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Good Documentation Practices and Data Integrity

February 28

There is no doubt that data integrity is the current and future inspection focus of all regulatory health care agencies. More than 50% inspection reports such as 483’s, Warning Letters, and Health Canada observations quote data integrity as deviations from GxP regulations. With a number of recent regulatory guidance documents published on the subject, Health Canada and FDA are expecting Pharmaceutical Companies to demonstrate strong control on Data and close management of GDP. It is therefore essential that you have the correct understanding of what is required. This course covers the background to Data Integrity, how it linked to GDP, why it is important, and how its requirements affect both paper-based and computer-based systems. This course is based on FDA requirements and GUI-0001, Good Manufacturing Practices Guide for Drug Products, implemented on October 1, 2018.

Date: Thursday February 28, 2019 | Montreal, Canada (Séance Bilingue / Bilingual Session)

Date: Thursday March 14, 2019 | Toronto, Canada

Time: 9AM-5PM 

  • GDP and Data
  • Data Integrity – impact to product quality
  • Documentation: How, when, what and why document
  • GDP QUIZE
  • Data Integrity – Regulatory Expectations regarding:
    • Paper (manually completed) records
    • Computer systems
    • Laboratory & manufacturing records
  • ALCOA & ALCOA+
  • GUI-0001 Good manufacturing practices guide for drug products
  • FDA – Data Integrity and Compliance With CGMP Guidance for Industry
  • FDA Warning Letters
  • Bad Practices
  • Specific cases interactive discussions on different Data Integrity and GDP cases (Right or Wrong: What Do You Think?)

 

Natasha Demberg, President, Demberg PharmaSolutions

Natasha Demberg is a Pharmaceutical and Biotechnology Quality and BD Executive with 25+ years in the development and application of Quality Management Systems throughout the product life-cycle (development, scale-up, and commercialization) and Business Development for Pharmaceutical service providers. She created and managed Quality Organizations, which operate under different cGMP regulations such as: Pharmaceutical, Pharmaceutical Class IV (OTC), Medical Devices class IV – I, Natural Health, and Cosmetic Act as well as ISO 9001 and ISO 13485 regulations.

Mrs. Demberg is experienced in leading multi-functional groups to address challenging global regulatory compliance issues, develop strategy for Quality and Business Development, and create company culture oriented to Quality and Customer needs. Mrs. Demberg has audit expertise that spans cGMP compliance, mock-FDA and HC inspections, PAI readiness, and suppliers and vendors audits and qualification. As a BD executive Mrs. Demberg has an expertise of creating the client oriented company culture, efficient customer support and service, and Business Development and sales.

Currently, Mrs. Demberg is providing Quality & Compliance, consulting services for Pharmaceutical and Biotechnology firms. In addition to Quality & Compliance, Mrs. Demberg provides Business Development support to the service companies in Life Science industry.

She is known for her dynamic leadership style and her ability to think strategically. She brings with her the tremendous mix of both technical expertise and regulatory knowledge.

Natasha’s career has included a wide range of successful leadership positions in Quality Organizations of several large companies in the pharmaceutical field. Initially as a chemist at Plantex Teva and Abbott Laboratory and later as Senior GMP Compliance Associate at Merck Frosst Canada, responsible for Quality aspect of Clinical manufacturing, Head of Quality at Valeant Canada and Confab Laboratory responsible of entire Quality Operations, and Vice President Pharmaceutical Solution at Neopharm Labs.

Mrs. Demberg holds a BSc in Chemical Engineering and a MSc in Chemistry of Polymers and is a member of the Quebec Chapter of the Society of Chemists, L’Ordre des chimistes du Québec.

Target Industry: Pharma, Natural Health Products, Medical Devices

Who Should Attend:

  • QA managers and personnel
  • Laboratory managers and supervisors
  • Production managers and supervisors
  • Analysts
  • Training departments
  • Documentation departments Companies and departments:
  • Pharmaceutical development and Quality control laboratories
    • Quality control laboratories of API manufacturers
    • Medical device companies
    • Contract laboratories

Registration Fee & Discounts for Thursday February 28, 2019 | Montreal, Canada

Early Bird: Till January 28, 2019

Regular Price: January 29, 2019 to February 28, 2019

$528 CAD + HST $628 CAD + HST

Registration Fee & Discounts for Thursday March 14, 2019 | Toronto, Canada

Early Bird: Till February 14, 2019

Regular Price: February 15, 2019 to March 14, 2019

$528 CAD + HST $628 CAD + HST

Academia / Government

At all time 

$388 CAD + HST

The fee is payable in advance and includes continental breakfast, lunch & refreshments, course material and certificate of attendance.


Group Registration Discount
Group Registration is available for all our live events. Please contact us: By email: enquiry@ipacanada.com or Call: 416-410-7402

Cancellation Policy
Cancellations received in writing more than 3 weeks before the event will be subject to a service charge of $150.00 CAD. The full conference fees remain payable if cancellations are received less than 3 weeks prior to the event. Substitutions are welcome at any time. It may be necessary for reasons beyond the control of the organizer to alter the timing of the program or the identity of the speakers. In the unfortunate event that an event is cancelled IPA are not liable for any costs incurred by delegates in connection with their attendance.

Course Venue & Hotel Accommodation

Hôtel DoubleTree by Hilton Aéroport de Montréal

705, Avenue Michel-Jasmin, Dorval (QC) H9P 1B8 | Tel: 1-514-631-4811 | Website

IPA is arranging a special room rate for attendees at the DoubleTree (Conference Venue). Stay Tuned for a special group rate and group code!. Note Guests are responsible for their own accommodations.

 

 

 

Details

Date:
February 28
Event Category:
Event Tags:
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Venue

Montreal, Canada
Canada + Google Map