PDA 243 Current Good Manufacturing Practices CFR Parts 210 and 211
Registration Options
Individual Registration
Group Registration
This comprehensive training course is designed to equip attendees with in-depth knowledge and practical skills in navigating the intricacies of Current Good Manufacturing Practice (CGMP) regulations. Through interactive sessions, case studies, and hands-on exercises, participants will gain proficiency in the following key areas:
- Historical Overview: Participants will delve into the evolution of CGMP regulations, understanding the historical context and significant milestones shaping the current regulatory landscape.
- Regulatory Framework: Explore the legal basis underpinning CGMP regulations, including relevant statutes, guidelines, and compliance requirements enforced by regulatory authorities.
- Regulation Breakdown: Gain a thorough understanding of each CGMP regulation, dissecting its components, requirements, and implications for manufacturing practices.
- Self-Assessment: Learn to critically evaluate personal work practices and organizational procedures to identify potential CGMP deficiencies and violations.
- Application of Knowledge: Apply insights gained from CGMP regulations to propose effective changes and improvements to existing work practices and procedures, fostering a culture of compliance and continuous improvement.
By the end of this training, participants will emerge equipped with the expertise and confidence to navigate CGMP regulations adeptly, fostering a culture of compliance, quality, and excellence within their organizations.
Upon completion of this training course, the attendee will be able to:
- Summarize the history of the CGMP regulations
- Discuss the regulatory basis for the CGMP regulations
- Describe each of the CGMP regulations
- Evaluate their own work practices and procedures to identify CGMP deficiencies
For more options and/or related training courses, please visit the following page(s):
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Early Registration
Register by 02 August 2024
Member Price
$2,699GovernmentMember Only
$2,099
Health AuthorityMember Only
$2,099
AcademicMember Only
$2,099
Non-Member
$3,239
Standard Registration
Register after 02 August 2024
Member Price
$2,999GovernmentMember Only
$2,099
Health AuthorityMember Only
$2,099
AcademicMember Only
$2,099
Non-Member
$3,599
GROUP REGISTRATION DISCOUNT: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.
GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA immediately and will receive a credit (registration fee paid). PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. Video, photo, and audio recordings are prohibited at all PDA events.
CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to registration@pda.org.
Featured Trainers
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David J. Jaworski, MBA
Sr. Advisor Scientific Affairs, PDA
Read BioDavid J. Jaworski, MBA
PDA
David Jaworski has extensive experience in pharmaceutical manufacturing, international business management, and regulatory science. With a background of over 38 years in industry and most recently at the FDA, he strives at the PDA as a Senior Advisor to help members apply world class pharmaceutical and biotechnology practices, principles and methods to improve the quality of manufacturing facilities, employees, processes, and drug products. He has a Bachelor of Science Degree in Microbiology from Pennsylvania State University and a Master of Business Administration Degree in Operations and Management from Syracuse University. He has worked for major pharmaceutical companies, consultancies, and also at biotech start-up companies. At the FDA he started his career as a Consumer Safety Officer working in the CDER Office of Compliance and retired from the FDA as a Senior Policy Advisor in the Office of Manufacturing Quality. His expertise includes both sterile and non-sterile products; biotech API’s, devices, pharmacy compounding, as well as building new sterile facilities and innovative manufacturing processes. He has worked on the PDA/FDA Joint Conference planning committee, is a past Co-Chair, and has been a speaker at several PDA conferences. He also is a Vice President at Jaworski Associates, LLC.
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PDA Training and Research Institute
4350 East West Highway, Suite 110Bethesda, MD 20814, USA
Accommodations
The following hotels are located near the training course location:
Hilton Garden Inn
7301 Waverly Street
Bethesda, MD 20814
Hyatt Regency Bethesda
One Bethesda Metro Center
Bethesda, MD 20814
Residence Inn Marriott Bethesda Downtown
7335 Wisconsin Avenue
Bethesda, MD
20814