NEW! Processing of cgmp Controlled Raw Materials

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NEW! Processing of cgmp Controlled Raw February 27, 2018 New Brunswick, NJ Directed by: Charity Ogunsanya, (Owner/CEO), Pharmabiodevice Consulting LLC Course Topics Include: FDA Regulations 21 CFR

CFR 110.80 Processes and Controls as well as applicable FDA regulations. Raw material control is a very critical part that ensures drug product quality, purity and potency.

1 NEW! Processing of cgmp Controlled Raw February 27, 2018 New Brunswick, NJ Directed by: Charity Ogunsanya, (Owner/CEO), Pharmabiodevice Consulting LLC Course Topics Include: FDA Regulations 21 CFR Review of 483s Case Studies Interactive Environment course description cgmp are the most critical ingredient of any product manufacturing step hence they must be controlled as stipulated in 21 CFR Processes and Controls as well as applicable FDA regulations. Raw material control is a very critical part that ensures drug product quality, purity and potency. Drug product manufacturers must have a defined procedure that clearly shows how raw materials are received, stored, labeled, quarantined, tested, qualified, tracked, used, and discarded at the end of expiry. This 1-day intensive training will provide guidance on the process steps associated with the handling and processing of cgmp Controlled Raw in order to avoid producing an adulterated product per 21 CFR Processes and Controls. This course consists of technical content, case studies, practical discussions and an exciting learning environment. This course offers the Virtual Attendee Option SAVE $200-Register & Pay by January 16

2 who should attend This training will benefit those involved in manufacturing, using, testing and Validating pharmaceutical gas systems in various industries such as the Pharmaceutical, Biotechnology, Drug, Biologics, Medical Device and In-vitro Diagnostics Product Manufacturing Industries, especially personnel and management in: Quality Assurance Quality Control Manufacturing Validation Supplier Quality Assurance Regulatory Affairs Shipping and Receiving Facility and Maintenance Engineering Management Professionals working as Laboratory Managers, Testing Analysts and Technicians, Suppliers and Vendors of Pharmaceutical Gas Systems and Microbiologists will find the training very worthwhile. learning objectives Upon completion of this course, you will be able to: Describe the appropriate ways to design the processing of all cgmp Controlled raw materials List the steps that every drug product manufacturer should follow in order to process all incoming cgmp controlled raw materials Develop defined procedures for receiving, storing, labeling, quarantining, testing, qualifying, tracking, and discarding controlled raw materials course outline 8:00 a.m.: Registration/Continental Breakfast 8:30 10:00 a.m.: Review Learning Objectives Regulatory Requirements Guiding cgmp Examples of cgmp How to Assess and Determine the Criticality of the cgmp Level I cgmp Level 2 cgmp Level 3 cgmp Handling, Receipt and Storage of cgmp 10:30 12:00 Noon: New Incoming cgmp Content of a New cgmp Controlled Material Test Example of a cgmp Controlled Material Processing the cgmp Controlled Material Test Approving the cgmp Controlled Material Test Issuing the cgmp Controlled Material Test course director Testing Requirements for all cgmp Controlled Performing the Testing of New and Unqualified Controlled Processing New and Unqualified cgmp Steps of Initial Qualification Testing of cgmp Documenting and Approving Initial Qualification Testing of cgmp Releasing cgmp Controlled Material after Performing Initial Qualification Testing Performing Routine Testing of Already Qualified cgmp Processing already qualified cgmp Controlled Steps of Routine Testing of cgmp Controlled Documenting and Approving cgmp Controlled after Routine Testing Releasing cgmp Controlled Material after Performing Routine Testing 1:00 2:30 p.m.: cgmp Yearly Confirmatory Testing Process Comparison Criteria Used in the Confirmatory Yearly Testing Performing Yearly Evaluation and Confirmatory Testing for Suppliers and Manufacturers of cgmp Evaluation of Suppliers and Manufacturers of Controlled after Approved Changes cgmp Controlled Material Testing Parameters How to Perform Disqualification of Testing Parameters 3:00 4:30 p.m.: How to Document Processed cgmp Controlled Document Review of Controlled Processing Failed cgmp Controlled Raw Investigating Out of (OOS) Test Results Associated with Failed Handling Rejected Review of Case Studies Case Studies FDA Form 483 s Inadequate Handling of cgmp Controlled Questions/Answers Assessment Opportunity Charity Ogunsanya has more than 26 years of extensive experience within the Biologics, Pharmaceuticals, Radiopharmaceuticals, Biotechnology and Medical Device Industries and has been the Microbiology, Sterility Assurance, Contamination Control, Aseptic processing, Quality Control Subject Matter Expert (SME) for multiple fortune 100 companies. She has a Bachelor of Science degree in Microbiology from the University of Benin-Nigeria and has a Masters degree from the Advanced Academic Master s Biotechnology Program at the Johns Hopkins University with concentration in Biotechnology/Biodefense. She is the CEO/ Owner of her consulting firm named Pharmabiodevice Consulting LLC. Her consultancy provides support to Biologics, Pharmaceuticals, Radiopharmaceuticals, Biotechnology and Medical Device Industries. For assistance contact Customer Service at 1/ or us at: info@cfpa.com For More Information or to Register Go to

3 course location This course will be held in the New Brunswick, New Jersey area. Specific hotel information will be sent to you in your final confirmation package which will be ed to you approximately three (3) weeks prior to the course start date. Please note that participants must make their own hotel reservations; the cost of the hotel accommodations is not included in the course fee. We recommend that travel/hotel arrangements not be made until final confirmation package is received. Easy access to Manhattan, Trenton, NJ and Philadelphia, all less than 40 minutes accreditations/recertifications for this course The Center for Professional Advancement (CfPA) has been approved as an Accredited Provider by the International Association for Continuing Education and Training (IACET), Sunrise Valley Drive, Suite 350, Reston, VA In obtaining this approval, CfPA has demonstrated that it complies with the ANSI/IACET Standards which are widely recognized as standards of good practice internationally. CfPA is therefore authorized to offer IACET CEUs for its programs that qualify under the ANSI/IACET Standards. CEUs will be awarded for participation in CfPA s courses at the rate of.1 CEU per contact hour upon successful completion of the entire course and 70% accuracy in the required Learners Assessment. This course offers a total of 6 contact hours, or.6 CEUs. who we are The Center for Professional Advancement (CfPA) is the largest accredited technical training organization in the world with a curriculum of approximately 450 short courses in 15 industries including Pharmaceutical, Biotechnology, Medical Device, Chemical, Cosmetics, Food and more. Since our founding in 1967, we have successfully trained nearly a half million people worldwide in topics ranging from basic and introductory concepts to new advances and cutting-edge technology, and current U.S. and European regulations. CfPA courses are offered in a variety of formats to fit you or your company s training needs: In Person: Away from responsibilities, participants are immersed without distraction Client Site: Training at your site and at your convenience. For further information, please contact Client Site Programs: +1/ , ext or clientsite@cfpa.com Online: A convenient and cost-effective way to experience our accredited training. For a list of upcoming courses visit Virtual Attendee: Ideal for those who need the training but cannot attend in person. For more information visit: virtual attendee training option About the Virtual Attendee Training Option Though attending in person at one of our courses is highly recommended, attending virtually is the next best thing when you can t be there. We will provide you with access to the complete live in person course via an internet connection and phone/audio speakers. You will receive a hard copy of the course notes, follow the same course schedule as the live course and see the slide presentation and hear the audio, in addition you will have the ability to participate and ask questions through the online chat. For complete information and FAQs visit: tuition Early Bird Save $100 (Must register and pay by January 16, 2018) $850 Regular Tuition $950 Virtual Live $760 Group Discount: Register 2 or more from the same company, at the same time, for this course and receive a 10% discount off each registration. Tuition payable in US funds net of all charges includes continental breakfast, luncheon, breaks and course notes. Note: Payment is due 2 weeks prior to course or at time of registration. For assistance contact Customer Service at 1/ or us at: info@cfpa.com For More Information or to Register Go to

how to register Online: www.cfpa.com enter Course ID# into Search. Click Register Now button. Group Rates Available: Save 10% on 2 or more attendees.

4 how to register Online: enter Course ID# into Search. Click Register Now button. Group Rates Available: Save 10% on 2 or more attendees. Call Customer Service at or info@cfpa.com Fill out the registration form and it to: info@cfpa.com registration form Processing of cgmp course id# 2778 /course offering# NJ2778 instructions: Please complete Registrant Information, Course Information and Payment Sections. Submit one form per individual registrant. o Check here if group discount applies (two or more enrollments for the same course, from the same company) All fields MUST be completed in order for registration to be accepted. registrant information Registration Type: o In Person Attendee o Virtual Attendee Prefix: o Ms o Miss o Mrs o Mr o Dr o Prof First Name Last Name Designation (i.e.phd, Jr) Address Alternate (copy sent here as well) Title Your position in the organization is (please check one) o Corporate o Line Operational o Managerial/Supervisory o Staff o Consultant Your primary job function is (please check one) o Clinical Practice o Project Management o Design Engineering o Quality Control Assurance o Environmental Safety o Research & Development o Legal or Regulatory Affairs o Technical Information Services o Manufacturing & Operations o Training and/or Education o Marketing or Sales o Other *Primary industry that best describes your area of interest (select maximum of 2) o Analytical Chemistry o Biopharmaceuticals/ Biotechnology o Chemical/ Process Engineering o Clinical/ Non-Clinical o Cosmetics/ Personal Care/ Household Products o Environmental and Safety Technology o Mechanical/ Design Engineering o Medical Devices/ Diagnostics o Packaging Technology o Petroleum Technology o Pharmaceutical Technology o Technical/ Project Management o Food Technology

5 contact information Company Name Address Zip/Postal Code City Country Phone Fax course information Course Title Course ID#/Offering# Tuition Tuition *How did you hear about us? o o Postcard o Colleague o Google Search o Social Media o Trade Show o Advertisement o Course Director o Course Brochure o Other discount code Discount Code payment information o Credit Card o Visa o Mastercard o American Express o Discover Card #: Exp. Date: Security Code: Cardholder Name: Signature: Billling Addess (if different from above) Address Zip/Postal Code City Country o Wire Transfer o Purchase order (PO# if applicable ) o Send Invoice o Check: Payable in US funds to: The Center for Professional Advancement terms and conditions Payment: Tuition payable in US funds net of all charges. Payment is due at time of registration or upon receipt of invoice. If payment has not been received two weeks before the course, a credit card will be required to guarantee registration. Discounts/Rates: To receive the Early Bird tuition rate, payment is required at time of registration and/or BEFORE early registration tuition expires or the regular tuition rate will apply. The Virtual Attendee Option does not qualify for Early Bird pricing. If choosing invoice/wire transfer, payment must be received prior to expiration of early registration tuition or the regular tuition rate will apply. All tuition prices are a per person rate. To qualify for the Group Rate discount, registration must be for two or more enrollments registering at the same time, from the same company, for the same course. Please note: Group Rate Discount cannot be combined with any other discount. Multiple discounts not applicable. Cancellations/Substitutions/FEES: ALL cancellations must be in writing and ed to: info@cfpa.com. All cancellations are subject to a $ cancellation fee. Applicants may cancel up to four (4) weeks prior to the course start date for a refund less cancellation fee. Applicants that cancel less than four (4) weeks prior to the course will be issued a credit less cancellation fee that can be used towards a future course up to one year from the date of issuance. If you do not cancel and do not attend you are still responsible for the full payment. If for any reason, CfPA decides to cancel this course, we are not responsible for airfare, hotel or other costs incurred by the registrant. Program content, schedule and instructors are subject to change without notice. Substitutions are permitted at any time, must be in writing and ed to Customer Service at info@cfpa.com. Confirmation Letters: Before each course begins, all registrants will receive written Final confirmation including detailed information regarding course location VIA . We recommend that travel/hotel arrangements not be made until final confirmation package is received. If confirmation is not received two weeks prior to the course please contact Customer Service at info@cfpa.com. Course photography / video: By registering and attending a CfPA course, you agree to have your photograph and/or video taken at the course venue, and you do not have any objections to CfPA using these photos and/or videos for marketing or any other CfPA Course and/or promotional purposes. You agree to release CfPA from any kind of claims arising out of copyright or privacy violations. All questions regarding this matter should be sent to Customer Service at info@cfpa.com. Please note: English will be used in all lectures and course notes. For questions/more information contact Customer Service at or info@cfpa.com. o I have read and agree to CfPA s Terms and Conditions

Pilot Plant and Scale-Up Studies Process Development and Scale-Up Methods How to Perform Pilot Plant Studies and Process Translation

Pilot Plant and Scale-Up Studies Process Development and Scale-Up Methods How to Perform Pilot Plant Studies and Process Translation Celebrating 50 YEARS 1 9 6 7-2 0 1 7 April 5-7, 2017 New Brunswick,