Pharmaceutical Training Courses

Featured Instructor

Priya Jambhekar
Specialties: Regulatory, Stability, Biotechnology, Management

Priya Jambhekar is a consultant with EAS Consulting Group and has over twenty years of experience in the areas of product development, product safety, quality assurance, quality compliance, clinical operations, supply chain management and US and international regulatory affairs. She has extensive experience in establishing regulatory strategy for Chemistry, Manufacturing Controls, Clinical and Nonclinical development for 1st in the class products and operational excellence for optimal success during all aspects of pre- and post- approval phases of new drugs, devices and biologics development and marketing of products covering various therapeutic areas, including metabolism and endocrinology, analgesic, anti-inflammatory, cardio-renal, pulmonary, oncology, gastrointestinal, dermatology, neurology, ophthalmology, urology, pain, anesthesia and addiction products. Priya also has significant experience in the generic industry and have successfully defended ANDA applications with Paragraph IV certifications.

Strategies instituted by Priya have led to company getting a 6-month generic market exclusivity for block buster drugs and have maintained 2 player market for extended period of time, pediatric and orphan drug exclusivities. Priya also has extensive experience in handling of controlled substances, DEA and PDMA registrations, post market safety and medical communication and Health Care Compliance. Proven experience in handling FDA pre-approval inspections and product plant compliance. She has managed over 250 NDA / IND / ANDA / PMA / 510(k) projects in various stages of development for registration around the globe (US, EU, Japan, Canada, Asia, Australia, South and Latin America).

Priya has held positions such as Global Sr. VP of Regulatory & Quality at Paramount BioSciences, Global VP at Ethicon, a J&J company and Alkermes. Some of the other positions include Baxter ACC as regulatory head and Bristol-Myers Squibb. Priya was a part of the management team at Cardiovations & GyneCare, J&J companies and Alkermes. Currently, Priya is a part of the management team of several companies advising them on regulatory, quality, supply chain matters and clinical operation.

Priya hold a M.Sc. in Organic & Biochemistry and M.S. in Pharmacy. She is also certified by Regulatory Affairs Professional Society and NJ Pharmaceutical Quality Control and Assurance Society.

Courses:

CfPIE training programs focus on the latest regulatory guidances issued by the FDA and EMA, as well as updates to FDA compliance and inspections involving GMP, GCP and GLP processes. Much of our life science training and pharmaceutical training course program centers on how to avoid warning letters by ensuring that your operational guidelines meet the latest regulatory compliance. These courses range from medical writing programs, clinical trial design and management, QA/QC training, as well as CMC, biologics, biotechnology and clinical research.

CfPIE also offers the widest range of pharmaceutical and medical device certification programs designed to enhance career advancement. Presently, over 3500 individuals are enrolled in Certification Programs covering GLP, GMP, Clinical Compliance, Process Validation, Global Regulatory Affairs, Document Management, QSR and CMC. Over 1200 have already completed Certification and advanced their careers.

In addition to the 300+ public courses offered annually, CfPIE is also the leading provider of on-site customized training to both industry and regulatory agencies around the world. Customers have included the FDA, NIH, EMA, US Defense Department, Saudi FDA, as well as numerous European based national regulatory bodies.

Our life science and pharmaceutical training course instructors frequently deliver FDA regulatory training topics designed to enhance inspection readiness, study design, clinical trial management, CMC guidance, computer system validation and the latest developments in medical device compliance.

CfPIE Frequently Asked Questions

Accounts & Registration

Q: Why do I need to create an account with CfPIE? I never had to create an account before.

A: Accounts are a new feature on our website. Creating a CfPIE account helps you view registration history and manage your training programs. All CfPIE course attendees must create an account. You must create an account even if you have taken classes with us in the past.

Q: How do I create an account with CfPIE?

A: When you register for a CfPIE training course, you will be prompted to create an account.

If you are registering yourself only, once you create an account you will be able to complete the checkout process.

Q: I would like to register myself and other people from my organization for a training course. How can I do this?

A: If you are registering yourself and other colleagues from your organization for a training course, please set up an account for each individual who is attending. This will allow that individual to access their account and track their training history.

Q: I am registering people other than myself for a training course. How can I do this?

A: If you are only registering other colleagues from your organization for a training course, please set up an account for each individual who is attending. This will allow that individual to access their account and track their training history.

Classroom Training

Q: What is included with the cost of my classroom course?

A: The course tuition covers the course itself, materials, breakfast, lunch and break-time refreshments. Class fees DO NOT include accommodations, airfare or other travel costs. However, we do have negotiated rates with hotels that host our courses – see below for a list.

Q: Where are your classroom training sessions held?

A: CfPIE courses are conveniently located near major airports and transportation to and from the course site is readily available. Please consult our course locations and transportation page to find the airport closest to you.

Q: What time does my classroom course start/finish?

A: On the first day of class, check-in begins at 8:30am, with the course starting promptly at 9:00am. In most cases, our two-day courses run from 9:00 am to 5:00 pm each day. Most of our three-day courses run from 9:00 am to 5:00 pm on the first two days and from 9:00 am to 3:00 pm the third day. Classroom hours will be listed in your "Registration Confirmation Email". When booking your return travel, we strongly recommend that departures be scheduled at least two hours after the course ends on the final day. Thus, please do not make your flight arrangements until your "Registration Confirmation Email" is received as some of our course times vary slightly.

Certifications

Q: How do I become Certified??

A: To obtain your certification, all you need to do is participate in three core courses and one elective course related to one of our 13 certification tracks (https://www.cfpie.com/content/programs.aspx). Once you complete the four courses, take the corresponding examinations and maintain an average minimum score of 70 percent, CfPIE will issue your certification credentials.

Q: How much does certification cost?

A: The total cost of certification is dictated by which individual courses you select and when you register (per our discount programs). There is no additional charge for certification above the standard course fee. All of our courses are either two or three days in length. The two-day courses are $1950 and the three-day are $2650. There is a $200 discount available per course if you register more than 30 days in advance or register for more than one course at a time.

Q: How can I participate?

A: Simply register for and attend the course, complete the exam and let us know which Certification Track you'd like to be enrolled in.

Q: Where do I take the exams?

A: Exams are made available on-line once the course is over. We will send you a link to the exams via email on the last day of the course. A history of your training and exams scores will be available when you access your account via our website. Individual course Attendance Certificates can also be printed from your account.

Q: How long is my certification good for?

A: Currently, we do not have an expiration date for our certification programs.

Q: Do I have to complete the courses in a certain amount of time?

A: No, but we suggest completing all four courses in a maximum of two or three years as courses are constantly updated to reflect changes in industry The average time taken to achieve Certification is 18 - 24 months.

Q: If I have already taken a course within the certification curriculum, can I take the test and have it count towards certification?

A: Yes, but only if you took that course within the last twelve months as our course content changes frequently.

Q: I noticed that some of the courses are too basic for me. Can I "test-out" of some of the more entry-level courses?

A: Yes, you are allowed to "test out" of ONE course for any certification track. However, you must attend three courses and complete the accompanying tests before "testing out" of the final course.

Cancellation Policy

Q: What is your cancellation policy?

A: Attendee Cancellation Policy – Classroom Courses
All cancellations must be in writing and are subject to a $350.00 cancellation fee. If cancellations are made more than 30 days prior to the course, a refund less the cancellation fee will be provided. If cancellations are made less than 30 days prior to the course, a voucher good for attendance at an upcoming course will be provided. The voucher, which can be used by the registrant or anyone else within his/her company, will be valued at the registration fee minus the $350.00 cancellation fee.

If a registered attendee does not cancel and fails to attend, neither a refund nor voucher will be issued. All course cancellations must be in writing and emailed sent to info@cfpie.com. Registrants are responsible for contacting the hotel and canceling their room reservations. CFPIE reserves the right to alter the venue, if necessary.

Substitution Policy – Classroom Courses
Substitutions are accepted at no penalty with written notification from the original registrant in advance of course. All substitution requests must be in writing and emailed to info@cfpie.com.

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