [/av_three_fourth][/av_section]

August 11, 2020/by Chiara Travisano

Webinar

Ensuring Data Integrity for GxP Spreadsheets – Issues and Solutions

Ensuring Data Integrity for
GxP Spreadsheets –
Issues and Solutions

Spreadsheets are often a weak link in the data integrity compliance chain. If left uncontrolled, they present a major data integrity risk to the organization.

In the first part of this webinar, we will review the reasons for their popularity as well as interesting anecdotes about spreadsheet errors. We will understand common issues and problems, by analyzing warning letters related to spreadsheets, and go into much detail on what Part 11 compliance means when applied to spreadsheets.

In the 2nd part of the webinar, we will evaluate a number of alternatives for achieving Part 11 compliance and reducing data integrity risk. We will review a Spreadsheet Maturity Model that can be used to assess your organization’s level of maturity in spreadsheet controls.

Top Reasons to Attend

Common issues regarding the use of spreadsheets in a GxP requirement.
An analysis of a few Warning Letters specifically relating to spreadsheets.
Interesting statistics on spreadsheet errors
A detailed review of 21 CFR Part 11 requirements as it applies to spreadsheets
Learn where your organization fits in CIMINFO’s Spreadsheet Maturity Model.
Assess the suitability of native Windows / Excel functionality to address some of the gaps, as well as the limitations of these methods.
A review of automated tools for compliance and validation.

SPEAKERS

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President and CEO, CIMINFO Software

Sanjay Agrawal is President and CEO of CIMINFO Software. He has over 25 years of experience in Computer Systems Validation and Data Integrity Compliance. He has managed validation projects for a wide range of systems including PLCs, manufacturing/lab equipment, and various levels of software. He pioneered risk based validation methodologies for large scale enterprise software such as ERP and MES systems, and has developed Facility-wide Master Validations Plans for new facilities. Sanjay founded the company CIMCON Software (which has now been renamed to CIMINFO) 20+ years ago to automate the management and control of spreadsheets, legacy lab software, document management, and other key GxP processes. [/av_textblock] [/av_three_fourth][/av_section]

August 11, 2020/by Chiara Travisano

Webinar

SALES REPRESENTATIVES ON THE BRINK OF EXTINCTION? THE FUTURE OF MSLS & MEDICAL

SALES REPRESENTATIVES ON THE BRINK OF EXTINCTION?
THE FUTURE OF MSLS & MEDICAL

In recent years, the Medical function within pharmaceutical and biotech companies has grown exponentially—some say to the point of eliminating the need for sales representatives. Many health care professionals view MSLs and other Medical personnel as trusted resources, who are able to provide information not only about the company’s product, but also about current research and trends in the treatment of patients with a particular disease. Key opinion leaders look to MSLs to help them wade through the morass of published data and to provide insights on health outcomes and the real-world effectiveness of drugs that they can use in the exam room. As personalized medicine becomes the norm, the need for medical education from highly trained scientific professionals on the use of these complicated products will only grow.

In response, companies are increasingly allowing their MSLs to engage in proactive communications with health care professionals. Some have expanded the scope and content of information they make available on medical information websites. This session will explore the changing role of Medical in the commercialization of pharmaceutical and biotech products. We will discuss the interplay between Medical and Commercial and consider ways to empower Medical teams to provide information to stakeholders in a compliant manner. In addition, we will consider how companies can assess the value of MSLs and how they can leverage the insights MSLs bring back from their discussions with clinicians and academics.

Top 10 Reasons To Attend:

Learn about trends in proactive outreach by MSLs.
Discuss whether and when off-label information can be provided to key opinion leaders.
Hear the government’s view of MSL interactions with health care professionals.
Understand the role of the MSL pre-launch.
Gain insight on appropriate interactions between Medical and Commercial.
Consider the guardrails for MSL communications with non-physician stakeholders, such as payers and patients.
Explore whether companies should allow standing Medical requests.
Get advice on how to avoid MSLs being perceived as “smarter sales reps.”
Address whether and how MSLs should remain unbiased.
Learn how to ease concerns within Medical about the “new normal.”

SPEAKERS

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Stefanie A. Doebler

OF COUNSEL, COVINGTON & BURLING LLP

Stefanie Doebler is co-chair of the firm's Health Care Practice Group, and a member of the Food, Drug, and Device Practice Group. Her practice focuses on health care compliance matters for pharmaceutical, biotech, and medical device clients. She provides advice related to advertising and promotion, fraud and abuse, transparency requirements, state law compliance and reporting regulations, interactions with health care professionals, Medicaid price reporting, and other aspects of federal and state regulation of pharmaceuticals, biologics, and medical devices. Ms. Doebler also advises on the development and implementation of health care compliance programs.

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July 29, 2020/by rculver

Webinar

COMPLIANCE IN THE TIME OF COVID: EVALUATING PROMOTIONAL ACTIVITIES

COMPLIANCE IN THE TIME OF COVID:
EVALUATING PROMOTIONAL ACTIVITIES

The COVID-19 pandemic has resulted in pharmaceutical and medical device manufacturers having to devise alternative, often remote or virtual methods to interact with health care providers and patients. Some of these activities had already raised heightened scrutiny from enforcement authorities before the pandemic. But the necessity of the situation continues to drive these interactions in increasing numbers, without tried and true compliance techniques to address potential risks.

This webinar will identify and analyze some of these key trending compliance challenges facing life sciences entities, including:

Arrangements with Electronic Health Records Providers (including an examination of the recent Practice Fusion settlement);
Arrangements with telemedicine organizations and structures;
HUB services and call center arrangements; and
Arrangements with patient organizations and medical societies.

The program will examine both traditional compliance risks as well as novel challenges and risks that accompany changes in business operations arising amidst the coronavirus pandemic. The speakers will focus on helping to identify the specific risk issues that are most likely to arise, including how some of these risks may already be a focus of investigations and enforcement efforts. In addition, this session will provide recommendations and suggestions on compliance measures that companies might employ to address these novel risks.

Attendees Will Gain Awareness Of The Following:

- New and evolving methods to interact with health care providers and patients
- Novel compliance risks associated with these new and evolving methods
- Ongoing investigations and enforcement actions
- The sometimes conflicting messages of government policy statements and enforcement activities
- Proactive steps to get out in front of compliance and create protections as your company enters into these new areas

Top Reasons To Attend:

- - Understand and appreciate the new ways in which companies are expanding interactions with health care providers and patients
  - Learn how to identify the key risks associated with new and changing activities
  - Understand benchmarking data about what companies are likely to continue doing in a post-pandemic environment
  - Get a picture of what types of enforcement are already ongoing, and what is likely to be forthcoming
  - Develop insights into how to address potential risks for your company
  - You will be able to understand how best navigate the changing environment from both a business and compliance perspective

SPEAKERS

[av_section min_height='' min_height_px='500px' padding='default' shadow='no-border-styling' bottom_border='no-border-styling' bottom_border_diagonal_color='#333333' bottom_border_diagonal_direction='' bottom_border_style='' custom_margin='0px' custom_margin_sync='true' custom_arrow_bg='' id='' color='main_color' background='bg_color' custom_bg='#ececec' background_gradient_color1='' background_gradient_color2='' background_gradient_direction='vertical' src='' attachment='' attachment_size='' attach='scroll' position='top left' repeat='no-repeat' video='' video_ratio='16:9' overlay_opacity='0.5' overlay_color='' overlay_pattern='' overlay_custom_pattern='' av_element_hidden_in_editor='0' av_uid='av-17kvae' custom_class=''] [av_one_fourth first min_height='' vertical_alignment='' space='' custom_margin='' margin='0px' row_boxshadow='' row_boxshadow_color='' row_boxshadow_width='10' link='' linktarget='' link_hover='' padding='0px' highlight='' highlight_size='' border='' border_color='' radius='0px' column_boxshadow='' column_boxshadow_color='' column_boxshadow_width='10' background='bg_color' background_color='' background_gradient_color1='' background_gradient_color2='' background_gradient_direction='vertical' src='' background_position='top left' background_repeat='no-repeat' animation='' mobile_breaking='' mobile_display='' av_uid='av-10fcge'] [av_image src='https://kenx.org/wp-content/uploads/2020/07/Seth-Lundy-300x199.jpg' attachment='24272' attachment_size='medium' align='center' styling='' hover='' link='' target='' caption='' font_size='' appearance='' overlay_opacity='0.4' overlay_color='#000000' overlay_text_color='#ffffff' copyright='' animation='no-animation' av_uid='av-x3ejy' custom_class='' admin_preview_bg=''][/av_image] [/av_one_fourth][av_three_fourth min_height='' vertical_alignment='' space='' custom_margin='' margin='0px' row_boxshadow='' row_boxshadow_color='' row_boxshadow_width='10' link='' linktarget='' link_hover='' padding='0px' highlight='' highlight_size='' border='' border_color='' radius='0px' column_boxshadow='' column_boxshadow_color='' column_boxshadow_width='10' background='bg_color' background_color='' background_gradient_color1='' background_gradient_color2='' background_gradient_direction='vertical' src='' background_position='top left' background_repeat='no-repeat' animation='' mobile_breaking='' mobile_display='' av_uid='av-t3ewu'] [av_textblock size='18' font_color='' color='' av-medium-font-size='' av-small-font-size='' av-mini-font-size='' av_uid='av-j0keu' custom_class='' admin_preview_bg='']

Seth H. Lundy

PARTNER, KING & SPALDING

Seth Lundy represents prominent medical device and pharmaceutical companies and healthcare providers, suppliers and distributors in complex legal and regulatory matters and investigations. As Deputy Chair of our FDA and Life Sciences practice, identified by Law360 as Life Sciences Group of the Year for 2016, Seth is widely recognized as a leading national authority on compliance with federal and state fraud and abuse laws. His practical, business-oriented approach earns accolades from sources including Chambers USA, Best Lawyers and Super Lawyers. [/av_textblock] [/av_three_fourth][/av_section] [av_section min_height='' min_height_px='500px' padding='default' shadow='no-border-styling' bottom_border='no-border-styling' bottom_border_diagonal_color='#333333' bottom_border_diagonal_direction='' bottom_border_style='' custom_margin='0px' custom_margin_sync='true' custom_arrow_bg='' id='' color='main_color' background='bg_color' custom_bg='#ececec' background_gradient_color1='' background_gradient_color2='' background_gradient_direction='vertical' src='' attachment='' attachment_size='' attach='scroll' position='top left' repeat='no-repeat' video='' video_ratio='16:9' overlay_opacity='0.5' overlay_color='' overlay_pattern='' overlay_custom_pattern='' av_element_hidden_in_editor='0' av_uid='av-17kvae' custom_class=''] [av_one_fourth first min_height='' vertical_alignment='' space='' custom_margin='' margin='0px' row_boxshadow='' row_boxshadow_color='' row_boxshadow_width='10' link='' linktarget='' link_hover='' padding='0px' highlight='' highlight_size='' border='' border_color='' radius='0px' column_boxshadow='' column_boxshadow_color='' column_boxshadow_width='10' background='bg_color' background_color='' background_gradient_color1='' background_gradient_color2='' background_gradient_direction='vertical' src='' background_position='top left' background_repeat='no-repeat' animation='' mobile_breaking='' mobile_display='' av_uid='av-10fcge'] [av_image src='https://kenx.org/wp-content/uploads/2020/07/Gina-Cavalier-300x200.png' attachment='24274' attachment_size='medium' align='center' styling='' hover='' link='' target='' caption='' font_size='' appearance='' overlay_opacity='0.4' overlay_color='#000000' overlay_text_color='#ffffff' copyright='' animation='no-animation' av_uid='av-x3ejy' custom_class='' admin_preview_bg=''][/av_image] [/av_one_fourth][av_three_fourth min_height='' vertical_alignment='' space='' custom_margin='' margin='0px' row_boxshadow='' row_boxshadow_color='' row_boxshadow_width='10' link='' linktarget='' link_hover='' padding='0px' highlight='' highlight_size='' border='' border_color='' radius='0px' column_boxshadow='' column_boxshadow_color='' column_boxshadow_width='10' background='bg_color' background_color='' background_gradient_color1='' background_gradient_color2='' background_gradient_direction='vertical' src='' background_position='top left' background_repeat='no-repeat' animation='' mobile_breaking='' mobile_display='' av_uid='av-t3ewu'] [av_textblock size='18' font_color='' color='' av-medium-font-size='' av-small-font-size='' av-mini-font-size='' av_uid='av-j0keu' custom_class='' admin_preview_bg='']

Gina M. Cavalier

PARTNER, KING & SPALDING

Gina Cavalier is healthcare fraud and abuse and compliance lawyer, who focuses her practice on the life sciences industry. A partner in our FDA and Healthcare practices, she advises a wide range of life sciences and healthcare clients, specializing in complex fraud and abuse issues arising under the Anti-Kickback Statute, as well as other federal and state anti-fraud authorities. Gina's solution-focused advice and seasoned perspective earns accolades from sources including Chambers USA, Daily Journal and LMG Life Sciences. [/av_textblock] [/av_three_fourth][/av_section] [av_section min_height='' min_height_px='500px' padding='default' shadow='no-border-styling' bottom_border='no-border-styling' bottom_border_diagonal_color='#333333' bottom_border_diagonal_direction='' bottom_border_style='' custom_margin='0px' custom_margin_sync='true' custom_arrow_bg='' id='' color='main_color' background='bg_color' custom_bg='#ececec' background_gradient_color1='' background_gradient_color2='' background_gradient_direction='vertical' src='' attachment='' attachment_size='' attach='scroll' position='top left' repeat='no-repeat' video='' video_ratio='16:9' overlay_opacity='0.5' overlay_color='' overlay_pattern='' overlay_custom_pattern='' av_element_hidden_in_editor='0' av_uid='av-17kvae' custom_class=''] [av_one_fourth first min_height='' vertical_alignment='' space='' custom_margin='' margin='0px' row_boxshadow='' row_boxshadow_color='' row_boxshadow_width='10' link='' linktarget='' link_hover='' padding='0px' highlight='' highlight_size='' border='' border_color='' radius='0px' column_boxshadow='' column_boxshadow_color='' column_boxshadow_width='10' background='bg_color' background_color='' background_gradient_color1='' background_gradient_color2='' background_gradient_direction='vertical' src='' background_position='top left' background_repeat='no-repeat' animation='' mobile_breaking='' mobile_display='' av_uid='av-10fcge'] [av_image src='https://kenx.org/wp-content/uploads/2020/07/Brian-Bohenkamp-300x199.jpg' attachment='24273' attachment_size='medium' align='center' styling='' hover='' link='' target='' caption='' font_size='' appearance='' overlay_opacity='0.4' overlay_color='#000000' overlay_text_color='#ffffff' copyright='' animation='no-animation' av_uid='av-x3ejy' custom_class='' admin_preview_bg=''][/av_image] [/av_one_fourth][av_three_fourth min_height='' vertical_alignment='' space='' custom_margin='' margin='0px' row_boxshadow='' row_boxshadow_color='' row_boxshadow_width='10' link='' linktarget='' link_hover='' padding='0px' highlight='' highlight_size='' border='' border_color='' radius='0px' column_boxshadow='' column_boxshadow_color='' column_boxshadow_width='10' background='bg_color' background_color='' background_gradient_color1='' background_gradient_color2='' background_gradient_direction='vertical' src='' background_position='top left' background_repeat='no-repeat' animation='' mobile_breaking='' mobile_display='' av_uid='av-t3ewu'] [av_textblock size='18' font_color='' color='' av-medium-font-size='' av-small-font-size='' av-mini-font-size='' av_uid='av-j0keu' custom_class='' admin_preview_bg='']

Brian A. Bohnenkamp

PARTNER, KING & SPALDING

Brian Bohnenkamp specializes in regulatory and compliance matters relating to drug, biotechnology and medical device companies. A partner in our FDA practice and a member of our Life Sciences group, Brian has extensive experience counseling manufacturers on fraud and abuse laws, industry codes of conduct, federal and state transparency laws and regulations, state and local gift bans, compliance program laws and sales representative licensing requirements, as well as government ethics restrictions. [/av_textblock] [/av_three_fourth][/av_section] [av_section min_height='' min_height_px='500px' padding='default' shadow='no-border-styling' bottom_border='no-border-styling' bottom_border_diagonal_color='#333333' bottom_border_diagonal_direction='' bottom_border_style='' custom_margin='0px' custom_margin_sync='true' custom_arrow_bg='' id='' color='main_color' background='bg_color' custom_bg='#ececec' background_gradient_color1='' background_gradient_color2='' background_gradient_direction='vertical' src='' attachment='' attachment_size='' attach='scroll' position='top left' repeat='no-repeat' video='' video_ratio='16:9' overlay_opacity='0.5' overlay_color='' overlay_pattern='' overlay_custom_pattern='' av_element_hidden_in_editor='0' av_uid='av-17kvae' custom_class=''] [av_one_fourth first min_height='' vertical_alignment='' space='' custom_margin='' margin='0px' row_boxshadow='' row_boxshadow_color='' row_boxshadow_width='10' link='' linktarget='' link_hover='' padding='0px' highlight='' highlight_size='' border='' border_color='' radius='0px' column_boxshadow='' column_boxshadow_color='' column_boxshadow_width='10' background='bg_color' background_color='' background_gradient_color1='' background_gradient_color2='' background_gradient_direction='vertical' src='' background_position='top left' background_repeat='no-repeat' animation='' mobile_breaking='' mobile_display='' av_uid='av-10fcge'] [av_image src='https://kenx.org/wp-content/uploads/2020/07/Terrence-Burek-300x199.jpg' attachment='24271' attachment_size='medium' align='center' styling='' hover='' link='' target='' caption='' font_size='' appearance='' overlay_opacity='0.4' overlay_color='#000000' overlay_text_color='#ffffff' copyright='' animation='no-animation' av_uid='av-x3ejy' custom_class='' admin_preview_bg=''][/av_image] [/av_one_fourth][av_three_fourth min_height='' vertical_alignment='' space='' custom_margin='' margin='0px' row_boxshadow='' row_boxshadow_color='' row_boxshadow_width='10' link='' linktarget='' link_hover='' padding='0px' highlight='' highlight_size='' border='' border_color='' radius='0px' column_boxshadow='' column_boxshadow_color='' column_boxshadow_width='10' background='bg_color' background_color='' background_gradient_color1='' background_gradient_color2='' background_gradient_direction='vertical' src='' background_position='top left' background_repeat='no-repeat' animation='' mobile_breaking='' mobile_display='' av_uid='av-t3ewu'] [av_textblock size='18' font_color='' color='' av-medium-font-size='' av-small-font-size='' av-mini-font-size='' av_uid='av-j0keu' custom_class='' admin_preview_bg='']

Terrence B. Burek

SENIOR ASSOCIATE, KING & SPALDING

Terrence Burek is a senior associate in King & Spalding’s Washington, D.C., office and is a member of the FDA and Life Sciences practice. Terrence focuses his practice on the regulation of medical device and pharmaceutical manufacturers, as well as healthcare providers and suppliers. His expertise is concentrated on healthcare fraud and abuse and compliance with federal and state laws (including the Anti-Kickback Statute) governing remunerative relationships between manufacturers and health care professionals. Terrence also provides counsel to both the Ad Hoc State Law Compliance Group on a variety of laws and regulations, including the federal Physician Payment Sunshine provisions, and the International Marketing and Disclosure Compliance Group on a variety of international laws, regulations and industry codes. [/av_textblock] [/av_three_fourth][/av_section]

July 24, 2020/by rculver

Webinar

CRITICAL STEPS IN CONTROLLING MICROBIAL CONTAMINATION

CRITICAL STEPS IN CONTROLLING
MICROBIAL CONTAMINATION

With patients’ lives on the line, mitigating microbial risk contamination is imperative to pharmaceutical product quality and safety. The ultimate cost of inadequate microbial control within pharmaceutical facilities is tremendous as production may have to be shut down for lengthy periods of time in order to conduct investigations and identify the root cause to prevent reoccurrence, loss of potential profit or consumer death.

From an appropriate facility design to developing a microbial control strategy, there are critical, proactive steps to follow in order to optimize control and reduce end-user risk. This webinar delves into the essential elements to comprehensive microbial control, offering implementable guidance and tactics to maintain GxP compliance.

Attendees Will Gain Awareness Of:

Appropriate facility design
Proper flow of personnel, material, and waste
Proper cleanroom behavior
Equipment design
Utility design
Microbial control strategy

Attendees Will Take With Them:

Step-by-step process for designing and implementing a microbial control strategy
Real-life examples from case studies
Industry best practices for design, maintenance, and cleanroom behavior

SPEAKERS

[av_section min_height='' min_height_px='500px' padding='default' shadow='no-border-styling' bottom_border='no-border-styling' bottom_border_diagonal_color='#333333' bottom_border_diagonal_direction='' bottom_border_style='' custom_margin='0px' custom_margin_sync='true' custom_arrow_bg='' id='' color='main_color' background='bg_color' custom_bg='#ececec' background_gradient_color1='' background_gradient_color2='' background_gradient_direction='vertical' src='' attachment='' attachment_size='' attach='scroll' position='top left' repeat='no-repeat' video='' video_ratio='16:9' overlay_opacity='0.5' overlay_color='' overlay_pattern='' overlay_custom_pattern='' av_element_hidden_in_editor='0' av_uid='av-17kvae' custom_class=''] [av_one_fourth first min_height='' vertical_alignment='' space='' custom_margin='' margin='0px' row_boxshadow='' row_boxshadow_color='' row_boxshadow_width='10' link='' linktarget='' link_hover='' padding='0px' highlight='' highlight_size='' border='' border_color='' radius='0px' column_boxshadow='' column_boxshadow_color='' column_boxshadow_width='10' background='bg_color' background_color='' background_gradient_color1='' background_gradient_color2='' background_gradient_direction='vertical' src='' background_position='top left' background_repeat='no-repeat' animation='' mobile_breaking='' mobile_display='' av_uid='av-10fcge'] [av_image src='https://kenx.org/wp-content/uploads/2020/07/MarieFranceQuillen-300x259.jpg' attachment='24263' attachment_size='medium' align='center' styling='' hover='' link='' target='' caption='' font_size='' appearance='' overlay_opacity='0.4' overlay_color='#000000' overlay_text_color='#ffffff' copyright='' animation='no-animation' av_uid='av-x3ejy' custom_class='' admin_preview_bg=''][/av_image] [/av_one_fourth][av_three_fourth min_height='' vertical_alignment='' space='' custom_margin='' margin='0px' row_boxshadow='' row_boxshadow_color='' row_boxshadow_width='10' link='' linktarget='' link_hover='' padding='0px' highlight='' highlight_size='' border='' border_color='' radius='0px' column_boxshadow='' column_boxshadow_color='' column_boxshadow_width='10' background='bg_color' background_color='' background_gradient_color1='' background_gradient_color2='' background_gradient_direction='vertical' src='' background_position='top left' background_repeat='no-repeat' animation='' mobile_breaking='' mobile_display='' av_uid='av-t3ewu'] [av_textblock size='18' font_color='' color='' av-medium-font-size='' av-small-font-size='' av-mini-font-size='' av_uid='av-j0keu' custom_class='' admin_preview_bg='']

Marie France Quillen

SENIOR DIRECTOR, AZZUR LABS

Marie France Quillen is the Senior Director of Azzur Labs Raleigh. She has more than 15 years of microbiology laboratory management and business development experience with leading life science manufacturers, including Pfizer and Novo Nordisk. During this time, she specialized in assessing systems for sustainability and assuring product quality by evaluating raw materials, supplies, and finished packaged products, and ensuring compliance with current Good Manufacturing Practices (cGMP). Additionally, Marie France managed the design and layout of new and redesigned laboratories, as well as method transfer for manufactured products. She is considered a subject matter expert in QC micro/biochemistry, total organic carbon (TOC), microbial identification, equipment and processes, and endotoxin testing. [/av_textblock] [/av_three_fourth] [/av_section]

July 24, 2020/by rculver

Archive for category: Webinar

DATA INTEGRITY FINDINGS, 483 & WARNING LETTERS - WHAT IS THE FDA LOOKING FOR?

SPEAKERS

Chinmoy Roy

Ensuring Data Integrity for GxP Spreadsheets – Issues and Solutions

Top Reasons to Attend

SPEAKERS

President and CEO, CIMINFO Software

SALES REPRESENTATIVES ON THE BRINK OF EXTINCTION? THE FUTURE OF MSLS & MEDICAL

SPEAKERS

Stefanie A. Doebler

COMPLIANCE IN THE TIME OF COVID: EVALUATING PROMOTIONAL ACTIVITIES

SPEAKERS

Seth H. Lundy

Gina M. Cavalier

Brian A. Bohnenkamp

Terrence B. Burek

CRITICAL STEPS IN CONTROLLING MICROBIAL CONTAMINATION

SPEAKERS

Marie France Quillen

DATA INTEGRITY FINDINGS,
483 & WARNING LETTERS -
WHAT IS THE FDA LOOKING FOR?

Ensuring Data Integrity for
GxP Spreadsheets –
Issues and Solutions

SALES REPRESENTATIVES ON THE BRINK OF EXTINCTION?
THE FUTURE OF MSLS & MEDICAL

COMPLIANCE IN THE TIME OF COVID:
EVALUATING PROMOTIONAL ACTIVITIES

CRITICAL STEPS IN CONTROLLING
MICROBIAL CONTAMINATION