This course will provide an overview of some relevant rules and regulations concerning their scientific basis, development and interpretation. It will prepare the attendees in implementing such regulations, and associated guidance documents, in a scientific and logical manner.
Appendix: Rules and regulations pertaining to quality of pharmaceutical products
Seminar Instructor Dr. Qureshi has extensive (30+ years) working experience, as a research scientist, with a regulatory agency (Health Canada). He is an internationally known expert on the subject and maintains a full command in the areas of drug dissolution testing, pharmacokinetics, biopharmaceutics and analytical chemistry as related to animal and human studies for developing and evaluating pharmaceutical products.
Areas Covered:
- Pharmaceutical Science
- Pharmaceutics
- Product Development
- Analytical Chemistry
- Method Development/Validation
- Regulatory and Pharmacopeial Requirements
- Manufacturing and Quality System Including cGMP & GLP
- Compliance and ISO requirements
- Quality Management System
Who will Benefit:
Anyone working as bench chemist/analyst, supervisor, manager, director or vice president in pharmaceutical manufacturing facilities, including laboratories and associated contract organizations, of innovator and generic companies for human and animal products, active and inactive (excipients) ingredient suppliers, contract research & development organizations, consultants and consulting organizations, suppliers of testing equipment in particular drug dissolution apparatuses in the following areas:
- Pharmaceutical Development
- Analytical methods (pharmacopeial, regulatory or in-house developed)
- R & D Departments (both analytical and formulation)
- Project Managers
- Scientists/Analysts
- Project Management
- Quality Control
- Quality Assurance
- Regulatory Affairs
Topic Background:
Pharmaceutical product developments, manufacturing and assessments are heavily regulated by concerned national and international authorities. To attain marketing authorizations usually in each and every country or region manufacturers are required to meet specific regulations and standards which are further supported by various guidance documents. There exist huge and seemingly endless varieties of such regulations and standards, which make it extremely difficult to comprehend and apply these in an objective manner. Although all these regulations and standards are supposed to be based on scientific foundation, however, science aspect seemingly has been absent, in fact, in many case, it has been violated. By taking a “back to the basics” approach, this course will first describe the required fundamental scientific principles followed by description of most commonly required regulations and standards in a systematic way using US FDA’s regulations and standards as the base.
- 08.30 AM - 09.00 AM: Registration
- 09.00 AM: Session Start
- Introduction: Interaction with attendees (1 Hour)
- Expertise and experiences of attendees - their expectations from the course/training
- My academic background, expertise and experiences working with the regulatory agency (Health Canada)
- Philosophy of my teaching
- Why am I teaching this course?
- What will you gain from this course? - Uniqueness!
- Science, science and science! (4 -5 Hours)
- Why science and what kind of science is needed to understand such a training?
- Who will use your science (supervisors, management, regulators and eventually consumer/patients)?
- Fundamental principles and requirements of underlying science: An overview
- Chemistry and analytical chemistry
- Drugs/pharmaceuticals/medicines vs drug/pharmaceutical/medicinal products
- Cosmetics, devices
- Pharmacology, pharmaceutics, pharmacokinetics
- Statistics, modelling
- Manufacturing (1 Hour)
- Manufacturing and its processes
- cGMPs - current practices and issues, how to address these - input/output model.
- Quality - defining it, measuring it and documenting it.
- Compliance vs Quality
- The Laws: Why and what (1/2 Hour)
- Regulatory specifics: (4-5 Hours)
- Regulations and guidance – US FDA
- Good laboratory practice (21CFR Part 58)
- Current good manufacturing practice (21CFR Parts 210/211)
- Quality system regulation (21CFR Part 820)
- Regulation and guidelines – Canadian & International
- Corresponding Canadian Statutory Orders and Regulations (SOR/98-282);
- Corresponding European Regulations (e.g. 93/42/EEC, 2007/47/EC)
- Others (Depending availability of time e.g. ANVISA)
- Regulation and guidelines – Putting it all together
- International Organization for Standardization (e.g. ISO13485:2016)
- ISO requirements vs GMP requirements.
- Record keeping, validation and audits (21CFR Part 11)
- Setting your “own” rules and standards!
- Regulations and guidance – US FDA
- Q & A, Discussion and Conclusions (1 Hour plus)
Saeed Qureshi
Principal, PharmacoMechanics (Former Senior Research Scientist at Health Canada)
Dr. Saeed Qureshi has extensive (30+ years) working experience, as a research scientist, with a regulatory agency (Health Canada). He is an internationally known expert on the subject and maintains a full command in the areas of drug dissolution testing, pharmacokinetics, biopharmaceutics and analytical chemistry as related to animal and human studies for developing and evaluating pharmaceutical products. His areas of expertise include: (1) Quality assessment of pharmaceutical products based on pharmacokinetic studies (e.g. bioavailability/bioequivalence) in humans and animals, including validation of in vitro results with in vivo (bioavailability) studies. (2) In vitro drug release characterization of pharmaceutical products in particular oral and dermal using dissolution and/or diffusion (absorption/penetration through skin) techniques. (3) Analytical methods development/validation for drug disposition evaluation in humans and animals using chromatographic (e.g. HPLC, GC, TLC) and spectroscopic (e.g. UV, MS) techniques. (4) Data analysis using sophisticated (SAS) and general-purpose (e.g. MS Excel) software.
Dr. Qureshi has extensively published in peer-reviewed journals and given numerous national and international presentations on the subject. Dr. Qureshi is very well known for his innovative but simple and practical ideas. Since 2010, he has been contributing and moderating a weblog (www.drug-dissolution-testing.com) which has become a popular source of new and thought provoking ideas for addressing the issues of product evaluations.
Since 2015 Dr. Qureshi has been working as an independent consultant. A detailed description of his expertise and the services he provides may be obtained from the website (www.pharmacomechanics.com).
Register Now
Online using Credit card
Get the Invitation
Pre-Register yourself and get the official Invite when venue and dates are announced for this seminar.
Call here to register +1-888-717-2436 or email at [email protected]
Other Registration Option
- Download the Order Form
- Fill this form with attendee details & payment details
- Fax it to +1-650-362-2367, or
- Email it to [email protected]
Payment Mode
ComplianceOnline (MetricStream, Inc),
6201 America Center Drive Suite 240
San Jose, CA 95002
USA
Register / Pay by Wire Transfer
Please contact us at +1-888-717-2436 to get details of wire transfer option.Terms & Conditions to Register for the Seminar/Conference/Event
Your registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-717-2436 or email us @ [email protected]
Payment:
Payment is required 2 days before the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. (our parent company).
Cancellations and substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund - less a $300 administration fee. No cancellations will be accepted - nor refunds issued - within 10 calendar days before the start date of the event.
On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($300) will be transferred to any future ComplianceOnline event and a credit note will be issued.
Substitutions may be made at any time. No-shows will be charged the full amount.
We discourage onsite registrations, however if you wish to register onsite, payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available, we will send the material after the conference is over.
In the event ComplianceOnline cancels the seminar, ComplianceOnline is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.
Attendance confirmation and documents to carry to the seminar venue:
After we receive the payment from the registered attendee, an electronic event pass will be sent to the email address associated with the registrant 5 working days before the seminar date. Please bring the pass to the venue of the event.
Conference photograph / video:
By registering and attending ComplianceOnline conference, you agree to have your photographs or videos taken at the conference venue and you do not have any objections to ComplianceOnline using these photos and videos for marketing, archiving or any other conference related activities. You agree to release ComplianceOnline from any kind of claims arising out of copyright or privacy violations.
We are pleased to offer several exhibitor, sponsorship and media partnership options designed to maximize your company's exposure and networking opportunities before, during and after the event.
Benefits of becoming a Sponsor/Exhibitor/Media Partner:
- Logo on website, marketing email, branding materials & the registration booth
- Exhibit Space
- Free event pass
- Speaking opportunity
- Social media campaign
For more details and other sponsorship options at this event, please contact Event Manager: [email protected] or call: +1-650-238-9656
Media Partner:
Local Attractions of New Brunswick, NJ
Zimmerli Art Museum
The Zimmerli Art Museum at Rutgers University is one of the largest and most distinguished university-based museums in the country. It collects, preserves, researches, and exhibits world-class works of art to provide the university community and diverse regional, national, and international audiences with direct experience of the visual arts.
American Hungarian Foundation
American Hungarian Foundation, New Brunswick has a significant Hungarian cultural presence, and the American Hungarian Foundation's mission is to communicate the story of American Hungarians through the Hungarian Heritage Center, which is the only facility of its type in the United States. The American Hungarian Foundation maintains a museum, a library and archives and offers tours.
Buccleuch Park
Buccleuch Park is a large park on Easton Avenue with hills for sledding, playing fields, a 1.5 mile trail, a playground and a rock garden. It is also home to historic Buccleuch Mansion, which, along with the park land, was willed to the city by the Bucclech family for the purpose of turning the land into a public park.
Rutgers Gardens
Rutgers Gardens are horticultural, display, and botanical gardens, including arboretums, located on the Cook Campus, Rutgers University, 112 Ryders Lane, North Brunswick in Middlesex County, New Jersey, in the United States. The gardens are open daily without fee.
Downtown
Downtown New Brunswick is home to a plethora of restaurants and bars. For entertainment, there are clubs such as Club Platinum for dancing and The Stress Factory for comedy. New Brunswick's nightlife is excellent for a city its size.
State Theatre
The New Brunswick State Theatre, located at 15 Livingston Avenue New Brunswick is a fantastic structured theatre which has had history pass through the doors, maintaining well known events constantly. This theatre underwent a $3 million restoration and renovation in 2003 and has become the highlight of the small city.
Rutgers University
Located in northeast New Brunswick, Rutgers University is a major aspect of the city. The College Avenue Campus is home to several dorms and lecture halls, with frathouses nearby. The Zimmerli Art Museum, Geology Museum, the Rutgers Student Center, and Old Queens (as a historic centerpiece) are places of attraction.
