Pharmaceutical analysis is an important and integral part for the determination of quality including identity, purity and strength of the drugs. In addition, related studies and programs are needed to assure the performance of the drug products. It requires analysts to acquire a solid understanding of analytical chemistry and a thorough appreciation of pharmaceutical requirements to address these challenges. Each year the pharmaceutical industry worldwide recruits thousands of recent science graduates—especially chemistry, analytical chemistry, pharmacy, and pharmaceutical majors—into its ranks. However, because of their limited background in pharmaceutical analysis most of those new recruits find making the transition from academia to industry very difficult. This course is designed to assist both recent graduates, as well as experienced chemists or scientists with limited regulatory, compendial or pharmaceutical analysis background. The topics provide comprehensive introduction to the drug development, analysis and related studies for small molecule drugs (non-biologics).
The driving force for industry to perform pharmaceutical analyses is submission of such data and supporting documents to regulatory bodies for drug approval to market their products. Therefore, other related supporting studies such as analytical instrument qualification, analytical life cycle management (development, validation, verification, method transfer), setting specifications, stability studies, and regulatory or compendial approval are examined.
Due to global nature of pharmaceutical industry, other quality topics on both regulatory (ICH) and compendial harmonization are also covered. These topics are valuable for scientists directly or indirectly involved with the drug development, analysis. stability studies or regulatory/compendial submissions. This course is based on a recent book entitled "Pharmaceutical Analysis for Small Molecules" by Dr. Davani which has been published by Wiley in 2017. In addition, examples and case studies will be provided based on insights and extensive experience in developing and implementing these topics in industry/pharmacopeia. Guidance and advice will also be provided based on interactions with global pharmaceutical industry, FDA and other regulatory authorities worldwide
Learning Objectives:
- Drug Approval Process and Regulatory Requirements (private standards)
- Pharmacopeias and Compendial Approval Process (public standards)
- Compendial Harmonization Process
- Chromatography System Suitability Requirements
- Allowed Adjustments of Chromatographic System Parameters
- Common Methods in Pharmaceutical Analysis (typically compendial)
- Common Calculations for Assays and Impurities and Other Specific Tests
- Analytical Instrument Qualifications including DQ, IQ, OQ, PQ
- Analytical Method Validation
- Analytical Method Verification
- Analytical Method Transfer
- Specifications including how to Handle Out-of-Specification (OOS) and Out of Trend (OOT)
- Impurities including Organic, Inorganic, Residual Solvents and Elemental Impurities
- Alternative to Official procedure and options
- Stability Studies
- Degradation Studies
Who will Benefit:
Pharmaceutical Industry, Contract Laboratories (CRO), government (FDA or regulatory authorities), Academia
- Analytical/Chemists
- Lab Supervisors and Managers
- QC Managers and Personnel
- QA Managers and Personnel
- Regulatory Personnel
- Compendial Liaisons
- Pharmaceutical scientist/Pharmacists working in Industry
- Senior or Graduate students (chemistry, pharmaceutical, pharmacy)
- 8:30 AM - 8:59 AM: Registration and Meet & Greet.
- 9:00 AM - 10:00 AM: Lecture 1
- Seminar objectives review, expectations and scope.
- Drug Approval Process and Regulatory (FDA) Requirements (private standards)
- Pharmacopeias and Compendial (USP) Approval Process (public standards)
- 10:00 AM - 11:00 AM: Lecture 2
- Compendial Harmonization Process
- Chromatography System Suitability Requirements
- Allowed Adjustments of Chromatographic System Parameters
- 11:00 AM - 12:00 Noon: Lecture 3
- Common Methods in Pharmaceutical Analysis (typically compendial)
- Common Calculations for Assays and Impurities and Other Specific Tests
- 12:00 Noon - 1:00 PM: Lunch
- 1:00 PM - 2:00 PM: Lecture 4
- Analytical Instrument Qualifications
- Instrument Categories
- Qualification Phases (DQ, IQ, OQ, PQ)
- 2:00 PM - 3:00 PM: Lecture 5
- Analytical Method Validation (typical validation parameters)
- Specificity
- Precision/Accuracy
- Linearity/Range
- LOD and LOQ
- 3:00 PM - 4:00 PM: Lecture 6
- Analytical Method Verification
- FDA and USP Requirements
- Factors to Consider
- 4:00 PM - 4:30 PM: Lecture 7
- Analytical Method Transfer
- Different Approaches
- 8:30 AM - 8:59 AM: Registration and Meet & Greet.
- 9:00 AM - 10:00 AM: Lecture 8
- Seminar objectives review, expectations and scope.
- Setting Specifications FDA regulations and ICH guidelines (Q6A)
- Out-of-Specification (OOS)
- Out of Trend (OOT)
- How to handle OOS and OOT?
- 10:00 AM - 11:00 AM: Lecture 9
- Organic Impurities
- USP General Chapters <466>, <476>, <1086>
- ICH Guidelines (Q3A and Q3B)
- Classification
- Qualification
- 11:00 AM - 12:00 Noon: Lecture 10
- Residual Solvent
- ICH Q3C and USP <467>
- Classification
- Limits and Analysis
- 12:00 Noon - 1:00 Lunch
- 1:00 PM - 2:00 PM: Lecture 11
- Elemental Impurities
- ICH Q3D and USP <232> and <233>
- Other Types of Impurities
- Alternative to Official Procedure and Options
- 2:00 PM - 3:00 PM: Lecture 12
- Stability Studies (Q1A and other ICH Guidelines)
- Regulatory Requirements
- Stability Protocols
- Accelerated Studies
- Long-Term Studies
- Intermediate Studies
- 3:00 PM - 4:00 PM: Lecture 13
- Stability Studies (Continued)
- Bracketing and Matrixing
- Degradation (Stress) Studies
- 4:00 PM - 4:30 PM: Summary and Review
Behnam Davani
Senior Consultant and Managing Director, Davani Pharmaceutical Consulting
Dr. Behnam Davani is an Independent Senior Consultant and Managing Director of Davani Pharmaceutical Consulting. He has a Ph.D. degree in analytical chemistry and holds an MBA degree. Dr. Davani has more than 28 years of experience in industry, compendial/regulatory science and training. He has extensive experience as faculty for the development and teaching of several compendial and cGMP courses both domestically and internationally for USP Global Education Program. Dr. Davani is also editor and author of a recent book: "Pharmaceutical Analysis for Small Molecules", published by Wiley in 2017.
Prior to forming his own consulting company in 2017, he worked at USP for 17 years in different capacities including Director of Chemical Medicine Department and the Principal Scientific Liaison. His last responsibly at USP was the scientific management of the content development and teaching of USP Education courses for stakeholders worldwide. He was also a faculty for several Pharmacopeial Education courses both domestic and internationally. These topics include validation/verification/transfer of analytical procedures, impurities in drug substances and drug products, compendial HPLC, residual solvents, spectroscopy and stability studies for pharmaceutical products. In addition, he provided scientific support to the USP International Regulatory Affairs Department and Global Public Health Department for outreach and training for international regulatory agencies. Before joining USP in 1999, Dr. Davani worked in industry in various technical management positions for more than ten years.
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.
Offers:
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 Singapore
Singapore Zoo
Since 1973, Singapore Zoo has been known for having among the most beautiful wildlife park settings in the world, where animals roam freely in open and naturalistic habitats. The Singapore Zoo spans 28 hectares within Singapore's heavily forested central catchment area. The zoo, which attracts about 1.6 million visitors per year, boasts 315 animal species, some of 16% of which are considered threatened species.
Night Safari
The Night Safari is the world's first nocturnal zoo and is one of the most popular tourist attractions in Singapore. Today, the award-winning park welcomes more than 1.1 million visitors a year. They come from all over the world to enjoy the unique experience of seeing over 2,500 animals in their naturalistic nighttime habitats.
Universal Studios Singapore
Universal Studios Singapore is the first and only theme park in Southeast Asia. Go beyond the screen and Ride The Movies™ at Universal Studios Singapore. Only here can you experience cutting-edge rides, shows, and attractions based on your favorite blockbuster films and television series, including TRANSFORMERS The Ride: The Ultimate 3D Battle, Shrek 4-D Adventure, Madagascar: A Crate Adventure, Jurassic Park Rapids Adventure, and more!
Singapore Flyer
The Singapore Flyer is a giant Ferris wheel in Singapore that was constructed between 2005 and 2008. Described by its operators as an observation wheel, it reaches 42 storeys high, with a total height of 165 m (541 ft), making it the world's tallest Ferris wheel, 5 m (16 ft) taller than the Star of Nanchang and 30 m (98 ft) taller than the London Eye.
Underwater World, Singapore
Underwater World, Singapore is Asia's largest tropical oceanarium and one of Singapore's most popular tourist attractions. Opened in 1991, it has more than 2,500 marine animals of 250 species from different regions of the world. It is also involved in several environmental and educational projects, such as the Living in the Ocean Programme, Ocean Ambassador Programme and the Coral Club.
Boat Quay
Boat Quay is a zone offering an eclectic mix of high end restaurants and alfresco dining and lively bars and pubs. Boat Quay is arguably the favorite place to “chill out” for most professionals and expatriates. Lot of options available for drinks, dining from across the world. Most popular are the dining bars along the river. After a nice dinner one can head to one of the many pubs and discs around.
Sentosa Island
Sentosa is a popular island resort in Singapore, visited by some five million people a year. Attractions include a 2 km (1.2 mi) long sheltered beach, Fort Siloso, two golf courses, two five-star hotels, and the Resorts World Sentosa, featuring the theme park Universal Studios Singapore.
